ࡱ>    c e } ;bjbjPP ::J2UUcccccTcccd$kLFc\1<ƹp666j.`d0000000,5J8C0-chjjhhC0xcc664p0xxxhc6c60xh0xx(4Q-P'+>00`\1?+(9x(9|Q-xcQ-hhhC0C0xhhh\1(9hhhhhhhhhU pb:   Encoding of Oncology Clinical Trial Read Results in DICOM SR Abbreviated QIBA 1C Content Document Author(s)NameOrganizationSignatureDateDavid ClunieCoreLab Partners Revision History VersionDateAuthor(s)Description2.11-Q23 Nov 2011David ClunieExtract relevant to content used in QIBA 1C reader experiment; green highlights rows used. Encoding of Oncology Clinical Trial Read Results in DICOM SR Version 2.11-Q DAC 2011/11/23 Table of Contents  TOC \o "1-3" Revision History  PAGEREF _Toc183657530 \h 2 Encoding of Oncology Clinical Trial Read Results in DICOM SR  PAGEREF _Toc183657531 \h 3 Table of Contents  PAGEREF _Toc183657532 \h 3 Introduction  PAGEREF _Toc183657533 \h 6 Scope of an SR Instance  PAGEREF _Toc183657534 \h 7 Other Instances Referenced From An SR Instance  PAGEREF _Toc183657535 \h 8 Structure  PAGEREF _Toc183657536 \h 9 Extensibility.  PAGEREF _Toc183657537 \h 12 Information Model  PAGEREF _Toc183657538 \h 12 Codes and Coding Scheme Version  PAGEREF _Toc183657539 \h 13 Templates  PAGEREF _Toc183657540 \h 13 TID RPH_0001 Clinical Trial Results Document Root  PAGEREF _Toc183657541 \h 15 TID RPH_0002a Person Observer Identifying Attributes  PAGEREF _Toc183657542 \h 16 TID RPH_0002b Device Observer Identifying Attributes  PAGEREF _Toc183657543 \h 17 TID RPH_0002c Clinical Trial Protocol Context  PAGEREF _Toc183657544 \h 18 TID RPH_0002d Subject Context  PAGEREF _Toc183657545 \h 19 TID RPH_0003 Reading Session and Task Context  PAGEREF _Toc183657546 \h 20 TID RPH_0004 Time Point Context  PAGEREF _Toc183657547 \h 21 TID RPH_0005 Time Point Observations  PAGEREF _Toc183657548 \h 24 TID RPH_0005b Adjudication Observations  PAGEREF _Toc183657549 \h 26 TID RPH_0006 Time Point Lesion Observations  PAGEREF _Toc183657550 \h 27 TID RPH_0006b General Lesion Observations  PAGEREF _Toc183657551 \h 31 TID RPH_0007 Measurement Objects  PAGEREF _Toc183657552 \h 33 TID RPH_0007a Simple Measurements  PAGEREF _Toc183657553 \h 38 TID RPH_0007b Sub-Regions and Measurements  PAGEREF _Toc183657554 \h 40 TID RPH_0007c Text Annotations  PAGEREF _Toc183657555 \h 44 TID RPH_0007d Measurements Derived From Other Measurements  PAGEREF _Toc183657556 \h 45 TID RPH_0009 Region Measurements  PAGEREF _Toc183657557 \h 46 TID RPH_0010 Clinical Trial Results Image Library Entry Template  PAGEREF _Toc183657558 \h 47 TID RPH_0020 Audit Trail Entry Template  PAGEREF _Toc183657559 \h 50 Context Groups  PAGEREF _Toc183657560 \h 53 CID RPH_7001 Clinical Trial Performing Roles  PAGEREF _Toc183657561 \h 53 CID RPH_7001b Clinical Trial Adjudicated Roles  PAGEREF _Toc183657562 \h 55 CID RPH_7002 Clinical Trial Worklist Task Type  PAGEREF _Toc183657563 \h 55 CID RPH_7003 Clinical Trial Worklist Task Category  PAGEREF _Toc183657564 \h 56 CID RPH_7003b Clinical Trial Worklist Task Levels  PAGEREF _Toc183657565 \h 56 CID RPH_7003c Clinical Trial Worklist Task Repeat Types  PAGEREF _Toc183657566 \h 57 CID RPH_7003d Clinical Trial Worklist Task Variability Types  PAGEREF _Toc183657567 \h 57 CID RPH_7004 Lesion Type  PAGEREF _Toc183657568 \h 58 CID RPH_7006 Anatomic Sites for Lesions  PAGEREF _Toc183657569 \h 58 CID RPH_7006a Anatomic Sites for CNS Lesions  PAGEREF _Toc183657570 \h 59 CID RPH_7006b Anatomic Sites for Lesions Nodes  PAGEREF _Toc183657571 \h 60 CID RPH_7006c Anatomic Sites for Lesions Viscera and Soft Tissue  PAGEREF _Toc183657572 \h 62 CID RPH_7006d Anatomic Sites for Lesions Skeletal  PAGEREF _Toc183657573 \h 65 CID RPH_7006e Anatomic Sites for Lesions Skin  PAGEREF _Toc183657574 \h 68 CID RPH_7006f Anatomic Sites for Lesions Fluid Collections  PAGEREF _Toc183657575 \h 69 CID RPH_7007 Anatomic Regions for Radiology Procedures  PAGEREF _Toc183657576 \h 69 CID RPH_7007b Anatomic Regions for External Photography Procedures  PAGEREF _Toc183657577 \h 72 CID RPH_7010 Non-Target Lesion Response  PAGEREF _Toc183657578 \h 75 CID RPH_7010b PET Target Lesion Qualitative Response  PAGEREF _Toc183657579 \h 75 CID RPH_7010c PET Lesion Qualitative Assessment  PAGEREF _Toc183657580 \h 76 CID RPH_7011 Reasons Unable to Evaluate Lesion  PAGEREF _Toc183657581 \h 76 CID RPH_7012 Reasons Unable to Measure Target Lesion  PAGEREF _Toc183657582 \h 77 CID RPH_7012b Reasons Unable to Measure New Lesion  PAGEREF _Toc183657583 \h 78 CID RPH_7013 Lesion Change Reasons  PAGEREF _Toc183657584 \h 78 CID RPH_7013b Lesion Addition Reasons  PAGEREF _Toc183657585 \h 79 CID RPH_7013c Calibration Change Reasons  PAGEREF _Toc183657586 \h 79 CID RPH_7014 Time Point Change Reasons  PAGEREF _Toc183657587 \h 80 CID RPH_7014b Adjudication Change Reasons  PAGEREF _Toc183657588 \h 80 CID RPH_7014c Time Point Observation Addition Reasons  PAGEREF _Toc183657589 \h 81 CID RPH_7015 Signature Meanings  PAGEREF _Toc183657590 \h 81 CID RPH_7016 Algorithm Type  PAGEREF _Toc183657591 \h 82 CID RPH_7017 Single Line Segment Measurements  PAGEREF _Toc183657592 \h 82 CID RPH_7018 Region Linear Measurements  PAGEREF _Toc183657593 \h 83 CID RPH_7019 Region Area Measurements  PAGEREF _Toc183657594 \h 84 CID RPH_7020 Region Volume Measurements  PAGEREF _Toc183657595 \h 84 CID RPH_7021 Region Pixel Value Measurements  PAGEREF _Toc183657596 \h 85 CID RPH_7022 Measurements Derived From Other Measurements  PAGEREF _Toc183657597 \h 85 CID RPH_7031 Time Point Numeric Observations  PAGEREF _Toc183657598 \h 86 CID RPH_7032 Time Point Numeric Observation Units  PAGEREF _Toc183657599 \h 87 CID RPH_7030 Measurement Derivation Modifiers  PAGEREF _Toc183657600 \h 87 CID 3488 Min/Max/Mean  PAGEREF _Toc183657601 \h 87 CID 7473 General Area Calculation Methods  PAGEREF _Toc183657602 \h 88 CID 7474 General Volume Calculation Methods  PAGEREF _Toc183657603 \h 88 CID RPH_7040 Region Segmentation Methods  PAGEREF _Toc183657604 \h 89 CID RPH_7041 Automation  PAGEREF _Toc183657605 \h 89 CID RPH_7050a Adjudication Choice Reasons  PAGEREF _Toc183657606 \h 90 CID RPH_7050b Adjudication Discordance Reasons  PAGEREF _Toc183657607 \h 91 CID RPH_7052 Adjudication Observation Scope  PAGEREF _Toc183657608 \h 92 CID RPH_7060 Message Digest Algorithms  PAGEREF _Toc183657609 \h 92 CID RPH_7070 Closed Curve Types  PAGEREF _Toc183657610 \h 93 CID RPH_7071 Closed Polygon Types  PAGEREF _Toc183657611 \h 93 CID RPH_7080 Procedures Reported  PAGEREF _Toc183657612 \h 94 CID RPH_7081 NM Procedures Reported  PAGEREF _Toc183657613 \h 94 CID RPH_7082 MR Procedures Reported  PAGEREF _Toc183657614 \h 95 CID RPH_7083 BMD Procedures Reported  PAGEREF _Toc183657615 \h 95 CID RPH_7230 Yes-No Only  PAGEREF _Toc183657616 \h 95 CID RPH_7231 Yes-No-UE  PAGEREF _Toc183657617 \h 96 CID RPH_7601 Measurement Object Types  PAGEREF _Toc183657618 \h 96 CID RPH_7602 3D Geometric Object Types  PAGEREF _Toc183657619 \h 97 CID RPH_7702 Multiplicity  PAGEREF _Toc183657620 \h 97 CID RPH_7710 Baseline Time Point Observation Types With Yes-No Answers  PAGEREF _Toc183657621 \h 98 CID RPH_7711 Post-Baseline Time Point Observation Types With Yes-No Answers  PAGEREF _Toc183657622 \h 98 CID RPH_7712 Post-Baseline Time Point Observation Types With Yes-No-UE Answers  PAGEREF _Toc183657623 \h 98 CID 29 Acquisition Modality  PAGEREF _Toc183657624 \h 99 CID 230 Yes-No  PAGEREF _Toc183657625 \h 100 CID 244 Laterality  PAGEREF _Toc183657626 \h 101 Code Definitions  PAGEREF _Toc183657627 \h 102 DICOM SR Header ATTRIBUTES  PAGEREF _Toc183657628 \h 125 Comprehensive SR IOD Module Table  PAGEREF _Toc183657629 \h 125 Patient Module  PAGEREF _Toc183657630 \h 126 SR Document Series Module  PAGEREF _Toc183657631 \h 129 SR Document General Module  PAGEREF _Toc183657632 \h 131 SR Document Content Module  PAGEREF _Toc183657633 \h 132 Container Macro  PAGEREF _Toc183657634 \h 132 C.12.1 SOP Common Module  PAGEREF _Toc183657635 \h 133  Introduction The objective of this document is to define a persistent format for storing the results of image-based oncology clinical trials with an encoding as a DICOM Structured Report. The applications include: Saving and restoring (for display and editing) of lesions and comments (with presentation state information) within a visual reading tool Saving and restoring of state information (such as whether or not work has been completed and changes made) Saving and restoring of adjudication (result comparison) information Extraction of selected quantitative and qualitative information with appropriate context for transfer into data management systems and other database-oriented systems Exchange of information with other review and visualization tools, including display on ordinary DICOM-based clinical PACS workstations Migration of lesions and comments from legacy applications that use proprietary formats or other DICOM encoding mechanisms (such as RT Structure Sets) The SR encodes both the results themselves (e.g., numeric values for measurements, coded values for responses, and plain text values for human-entered comments), as well as the locations on the images where lesions are located and from which the measurements are derived, except in the case where lesions are defined by rasterized bitmaps, in which case references to external Segmentation Storage SOP Instances are used. Scope of an SR Instance The term observation rather than lesion or comment or adjudication result is used to include any type of information gathered during human or machine interpretation, to be consistent with standard DICOM SR terminology. The scope of a single SR SOP Instance is the cumulative set of all of the observations made (work done) by a single reader role for a single subject, which includes: All observations created for the current time point Any additional observations added to previous time points Any changes to observations from previous time points, whether by the same user or a different user (e.g., if the current user has permission to change the work of another user, perhaps in the same reader role) All of the observations made in previous sub-tasks, whether incomplete sub-tasks about the current time-point, or completed sub-tasks about previous time points, whether by the same user, or by a different user in the same reader role (i.e., a substitute reader) This implies that: This single SR SOP Instance constitutes all the new and changed observations from a single sub-task, as well as all previous sub-tasks. Observations from previous completed (signed aka. Verified) sub-tasks (whether by the same or a different user in the same reader role) are copied into the new SR SOP Instance. Observations from previous incomplete (unsigned aka. Unverified) sub-tasks are also copied into the new SR SOP Instance. When a sub-task is closed (as complete or incomplete, signed or not), it is always given a new SOP Instance UID, and the previous SOP Instance then becomes redundant (though it is still referenced as the predecessor). This single SR SOP Instance can be electronically signed (recorded as complete and verified) by the user; the scope and meaning of the signature are all of the observations made in the sub-task (whether they be new or changes) such that the user creating the work is signing for their own work only, and verification that they reviewed the work of previous sub-tasks, whether performed previously themselves, or by other users in the same reader role. Multiple users in different reader roles may be working on the same image data simultaneously and recording their own observations (which are recorded in separate instances). Establishing the state of all observations (all work done) on a subject for a specified reader role requires loading only the single most recent SR SOP Instance for that subject and reader role predecessor SR SOP Instances do not need to be (and should not be) loaded; there is no need to merge SR SOP Instances created in multiple successive sub-tasks. Detecting the difference between what was done in the previous sub-task and the current sub-task can achieved by either comparing the current and predecessor SR SOP Instances, or by examining the (RP-100920, 99RPH, Observation Creation DateTime) of each observation of the current SR SOP Instance relative to the current sub-task start time ((RP-100924, 99RPH, Worklist Sub-task Start DateTime)); this is necessary to determine what to load into another system to record the work done in the current sub-task (e.g., to batch load Oracle Clinical with the new and changed results) If necessary, an application could render a visual audit trail by showing explicitly what the state of the observations was at each step of the process at the granularity of either the sub-task level, by loading the corresponding SR SOP Instance, or at the Content Item level, by comparing Content Items from successive SR SOP Instances. The burden to establish what constitutes the same lesion (distinguished by a tracking unique identifier) is on the observation creator or modifier, not the recipient; i.e., each new lesion is assigned a globally unique identifier, and each modified observation, whether modified by the same user or a different user, retains the same globally unique identifier, regardless of in which SR SOP Instance(s) the observation is recorded; in this manner, the recipient is not required to attempt to disambiguate two observations with the same label (e.g., lesion 1) that were made in different user roles (e.g., reader 1 and reader 2), since these would have different tracking unique identifiers, whereas a single observation (e.g., lesion 1) created by one user (e.g., smith) and modified by another (e.g., jones), perhaps in the same user role (e.g., reader 1) would have the same tracking unique identifier; when a lesion splits, each of the new split components is assigned a new tracking unique identifier and a reference to the tracking unique identifier of its predecessor (parent) is recorded; in this way they are explicitly linked, but distinct entities. Likewise for lesions that coalesce (merge). Other Instances Referenced From An SR Instance The SR Instance does not alone completely define the information captured during a read. It will contain as necessary references to other DICOM SOP Instances, including: The original images on which measurement objects using 2D spatial coordinates are made. Segmentation instances that encode the rasterized bitmap of the area that constitutes a 3D measurement object Presentation States that encode the pan, zoom and windowing state of a (set of) image frames when a measurement object was created or edited (these will be grayscale or color depending on the image to which they apply) Derived images created and stored from MPR visualizations for 2D measurements made on planes other than the original images (which will be of a modality appropriate SOP Class, or an appropriate Multi-frame Secondary Capture SOP Class with 3D position and orientation information encoded) Registration instances that encode the results of rigid registration between different frames of reference used during the read Note that it is a requirement of the DICOM SR definition that ALL such SOP Instances that are referenced in the SR Content tree also be listed in the Current Requested Procedure Evidence Sequence (0040,A375). See DICOM PS 3.3 C.17.2.3. All of the DICOM Patient (i.e., subject) level information in the SR and other instances shall be consistent (and consistent with the original images from which they were derived). Consistent does not necessarily mean identical, in that there may be more information about the subject in some instances than others (e.g., a value for Patients Sex present in the images, but not replicated into the SR). All such other instances created shall have the same Study Instance UID, Study Date and other Study level information as is encoded in the images from which they were derived, if there is only one such study. I.e., a saved derived image, or a presentation state, or a segmentation instance will all share the same study as the images from which they were derived, and NOT the Study information of the SR Instance that references them. In the case of other instances that are derived from multiple Studies (e.g., a registration that spans different Studies in the same or different time points), they shall be encoded with the Study information of the most recent Study from which they are derived. All such other instances created shall be in a new Series within that Study, since DICOM requires that instances from different equipment and with different modalities (e.g., SEG for segmentation, PR for presentation states and REG for registration) be in different Series. Since the scope of an SR instance includes work performed on previously encoded sub-tasks, which in the case of a sequential read includes observations made on studies for previous time points, by definition the cumulative SR instance that records the work will include references to non-SR instances that were generated during earlier sub-tasks. These shall continue to be referenced by their original SOP Instance UIDs and do not need to be copied or re-stored. This implies that they will remain in the same Study (with the same Study Instance UID and Study Date) as they were when they were created. If a change to the content related to such an instance is edited, however, a new SOP Instance shall be generated, and subsequent references from SR objects will be to the new instance only. The old instances will only be referenced by the old SR instances. At any point in time, the entire collection of instances related to a subjects original images, SR instances, and all other related instances will contain both old (irrelevant) and current (relevant) information, The references from the most current SR instance define what constitutes what is current, relevant and active; anything not referenced from the current SR instance is old, irrelevant and stale and should not be used or displayed (except to review the audit trail). The active subset can be determined from the Current Requested Procedure Evidence Sequence (0040,A375) attribute, or by enumerating all the references in the content tree. Structure The templates defined here specify a hierarchical organization, though some of the hierarchy is implicit in the ordinary DICOM header attributes rather than within the SR Content Sequence tree; specifically: the clinical trial protocol information (the top of the tree) is specified in the various Clinical Trial Modules the subject information (the second layer of the tree) is specified both in the Patient Module and the relevant attributes of the Clinical Trial Modules the Study information (e.g. DICOM Study Date and Study Time) are the characteristics of the most recent time point, though there may be multiple imaging Studies from different time points used during a single reading sub-task (see General Study Module Attributes table) The levels of information below the subject are specified in the SR Content Sequence through successive nesting; specifically: all information about the (single) reader (e.g., which user and in which reader role) who created the SR SOP Instance is grouped together at the top level of the content tree (observer context) observations made in a previous sub-task by an earlier, different user in the same reader role (which makes the current reader a substitute reader) are attributed with audit trail information to record who actually made those earlier observations that are contained (quoted) by value. the work list task and sub-task are explicitly described for the current sub-task and any previous sub-tasks; the current sub-task, i.e., the one in which the SR instance was generated, is apparent from a) its most recent TID RPH_0003 Row 13 (RP-100925, 99RPH, Worklist Sub-task Closed DateTime), and b) in the case of a completed and verified (signed) sub-task, the match with the value of Verification DateTime (0040,A030) the one or more time point(s) within an SR instance are described separately from the sub-tasks, since there is not a 1:1 correspondence between time points and sub-tasks (e.g., multiple time points may be modified within a single sub-task); the sub-task within which each observation in a time point is created or modified can be determined from the (RP-100082, 99RPH, Worklist Sub-task UID) with in the accompanying audit trail entries (TID RPH_0020) the Clinical Trial Timepoint related header attributes are NOT used, since they can only have a single value, and there may be observations about one or more time points rather than a single time point with a single instance, and there is not necessarily a single current time point, depending on the type of read observations about a time point itself are included at the time point level (e.g. time point comments) image library entries are included at the time point level the common characteristics of certain types of observations (i.e., lesions) that span multiple time points are factored out and listed separately from the time point level all other observations (e.g., about lesions found on images for a particular time point and lesions that have no corresponding images for a particular time point) are listed below the time point level the date/time stamp of every observation is encoded in the (RP-100920, 99RPH, Observation Creation DateTime) and (RP-100921, 99RPH, Observation Modification DateTime) and content item of every observation, rather than relying on the Observation DateTime (0040,A032), which may or may not be present in a content item, and has no specific semantics with respect to creation, modification or addition. the presentation state (zoom, pan, windowing, etc.) captured at the time when a measurement or other annotation is created or edited on an image, is not encoded directly in the SR; rather it is encoded in a separate DICOM Presentation State instance, and a reference to that instance is recorded within the attributes of the IMAGE Content Item itself, not stored as separate Content Items in the SR tree (i.e., in the Referenced SOP Sequence (0008,1199)); see PS 3.3 C.18.4 Image Reference Macro for a multi-frame image, the selected frame number is encoded in the Referenced Frame Number (0008,1160) of the IMAGE Content Item; see PS 3.3 C.18.4 Image Reference Macro the rasterized bitmap of a 3D measurement or other annotation is recorded as a separate instance of the Segmentation IOD, and referenced from an IMAGE Content Item not stored within the SR tree; see PS 3.3 C.18.4 Image Reference Macro; there shall be one Segment in the Segmentation Storage SOP Instance, it shall always have a Segment Number of 1 (and hence the referenced Segment Number in the IMAGE Content Item shall also always be 1); it shall have a Segmentation Type (0062,0001) of FRACTIONAL, and a Segmentation Fractional Type (0062,0010) of PROBABILITY, will be 8 bits deep with stored pixel values of 0 and 255 only (representing 0 and 100% respectively); if the 3D object spans multiple slices, then there shall be a single Segmentation instance that contains multiple frames. all images referenced from within the content tree are required to be listed in the top-level attribute Current Requested Procedure Evidence Sequence (0040,A375), which encodes: the Series and Study instance UIDs in addition to the SOP Instance UIDs of the images optionally, a Referenced SOP Instance MAC Sequence (0400,0403), which allows a hash (Message Authentication Code) value to be stored to later verify the integrity of selected attributes (e.g., the Pixel Data) (i.e., that the value has not changed (in a different version of the image) since the measurement was made); see PS 3.3 C.17.2.1 and C.12.1.1.3.1.2 the electronic signature is recorded in the top level DICOM header and not in the DICOM content tree; specifically: whether signed or unsigned, the Author Observer Sequence (0040,A078) shall contain the users identity unsigned (sub-task closed as incomplete) documents shall have the Verification Flag (0040,A493) set to UNVERIFIED, the Completion Flag (0040,A492) set to PARTIAL and the Verifying Observer Sequence shall be absent (NOT present but empty) signed (sub-task closed as complete) documents shall have the Verification Flag (0040,A493) set to VERIFIED, the Completion Flag (0040,A492) set to COMPLETE and the Verifying Observer Sequence (0040,A073) shall contain a single sequence item that contains the Verifying Observer Name (0040,A075) code with a value that is the full name (not user id) of the user, a Verifying Observer Identification Code Sequence (0040,A088) that contains a single sequence item that contains the user id as the Code Value, the full name as the Code Meaning and a Coding Scheme Designator of 99RPH_USERS a Verifying Organization (0040,A027) of RadPharm, Inc. a Verification DateTime (0040,A030) that is the UTC date/time stamp of the signature (which will be the same value as the TID RPH_0003 Row 13 (RP-100925, 99RPH, Worklist Sub-task Closed DateTime)) the reason for signature of the document is encoded in the content tree, since there is no DICOM header attribute for this concept at the present time (cryptographic digital signatures, for which there is Digital Signature Purpose Code Sequence (0400,0401), are not used in this application at this time); a CoreLab Partners-specific value set is also used, since the reasons for signature differ from the ASTM standard codes used for clinical document signatures (see PS 3.16 CID 7007 and ASTM E 2084-00). if appropriate depending on the read paradigm, the time points and observations within those time points will have their Completed flag set to YES in the content tree. all DICOM SR documents have verification status of either UNVERIFIED or VERIFIED, which corresponds to unsigned or signed, and have a completion status of either PARTIAL or COMPLETE, independent of the verification status; theoretically, a SR document could be completed, but signed (verified) later; the planned workflow though is to insist on a signature prior to completion (and persistence of both simultaneously). there is no current requirement for a cryptographic digital signature either of the individual user or the organization creating the SR instances, and we have no public key certificate infra-structure deployed at this time or immediate plans to do so; this also implies that that the use of cryptographic digital signatures to verify that referenced instances (images, segmentations, presentation states) have not changed (as described in PS 3.3 Table C.17-3 SOP Instance Reference Macro and Section C.12.1.1.3 Digital Signatures Macro) is also not used at this time, and specific content items to contain a message digest for all such references are used instead. Extensibility. The basic templates defined here describe the minimal information that is required for ordinary RECIST or WHO style oncology eligibility and primary reads and adjudication. The templates are extensible, so it is possible to add new content items at any location in the content tree. For instance, if a particular protocol requires that a specific question be asked of the user about a lesion (e.g., is there an associated fracture ? yes/no), then an additional content item can be added at the lesion level (i.e., a child of Row 1, EV (100025, 99RPH, Lesion), with a CONTAINS relationship, in TID RPH_0006) that contains a new CODE content item with a Concept Name code corresponding to the question (e.g., EV (xxxxxx, 99RPH, Fracture Present)) with a value set of DCID (RPH_7230) Yes-No Only. Another example is when a protocol requires that a new lesion seen on a bone scan be confirmed on another modality. It is necessary to record that together with the bone scan lesion metadata; an additional content item can be added at the lesion level (i.e., a child of Row 1, EV (100025, 99RPH, Lesion), with a CONTAINS relationship, in TID RPH_0006) that contains a new CODE content item with a Concept Name code such as EV (xxxxxx, 99RPH, New Bone Scan Lesion Confirmed), with a value set containing codes for (CT, DCM, Computed Tomography), (MR, DCM, Magnetic Resonance), (RG, DCM, Radiographic Imaging) and (R-00339, SRT, No). See PS 3.16 CID 29 Acquisition Modality for a standard set of modality codes. Existing standard codes for values should be used whenever possible when extending the templates (see DICOM PS 3.16 for all the standard codes and sources of external coding schemes supported by DICOM). In this manner, applications that are aware of and expecting the extended content can find and use the information, and older applications can gracefully ignore the extended content. Information Model The following entities are explicitly defined in a hierarchical information model: Clinical Trial Results Reading Sub-tasks (steps within a work list task, e.g., to read a single time point in comparison with previous time points) Time Points Studies Lesions (which may or may not be related to an image) Measurement Objects (both to define lesions and to define locations for additional measurements about lesions) Observations (including measurements, response categories and comments) Measurements (a specific type of observation, distinguished by reference to image regions) Adjudication results (a specific type of observation) Readers (person observers in DICOM SR nomenclature) The relationships between these entities, and their attributes (SR content items), are illustrated in the accompanying UML model document. The normative reference for the content however, is the set of templates, context groups, code values, and modules described herein. Because the scope of an individual SR instance is the cumulative result of execution of multiple sub-tasks, yet those sub-tasks may include changes to time point observations created in previous sub-tasks, the time point entity is NOT sub-ordinate to the sub-task entity. Rather a separate tree of time point information that represents the cumulative state is encoded, with each observation therein attributed with the sub-task UID of the sub-task in which it was created or modified. Another separate tree of task and sub-task descriptive information is maintained, within which sub-task information can be identified by sub-task UID. Note: The information model does not attempt to model references to predecessor documents and objects within predecessors (such as lesions with the same tracking longitudinal unique identifiers, and lesions that merge and split), though such relationships are defined in the templates. Codes and Coding Scheme Version When existing appropriate codes for concepts are available, such as from SNOMED, DICOM or Radlex, these are used in the templates and context groups. When necessary, private CoreLab Partners-specific codes are defined for concepts not yet in any know standard terminology. These shall use a Coding Scheme Designator of 99RPH Codes for units are encoded using UCUM. In all cases, when a UCUM code is used the Coding Scheme Version (0008,0103) attribute is also required, in addition to the usual tuple of Code Value, Coding Scheme Designator and Code Meaning (see DICOM PS 3.16 Section 7.2.2). Unless otherwise specified, the value for all UCUM codes for Coding Scheme Version shall be 1.4. Coding Scheme Version shall not be present for SNOMED, DICOM, RadLex or 99RPH codes. Templates The templates that comprise the Clinical Trial Results Document Root are related as illustrated in the following figure. The Root Template (RPH_0001 of 99RPH) shall be identified in the DICOM Instance by inclusion of the Content Template Sequence (0040,a504) Attribute in the top level dataset, with a single item as described in the  REF _Ref100384549 \h Container Macro Section. Notes: 1. This figure does describe the entity-relationship model, since some entities and their attributes and relationships are described as individual content items within templates, rather than as separate templates, and templates may be nested within child content items of other templates. 2. The templates make use of and/or reference to standard DICOM SR templates and context groups (value sets) defined in DICOM PS 3.16 2011, without replicating that information herein, except where necessary for clarity. 3. The inclusion of the Template Identifier allows receiving applications to confirm that the SR is of the correct type, since the SOP Class UID is not sufficient to distinguish clinical trials results or any other type of content that might be encoded in a Comprehensive SR SOP Class, nor is the top level concept name in the content tree (the Document Title) necessarily unique to the RPH_0001 template.  EMBED Word.Picture.8  TID RPH_0001 Clinical Trial Results Document Root TID RPH_0001 CLINICAL TRIAL RESULTS DOCUMENT ROOT Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINEREV (RP-100001, 99RPH, Clinical Trial Results)1M2>HAS CONCEPT MODINCLUDEDTID (1204) Language of Content Item and Descendants1MFor English, use (eng,RFC3066,English); do not use ISO939_2 as the coding scheme.3>HAS OBS CONTEXTINCLUDEDTID(RPH_0002a) Person Observer Identifying Attributes1MThe human who performed the read. The scope of this (single) entry is the entire document, which includes all observations, regardless of task, sub-task, time point or any other entity in the hierarchy, except for any observations made by other individuals that are included, which are always identified as such in individual audit trail entries.4>HAS OBS CONTEXTINCLUDEDTID(RPH_0002b) Device Observer Identifying Attributes1M4b>HAS OBS CONTEXTINCLUDEDTID(RPH_0002c) Clinical Trial Protocol Context1M4c>HAS OBS CONTEXTINCLUDEDTID(RPH_0002d) Subject Context1M5>CONTAINSCONTAINEREV (111028, DCM, Image Library)1MCRequired if images are referenced from observations.E.g., all IMAGE children of SCOORDs6>>CONTAINSINCLUDEDTID (RPH_0010) Clinical Trial Results Image Library Entry1-nMThe image library contains relevant attributes of relevant images, e.g., the Pixel Spacing in an image to recomputed distances from coordinates without having to open the images, or the modality of the images to describe what type of image measurements were made from, etc.7>CONTAINSCONTAINEREV (RP-100702, 99RPH, General Lesion Observations)1MCShall not be present if Row 15 is present.I.e., initial or if Level 2 adjudication.8>>CONTAINSINCLUDEDTID(RPH_0006b) General Lesion Observations 1M9>CONTAINSCONTAINEREV (RP-100023, 99RPH, Reading Sub-task)1-nMInformation from multiple sub-tasks may be encoded in a single instance; the most recently created SR will successively accumulate information from previous sub-tasks, and reference previous versions as predecessors.10>>HAS OBS CONTEXTINCLUDEDTID(RPH_0003) Reading Session and Task Context1MThe multiple sub-tasks that have lead to the cumulative state encoded in this SR instance may have been performed in one task or multiple tasks.11>CONTAINSCONTAINEREV (RP-100024, 99RPH, Time Point)1-nMThere is always at least one time point.12>>HAS OBS CONTEXTINCLUDEDTID(RPH_0004) Time Point Context 1M13>>CONTAINSINCLUDEDTID(RPH_0005) Time Point Observations 1MCShall not be present if Row 15 is present.I.e., initial or if Level 2 adjudication14>>CONTAINSINCLUDEDTID(RPH_0006) Time Point Lesion Observations 1MCShall not be present if Row 15 is present.I.e., initial or if Level 2 adjudication.15>>CONTAINSINCLUDEDTID(RPH_0005b) Adjudication Observations 1MCRequired if EV (RP-100212, 99RPH, Worklist Task Level) in TID RPH_0003 is (RP-100214, 99RPH, Perform Comparision). Shall not be present otherwise.I.e., if Level 1 adjudication.16>CONTAINSCODEEV(RP-100074, 99RPH, Signature meaning)1MCRequired if Verification Flag (0040,A493) is VERIFIED. Shall not be present otherwise.DCID RPH_7015 Signature Meanings TID RPH_0002a Person Observer Identifying Attributes This template contains identifying and descriptive attributes of persons that are observers. It extends the standard TID 1003 to include additional information specific to clinical trials. TID RPH_0002a PERSON OBSERVER IDENTIFYING ATTRIBUTES Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1HAS OBS CONTEXTPNAMEEV (121008,DCM, Person Observer Name)1MHuman readable names, like Smith^Joan2HAS OBS CONTEXTTEXTEV (RP-100006, 99RPH, Person Observers Login Name)1MAdditional to TID 1003. E.g. jsmith.3HAS OBS CONTEXTTEXTEV (121009,DCM, Person Observers Organization Name) 1MShall be equal to Institution Name (0008,0080) of the General Equipment ModuleIs Type U in TID 1003. Also, in TID 1003 the constraint is defaults to rather than shall be equal to.4HAS OBS CONTEXTCODEEV (121011,DCM, Person Observers Role in this Procedure)1MDCID(RPH_7001) Clinical Trial Performing RolesIs Type U in TID 1003. RPH_7001 overrides the BCID 7453 in TID 1003.5HAS OBS CONTEXTTEXTEV (RP-100007, 99RPH, Identifier within Person Observers Role)1MTypically 1 or 2, or A or B, to designate individual within the role defined by Row 4 (which might be a code meaning Reader). TID RPH_0002b Device Observer Identifying Attributes This template contains identifying and descriptive attributes of the device used during the read. It replaces the standard TID 1004, in order to avoid repeating information already present in the General Equipment Module, which is specified later in this document. It includes additional information specific to semi-automated and automated quantitative measurements performed in clinical trials. Note: EV (121012,DCM, Device Observer UID) is specified in TID 1004 (as mandatory) but is not useful in the our context. TID RPH_0002b DEVICE OBSERVER IDENTIFYING ATTRIBUTES Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1HAS OBS CONTEXTTEXTEV (RP-100084, 99RPH, Application Name)1-nUAn application might be a plug-in to a host. The description and version of the host would be in the General Equipment Module.2>HAS PROPERTIESTEXTEV (RP-100083, 99RPH, Version)1M3HAS OBS CONTEXTTEXTEV (111001, DCM, Algorithm Name)1-nU4>HAS PROPERTIESTEXTEV (RP-100083, 99RPH, Version)1MThere is a specific DICOM code (111003, DCM, Algorithm Version) used in Mammo CAD, but for consistency with the other items in this template, a generic version code is used.5>HAS PROPERTIESCODEEV (RP-100085, 99RPH, Algorithm Type)1MDCID (RPH_7016) Algorithm Type6>HAS PROPERTIESTEXTEV (RP-100926, 99RPH, Algorithm UID)1MA TEXT rather than UIDREF is used, since this may not be a DICOM format UID. Will be different for different versions of the same name. May be referenced from a particular application of this algorithm. Shall be different if the version is different for the same algorithm name.7>HAS PROPERTIESTEXTEV (111002, DCM, Algorithm Parameters)1-nUSuch parameters could be stuffed in some unstructured or proprietary structured way into such a text item, or (preferably) listed as extensible subordinate text, code or numeric content items in a structured manner (e.g., specific thresholds used for segmentation).8HAS OBS CONTEXTTEXTEV (RP-100086, 99RPH, Business Rule Set Name)1-nMCRequired if business rules were used.This is a name for a set of business rules used during the creation of this SR instance.Multiple, since for example, there may be a pan-CoreLab Partners set, and a protocol-specific set, each with a different name and version.9>HAS PROPERTIESTEXTEV (RP-100083, 99RPH, Version)1M TID RPH_0002c Clinical Trial Protocol Context This template contains identifying and descriptive attributes of the protocol that is being read. It conveys information specific to the protocol that is not included in the top level DICOM dataset (e.g., in the Clinical Trial Subject Modules). TID RPH_0002c CLINICAL TRIAL PROTOCOL CONTEXT Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1HAS OBS CONTEXTTEXTEV (RP-101100, 99RPH, Protocol Name)1MCRequired if present with a value in the worklist.Set to the value of ProtocolName in the worklist.2HAS OBS CONTEXTTEXTEV (RP-101101, 99RPH, Protocol UID)1MCRequired if present with a value in the worklist.Set to the value of ProtocolUID in the worklist. Is not a DICOM UID, hence the TEXT VT.3HAS OBS CONTEXTTEXTEV (RP-101109, 99RPH, Protocol Number)1MCRequired if present with a value in the worklist.Set to the value of ProtocolNumber in the worklist. TID RPH_0002d Subject Context This template contains identifying and descriptive attributes of the subject of the read. It replaces the standard TID 1006, in order to convey information specific to the subject that is relavant to a clinical trial and not included in the top level DICOM dataset (e.g., in the General Patient and Clinical Trial Subject Modules). TID RPH_0002d SUBJECT CONTEXT Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1HAS OBS CONTEXTTEXTEV (RP-101102, 99RPH, Site UID)1MCRequired if present with a value in the worklist.Set to the value of Site UID in the worklist. Is not a DICOM UID, hence the TEXT VT.2HAS OBS CONTEXTTEXTEV (RP-101103, 99RPH, Subject UID)1MCRequired if present with a value in the worklist.Set to the value of Subject UID in the worklist. Is not a DICOM UID, hence the TEXT VT.3HAS OBS CONTEXTDATEEV (RP-101104, 99RPH, Enrollment Date)1MCRequired if present with a value in the worklist.Set to the value of Enrollment Date in the worklist.4HAS OBS CONTEXTDATEEV (RP-101105, 99RPH, Randomization Date)1MCRequired if present with a value in the worklist.Set to the value of Randomization Date in the worklist.5HAS OBS CONTEXTDATEEV (RP-101106, 99RPH, First Dose Date)1MCRequired if present with a value in the worklist.Set to the value of First Dose Date in the worklist.6HAS OBS CONTEXTDATEEV (RP-101107, 99RPH, End of Treatment Date)1MCRequired if present with a value in the worklist.Set to the value of End of Treatment Date in the worklist.7HAS OBS CONTEXTDATEEV (RP-101108, 99RPH, Termination Date)1MCRequired if present with a value in the worklist.Set to the value of Termination Date in the worklist. TID RPH_0003 Reading Session and Task Context This template contains identifying and descriptive attributes of the reading session and the reading task that result in clinical trial results. TID RPH_0003 READING SESSION AND TASK CONTEXT Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1HAS OBS CONTEXTTEXTEV (RP-100008, 99RPH, Worklist Task Name)1M2>HAS OBS CONTEXTUIDREFEV (RP-100081, 99RPH, Worklist Task UID)1MAllows results generated from one sub-task to be related to another sub-task within the same work list task, or to be referenced from elsewhere, though no such reference mechanism is currently defined.3>HAS OBS CONTEXTTEXTEV (RP-100010, 99RPH, Worklist Task Version)1UWill be different if the content of a task is edited (e.g., in response to a change in the read request).4>HAS OBS CONTEXTTEXTEV (RP-100011, 99RPH, Worklist Task Description)1U5>HAS OBS CONTEXTCODEEV (RP-100212, 99RPH, Worklist Task Level)1MDCID RPH_7003b Clinical Trial Worklist Task Levels6>HAS OBS CONTEXTCODEEV (RP-100210, 99RPH, Worklist Task Type)1MDCID RPH_7002 Clinical Trial Worklist Task Type 7>HAS OBS CONTEXTCODEEV (RP-100211, 99RPH, Worklist Task Category)1MDCID RPH_7003 Clinical Trial Worklist Task Category8>HAS OBS CONTEXTCODEEV (RP-100232, 99RPH, Worklist Task Repeat Type)1MCRequired if the task is a repeat task. Shall not be present otherwise.DCID RPH_7003c Clinical Trial Worklist Task Repeat Types9>HAS OBS CONTEXTCODEEV (RP-100233, 99RPH, Worklist Task Variability Type)1MCRequired if the task is a variability task. Shall not be present otherwise.DCID RPH_7003d Clinical Trial Worklist Task Variability Types10>HAS OBS CONTEXTTEXTEV (RP-100009, 99RPH, Worklist Sub-task Name)1M11>>HAS OBS CONTEXTUIDREFEV (RP-100082, 99RPH, Worklist Sub-task UID)1MMay be referenced from audit trail entries.12>>HAS OBS CONTEXTDATETIMEEV (RP-100924, 99RPH, Worklist Sub-task Start DateTime)1MDoes not change once started, even if the sub-task is closed as incomplete and re-opened one or more times before completion.13>>HAS OBS CONTEXTDATETIMEEV (RP-100925, 99RPH, Worklist Sub-task Closed DateTime)1MWhether completed or not; will be the same as Verification DateTime (0040,A030) if closed as complete and signed. TID RPH_0004 Time Point Context This template contains identifying and descriptive attributes of a time point in clinical trial results. TID RPH_0004 TIME POINT CONTEXT Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1HAS OBS CONTEXTTEXTEV (RP-100018, 99RPH, Subject Time Point Unique Identifier)1MValue shall be the same as encoded in the Clinical Trial Time Point ID (0012,0050) attribute in the Clinical Trial Study Module of the header.2HAS OBS CONTEXTTEXTEV (RP-100017, 99RPH, Protocol Time Point Unique Identifier)1M3HAS OBS CONTEXTTEXTEV (RP-100019, 99RPH, Time Point Name)1MValue shall be the same as encoded in the Clinical Trial Time Point Description (0012,0051) in the Clinical Trial Study Module of the header. This will be a generated text value, usually sequential in form, based on the days of enrollment and Timepoint Type provided.4HAS OBS CONTEXTTEXTEV (RP-100550, 99RPH, Time Point Sponsor Name)1M4aHAS OBS CONTEXTTEXTEV (RP-100551, 99RPH, Time Point Type)1MThe values known are scheduled and unscheduled, but there is no need to code this, because it replicates the flag in Row 5.4bHAS OBS CONTEXTNUMEV (RP-100552, 99RPH, Days from enrollment)1MUnits EV (d, UCUM, Days)On-study baseline will have a HAS OBS CONTEXT value of 0 days; pre-study (eligibility) may have negative days.4cHAS OBS CONTEXTNUMEV (RP-100553, 99RPH, Time Point Order)1MUnits EV ({order}, UCUM, order)Usually derived from days from enrollment in a sequential read; the first time point will have an order value of 0 and increase by 1 for successive time points.5HAS OBS CONTEXTCODEEV (RP-100021, 99RPH, Time Point Unscheduled)1MDCID (RPH_7230) Yes-No Only6HAS OBS CONTEXTCODEEV (RP-100022, 99RPH, Time Point Baseline)1MDCID (RPH_7230) Yes-No Only7HAS OBS CONTEXTCODEEV (RP-100090, 99RPH, Completed)1MDCID (RPH_7230) Yes-No OnlyImplies that any subsequent changes will require permission, change reasons and an audit trail entry, and that any lesions added to this time point will be additional rather than initial.8HAS OBS CONTEXTTEXTEV (121065, DCM, Procedure Description)1-nMCRequired if any images were available for review for this time point.Shall be derived from the Study Description (0008,1030) of the General Study Module in the images.Cardinality of >= 1 assumes that there will always be at least one Study. The UIDREF Study Instance UID would be a logical choice for the parent of each study-related entry, but cannot be used due to constraints on Comprehensive SR relationships between source and target content items; use the Study (Procedure) Description instead.9>HAS PROPERTIES UIDREFEV (110180, DCM, Study Instance UID)1MShall be derived from the Study InstanceUID (0020,000D) of the General Study Module in the images.10>HAS PROPERTIESCODEEV (121139, DCM, Modality)1-nMDCID (29) Modalities Shall be derived from the Modality (0008,0060) value(s) of the General Series Module in the images.Note that this is a code, not a string, and so the string value from the Modality attribute in the DICOM image (e.g., CT) needs to be mapped to the proper code from DICOM Part 16 (e.g., (CT, DCM, Computed Tomography)). The cardinality is >= 1, since there may be more than one modality in a DICOM study (e.g., a CT and a PET in the one study). There is always at least one value known.10a>HAS PROPERTIESCODEEV (121058, DCM, Procedure reported)1MCShall be present if supplied in the worklist.DCID RPH_7080 Procedures Reported If present, shall be copied from the ProcedureReported element supplied in the worklist.This is code describing some sub-type of modality or procedure, e.g., a MUGA or Sestamibi or Ventilation/Perfusion type of NM scan. Typically absent, for example for ordinary body CT.11>HAS PROPERTIESDATEEV (111060, DCM, Study Date)1MShall be derived from the Study Date (0008,0020) value of the General Study Module in the images.The Study Date is mandatory because it should always be known. Note that date of response assessment is specifically encoded at the time point observation lesion level.12>HAS PROPERTIESTIMEEV (111061, DCM, Study Time)1UIf present, shall be derived from the Study Time (0008,0030) value of the General Study Module in the images.The Study Time is optional because it may not always be known, and is generally less important to recipients.13>HAS PROPERTIESCODEEV (RID12236, RADLEX, Anatomic Region Covered)1MDCID RPH_7007 Anatomic Regions for Radiology Procedures, or DCID RPH_7007b Anatomic Regions for External Photography Procedures Shall be copied from the BodyPart element code supplied in the worklist, if present, otherwise may be derived from the Anatomic Region Sequence (0008,2218) code value or Body Part Examined (0018,0015) string value in the images.This corresponds to the Body Part for the procedure; it is coded and not plain text. May be a combined anatomic region, e,g, if CT chest, abdomen and pelvis studies have been combined.13b>>HAS CONCEPT MODCODEEV (G-C171, SRT, Laterality)1MDCID (244) Laterality Shall be copied from the Laterality element code supplied in the worklist, if present, otherwise may be derived from the Laterality (0020,0060), Image Laterality (0020,0062) or Frame Laterality (0020, 9072) value in the images.The value set contains codes for right, left, both and unilateral (unpaired), hence is always required for coded anatomic regions14>HAS PROPERTIESUIDREFEV (RP-100904, 99RPH, Exam Identifier)1-nMCShall be present if supplied in the worklist.15>HAS PROPERTIESNUMEV (RID12405, RADLEX, Reconstruction Interval)1MCShall be present if supplied in the worklist.EV (mm, UCUM, millimeters)Represents the nominal reconstruction interval for the procedure (i.e., at the study level as supplied by the worklist). May differ from the actual RI computed for an image with respect to its neighbors and recorded in the image library. May be absent in the worklist if multiple studies with different RI are combined into one load not sent rather than choosing (a possibly incorrect) one.16>HAS PROPERTIESNUMEV (15074-8, LN, Blood Glucose)1MCShall be present if supplied in the worklist.EV (mmol/l, UCUM, mmol/l)May be supplied for PET procedures. There is actually a separate code in SNOMED for blood glucose via glucometer, as opposed to this more generic code, as well as a code for plasma glucose, but this choice is sufficient.17>HAS PROPERTIESNUMEV (RP-100900, 99RPH, PET Radionuclide Incubation Time)1MCShall be present if supplied in the worklist.EV (min, UCUM, min)May be supplied for PET procedures . This value may differ from the value computed from the attributes in the PET image headers, if the site records this manually and/or accounts for other factors than are entered at or supported by the modality console. TID RPH_0005 Time Point Observations This template contains observations made about a time point in clinical trial results. TID RPH_0005 TIME POINT OBSERVATIONS Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINSCONTAINEREV (RP-100073, 99RPH, Time Point Observation)1-nU2>CONTAINSUIDREFEV(RP-100401, 99RPH, Observation UID)1M3>CONTAINSCODEDCID (RPH_7710) Baseline Time Point Observation Types With Yes-No Answers 1UCXOR Row 4, 5 and 6 and RPH_0004 Row 6 (RP-100022, 99RPH, Time Point Baseline) is (R-0038D,SRT, Yes).DCID (RPH_7230) Yes-No OnlyMay be provided to categorize a specific type of observation, e.g., an observation of a fluid collection. 4>CONTAINSCODEDCID (RPH_7711) Post-Baseline Time Point Observation Types With Yes-No Answers1UCXOR Row 3, 5 and 6 and RPH_0004 Row 6 (RP-100022, 99RPH, Time Point Baseline) is (R-00339, SRT, No).DCID (RPH_7230) Yes-No OnlyMay be provided to categorize a specific type of observation, e.g., an observation of pseudo-progression.5>CONTAINSCODEDCID (RPH_7712) Post-Baseline Time Point Observation Types With Yes-No-UE Answers1UCXOR Row 3, 4 and 6 and RPH_0004 Row 6 (RP-100022, 99RPH, Time Point Baseline) is (R-00339, SRT, No).DCID (RPH_7231) Yes-No-UE6>CONTAINSNUMDCID (RPH_7031) Time Point Numeric Observations1UCXOR Row 3, 4 and 5DCID (RPH_7032) Time Point Numeric Observation UnitsThe units need to be appropriate to the type of observation (e.g., mm for SLD, mm2 for SPD, % for changes from baseline or nadir). There is no direct reference to the time point lesion observations that aggregate measurements may have been computed from. If a numeric value is not available, then the Numeric Qualifier attribute within the NUM content item shall be used to convey: unable to evaluate (UE), for which (114011, DCM, Value indeterminate) shall be used not applicable (NA), for which (114007, DCM, Measurement not attempted) shall be used.7>CONTAINSTEXTEV(121106, DCM, Comment)1UIf Rows 3, 4, 5 and 6 are all absent, the type is unspecified and any comment present is not categorized. Will be absent if a comment was present but was removed by the user (and an audit trail entry made), since zero-length (empty) values are not permitted for TEXT content items.8>HAS OBS CONTEXTINCLUDEDTID(RPH_0020) Audit Trail Entry Template1M$ChangeReasons = DCID RPH_7014 Time Point Change Reasons $AdditionReasons = DCID RPH_7014c Time Point Observation Addition ReasonsThis template includes a completed flag, which is with respect to the individual observation about the time point, and distinct from the completed flag for the entire time point (in RPH_0004 Timepoint Context). TID RPH_0005b Adjudication Observations This template contains observations made about comparison between two or more performers clinical trial results (i.e., adjudication). This template is included within a parent content item that describes a specific time point, but whether or not it applies to just that time point, or all previous time points as well, is explicitly called out, TID RPH_0005b ADJUDICATION OBSERVATIONS Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINEREV (RP-100280, 99RPH, Adjudication Observation)1M2>CONTAINSUIDREFEV(RP-100401, 99RPH, Observation UID)1M3>CONTAINSCODEEV (121011,DCM, Person Observers Role in this Procedure)1MDCID(RPH_7001b) Clinical Trial Adjudicated RolesThis is the role of the observers whose work is being adjudicated, e.g., a code for reader. This is NOT the role of adjudicator themselves, which for this SR instance is encoded in TID RPH_0002a Person Observer Identifying Attributes. This role is factored out from the accepted and rejected observers lists in this template, since they must all have the same role.4>CONTAINSCONTAINEREV (RP-100281, 99RPH, Observers Accepted)1MCRequired if an observer was accepted.Will be absent if no observer was accepted.5>>CONTAINSTEXTEV (RP-100007, 99RPH, Identifier within Person Observers Role)1MTypically 1 or 2, or A or B, to designate individual within the role defined by Row 4 (which might be a code meaning Reader).E.g. just 1 (and not reader 1). This identifies which observer, if any, was chosen from the choices available (i.e., their results were accepted by the adjudicator). Only the role and the identifier within the role is provided; it is assumed that it is not necessary also include the persons full name or their login in.6>CONTAINSCONTAINEREV (RP-100282, 99RPH, Observers Rejected)1M7>>CONTAINSTEXTEV (RP-100007, 99RPH, Identifier within Person Observers Role)1-nMThis identifies which observer(s) were not chosen from the choices available (i.e., their results were rejected by the adjudicator, in favor of the results of the observer described in Row 3). May be multiple, if there were more than two observers, or if no observers were chosen; results being adjudicated.8>CONTAINSCODEEV (RP-100283, 99RPH, Reason for Choice)1MCRequired if Row 8b (RP-100286, 99RPH, Image Quality Issues Contribute to Discordance) is (R-00339, SRT, No) and Row 8a RP-100284, Reason for Discordance) value is not justifiable.DCID RPH_7050a Adjudication Choice ReasonsImage quality may be the only reason, or there may be (one) additional reason when the reson for discordance is not justifiable (as defined in DCID RPH_7050b Adjudication Discordance Reason.8a>CONTAINSCODEEV (RP-100284, 99RPH, Reason for Discordance)1MDCID RPH_7050b Adjudication Discordance Reason8b>CONTAINSCODEEV (RP-100286, 99RPH, Image Quality Issues Contribute to Discordance)1MDCID (RPH_7230) Yes-No Only9>CONTAINSTEXTEV(121106, DCM, Comment)1U10>CONTAINSCODEEV(RP-100277, 99RPH, Observation Scope)1MCID RPH_7052 Adjudication Observation ScopeWhether or not the adjudication is performed and recorded one time point at a time (sequential) or at a specific time point with reference to all preceding time points.11>HAS OBS CONTEXTINCLUDEDTID(RPH_0020) Audit Trail Entry Template1M$ChangeReasons = DCID RPH_7014a Adjudication Change Reasons TID RPH_0006 Time Point Lesion Observations This template contains observations made about lesions in clinical trial results at a specific time point (as opposed to general observations about lesions that are not time point specific see TID RPH_0006b General Lesion Observations). It also includes lesions that are created for the purpose of calibrating scanned film or other secondary capture images. TID RPH_0006 TIMEPOINT LESION OBSERVATIONS Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINSCONTAINEREV (RP-100025, 99RPH, Lesion)1-nU2>CONTAINSUIDREFEV (112040, DCM, Tracking Unique Identifier)1MThe commonality of this UID with the same UID in the TID RPH_0006b General Lesion Observations template allows access to common information about a lesion that spans time points, specifically such things as its label (Tracing Identifier), type, site, etc., hence these are NOT repeated here.3>CONTAINSCODEEV (RP-100320, 99RPH, Calibration)1MDCID (RPH_7230) Yes-No OnlyWhether or not this lesion was created for the purpose of calibrating scanned film or other secondary capture images. Calibrations are managed as lesions (and not just measurement objects) in order to capture a UID, completion status and change reasons when recalibration takes place.4>CONTAINSUIDREFEV (RP-100028, 99RPH, Predecessor Lesion Tracking Unique Identifier)1-nMCRequired if this lesion is related to one or more lesions on a previous time point that has split or merged at this time point. Shall be a single value if a lesion has split at this time point, in which case the parent lesion (before splitting) is referenced; shall be multiple values referencing all the lesions on the previous time point that merged. Shall not be present if Row 3 (RP-100320, 99RPH, Calibration) is (R-0038D,SRT, Yes).Has the values of Row 2 EV (112040, DCM, Tracking Unique Identifier) for each of the predecessor lesionsThough once it has been observed, a relationship to predecessors could be construed as a common information that could be encoded in TID RPH_0006b General Lesion Observations; however, it is intended to capture on which time point the decision that predecessor relationship exists, and so it is encoded on per-time point basis in this template. The referenced predecessors, by definition, will not have observations in this time point, and on subsequent time points, there will be no references to predecessors present.5>CONTAINSTEXTEV (121106, DCM, Comment)1ULesion comments at the time point level are optional, and there may only be one of them.7>CONTAINSINCLUDEDTID(RPH_0007) Measurement Objects1MCRequired if Row 11 (RP-100042, 99RPH, Unable to evaluate lesion) is (R-00339,SRT, No). May be present otherwise.$Calibration = Row 3 valueSee Note 1.8>CONTAINSINCLUDEDTID(RPH_0007) Measurement Objects1-nUCShall be present otherwise only if Row 11 (RP-100042, 99RPH, Unable to evaluate lesion) is (R-00339,SRT, No) and Row 3 RP-100320, 99RPH, Calibration) is (R-00339,SRT, No).$Calibration = EV (R-00339,SRT, No)This describes additional regions and measurements about the lesion; see Notes 1 and 2.9>CONTAINSCODEEV(RID11510, RADLEX, Therapeutic Response)1MCRequired if EV (RP-100022, 99RPH, Time Point Baseline) of the enclosing time point content item is (R-00339,SRT, No) and Row 4 EV (RP-100026, 99RPH, Lesion Type) of RPH_0006b for the same Tracking Unique Identifier is (RP-100030, 99RPH, Non-target lesion) and Row 6 is (R-00339,SRT, No) and Row 9b is absent. Shall not be present otherwise.DCID RPH_7010 Non-Target Lesion Response or if the modality of the image on which the lesion is defined is PET DCID RPH_7010b PET Target Lesion Qualitative ResponseNote that N/A (not applicable) has NOT been included in this list; note also that UE is also not included, since this is factored out into a yes/no flag, since the same concept is used for both target and non-target lesions. RPH_7010b defines PMD, SMD, PMR and CMR9b>CONTAINSCODEEV(RP-100901, 99RPH, Qualitative Assessment)1UDCID RPH_7010c PET Lesion Qualitative Assessment.May be present for certain types of PET protocols, for example.11>CONTAINSCODEEV(RP-100042, 99RPH, Unable to evaluate lesion)1MCRequired if Row 3 RP-100320, 99RPH, Calibration) is (R-00339,SRT, No). Shall not be present otherwise.DCID (RPH_7230) Yes-No OnlyShould be yes when either the target/new UE checkbox is set, or the non-target response drop down is selected as UE. This is always present, even if baseline (except for missing images or calibrations); for baseline where measurements (quantitative assessments) are present, or where there is no therapeutic assessment (never is at baseline), it shall always be No; however, when qualitative assessments are being made (e.g., for PET), this flag may sometimes be Yes at baseline.12>CONTAINSCODEEV(RP-100043, 99RPH, Reason unable to evaluate)1MCRequired if Row11 EV(RP-100042, 99RPH, Unable to evaluate lesion) is (R-0038D,SRT, Yes). Shall not be present otherwise.DCID RPH_7011 Reasons Unable to Evaluate LesionCorresponds to the lesion UE choices for target, new and non-target lesions.13>CONTAINSCODEEV(RP-100053, 99RPH, Unable to measure lesion)1MCRequired if EV (RP-100022, 99RPH, Time Point Baseline) of the enclosing time point content item is (R-00339,SRT, No) and Row 4 EV (RP-100026, 99RPH, Lesion Type) of RPH_0006b for the same Tracking Unique Identifier is NOT (RP-100030, 99RPH, Non-target lesion) and Row 11 EV(RP-100043, 99RPH, Unable to evaluate lesion) is (R-00339,SRT, No) and Row 9b EV(RP-100901, 99RPH, Qualitative Assessment) is absent and Row 6 is (R-00339,SRT, No). Shall not be present otherwise.DCID (RPH_7230) Yes-No Only14>CONTAINSCODEEV(RP-100054, 99RPH, Reason unable to measure)1MCRequired if Row 13 EV(RP-100053, 99RPH, Unable to measure lesion) is (R-0038D,SRT, Yes) and Row 14b EV(RP-100285, 99RPH, Unequivocal Progression) is not (R-0038D,SRT, Yes). Shall not be present otherwise.DCID RPH_7012 Reasons Unable to Measure Target Lesion if lesion is a target lesion DCID RPH_7012b Reasons Unable to Measure New Lesion if lesion is a new lesion Corresponds to the target/new lesion radio buttons, other than UE, which is factored out separately to be common with non-target lesions, other than merged with which is handled through referenced links, and other than unequivocal progression, which is a separate content item.14b>CONTAINSCODEEV (RP-100285, 99RPH, Unequivocal Progression)UCMay only be present for non-target lesion and Row 13 EV(RP-100053, 99RPH, Unable to measure lesion) is (R-0038D,SRT, Yes).DCID (RPH_7230) Yes-No OnlyUsed to indicate unequivocal progression when measurement is required but unable to measure.15>HAS OBS CONTEXTINCLUDEDTID(RPH_0020) Audit Trail Entry Template1MIf Row 3 (RP-100320, 99RPH, Calibration) is (R-00339,SRT, No), then $ChangeReasons = DCID RPH_7013 Lesion Change Reasons and $AdditionReasons = DCID RPH_7013b Lesion Addition Reasons If Row 3 (RP-100320, 99RPH, Calibration) is (R-0038D,SRT, Yes), then $ChangeReasons = DCID RPH_7013c Calibration Change Reasons and $AdditionReasons shall not be used.Though this template is included only once, it may contain multiple modification entries within it, since multiple successive changes may have been performed on successive sub-tasks, or both a recalibration and another type of modification may have been made in the same sub-task. When a recalibration is performed, not only does the calibration lesion have an audit trail entry, but all lesions affected by it also (DCID RPH_7013 Lesion Change Reasons includes (RP-100351,99RPH,Recalibration)). Notes: 1. A Lesion may have multiple additional regions or measurements, for example, to describe the end points of a RECIST-style linear distance measurement that has been made (manually or automatically) on a lesion that has been defined spatially by other means, such as by 2D iso-contours that were generated from a 3D segmentation. 2. The presence of multiple regions or measurements for a Lesion may be because multiple (independent) observations about the lesion have been made (e.g., different kinds of lengths, volumes + manual lengths, etc.), or because there are related separate regions and measurements (e.g., a tumor region and a background region to allow computation of tumor to background ratio using RPH_0007d Measurements Derived From Other Measurements). TID RPH_0006b General Lesion Observations This template contains observations made about lesions in clinical trial results that are not specific to time point (as opposed to time point specific observations about lesions- see TID RPH_0006 Time Point Lesion Observations). TID RPH_0006b GENERAL LESION OBSERVATIONS Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINSCONTAINEREV (RP-100025, 99RPH, Lesion)1-nU2>CONTAINSUIDREFEV (112040, DCM, Tracking Unique Identifier)1MA globally unique identifier for all instances of this particular lesion in this particular subject made by this particular reader role that is the same for instances of the lesion in different SR SOP Instances.Variously referred to in the model and other documents as Lesion UID or Link UID.3>CONTAINSTEXTEV (112039,DCM, Tracking Identifier)1MShall be the same for all instances of the same lesion with the same Tracking Unique Identifier.Tracking Identifier is from DICOM CAD, e.g., TID 4108, and is used together with Tracking Unique Identifier. The definition is A text label used for tracking a finding or feature, potentially across multiple reporting objects, over time. This label shall be unique within the domain in which it is used. Arguably, EV (121151, DCM, Lesion Identifier) could be used here instead, as in DICOM Procedure Logs, e.g., TID 3105. The definition is Identification of a Lesion observed during an imaging procedure. Has a value corresponding to the lesion label base as used in CoreLab Partners, e.g., 001. Note that split lesions are regarded as separate lesions entirely (and not a suffix qualifying the parent lesion); likewise merged lesions.4>CONTAINSCODEEV (RP-100026, 99RPH, Lesion Type)1MDCID RPH_7004 Lesion TypeWill have a value of (RP-100320, 99RPH, Calibration) if a calibration.5b>CONTAINSCODEEV (RP-100036, 99RPH, Reconstruction Interval Unknown But Sufficient For Lesion Selection)1MCRequired if is Row 4 EV (RP-100026, 99RPH, Lesion Type) is (RP-100029, 99RPH, Target lesion) and Row 4 EV (RID12405, RADLEX, Reconstruction Interval) is not present in TID RPH_0010 Clinical Trial Results Image Library Entry for the image referenced by the baseline MO defining this lesion.DCID (RPH_7230) Yes-No OnlyUsed to record that user has overriden rules related to minimum lesion size relative to reconstruction interval. 6>CONTAINSCODEEV (G-C0E3, SRT, Finding Site)1MCRequired if is Row 4 EV (RP-100026, 99RPH, Lesion Type) is not (RP-100320, 99RPH, Calibration).BCID RPH_7006 Anatomic Sites for LesionsThe finding site is what users refer to as the anatomic site or anatomic location. Does NOT contain laterality, which is always separately encoded as a modifier (see Row 6b).6b>CONTAINSCODEEV (G-C171, SRT, Laterality)1MCRequired if is Row 4 EV (RP-100026, 99RPH, Lesion Type) is not (RP-100320, 99RPH, Calibration).DCID (244) LateralityThe value set contains codes for right, left, both and unilateral (unpaired), hence is always required for coded finding sites. Not nested as a child as a concept modifier, in order to make accessible as gFindings column.6c>CONTAINSCODEEV (G-C2CE, SRT, Multiplicity)1MCRequired if Row 6 value is a lymph node site (i.e., in CID RPH_7006b)DCID (RPH_7702) MultiplicityMay affect the rules for what axis to measure for some response criteria (e.g., short rather than long axis for RECIST 1.1 single lymph nodes). Not nested as a child as a concept modifier, in order to make accessible as gFindings column.10>HAS OBS CONTEXTINCLUDEDTID(RPH_0020) Audit Trail Entry Template1M$ChangeReasons = DCID RPH_7013 Lesion Change Reasons $AdditionReasons = DCID RPH_7013b Lesion Addition Reasons Notes: TID RPH_0007 Measurement Objects This template contains regions and measurements and annotations made on images for the purpose of defining or describing lesions in clinical trial results, referred to collectively as measurement objects. It includes regions or measurements defined by 2D (image-relative) spatial coordinates, regions defined by 3D geometric objects, and regions defined by rasterized bitmaps of 3D locations encoded as references to single-segment multi-frame Segmentation Storage SOP Instances, with accompanying measurements. At this time no explicit 3D spatial coordinate mechanism is defined. Measurement objects do NOT include the RPH_0020 Audit Trail Entry Template, since any change to a measurement object for a lesion (including changes to values as a consequence of recalibration), or addition of a measurement object to a lesion, will be recorded as an edit to the Timepoint Lesion Observations as a whole. The person and date and time of creation and last modification are persisted however. TID RPH_0007 Parameters Parameter NameParameter Usage$CalibrationWhether or not the Measurement Object is a calibration. DCID (RPH_7230) Yes-No Only. Used to constrain the measurement object type. TID RPH_0007 Measurement Objects Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINSCONTAINEREV(RP-100502, 99RPH, Measurement Object)1M1a>CONTAINSUIDREFEV(RP-100403, 99RPH, Measurement Object UID)1MThis UID is used as the reference for the source of other measurements derived from this measurement. It is also used when an application propagates a measurement object from one time point to a subsequent time point, not to be reused, since a new measurement object on a new time point will have a new UID, but to be able to retrieve characteristics of the predecessor measurement object, or the lesion that it is a child of.1b>CONTAINSCOMPOSITEEV(RP-100700, 99RPH, Registration Used)1-nMCRequired if frames of reference were registered manually or automatically at the time that the measurement object was created or edited.The type of registration (e.g. manual or automatic; see PS 3.16 CID 7100 RCS Registration Method Type) and whether or not the registration is between frames of reference or defined sub-sets of images is encoded in the referenced registration instance itself, and not replicated here. Whether the registration is rigid or deformable can be determined from the Referenced SOP Class in the COMPOSITE content item.During the course of reading a sub-task, multiple potentially different manual and automatic registrations may be performed. This content item references the registration instances active and relevant to this measurement object.1c>>HAS OBS CONTEXTTEXTEV (RP-100926, 99RPH, Algorithm UID)1MCRequired if the registration was not established manually.2b> CONTAINSCODEEV (121139, DCM, Modality)1MCRequired if Row 3 (RP-100503, 99RPH, Measurement Object Type) is not (RP-100111, 99RPH, Measurements Derived From Other Measurements).DCID (29) ModalitiesShall be taken from the Modality element in the DICOM image(s) to which this measurement object applies.2c>CONTAINSDATEEV (RP-100600, 99RPH, Acquisition Date)1MCXOR row 2dShall be the value of Acquisition Date (0008,0022), if present, in the image(s) to which the measurement object applies. If Acquisition Date (0008,0022) is not present in the image, then the date extracted from Acquisition DateTime (0008,002A), or if absent, the value of Content Date (0008,0023), or if absent, the value of Series Date (0008,0021), or if absent the value of Study Date (0008,0020), shall be used. If more than one image obtained on different dates is used, then the earliest date shall be used.Used to establish date of response or progression. The most reliable date related to the date on which the (primary) image was acquired is used here, for example to determine the exact date of response or progression.2d>CONTAINSTEXTEV (RP-100601, 99RPH, Acquisition Date Alias)1MCXOR row 2cWhen reader blinded to date; used to later reestablish the date to use for response or progression.3>CONTAINSCODEEV(RP-100503, 99RPH, Measurement Object Type)1MDCID (RPH_7601) Measurement Object Types, with the following constraints: If $Calibration = EV (R-00339,SRT, No), then may be one of the following: EV (RP-100103, 99RPH, Line Segment) (i.e., ruler) EV (RP-100104, 99RPH, Biorthogonal Line Segments) EV (RP-101016, 99RPH, Triorthogonal Line Segments) EV (RP-100105, 99RPH, Angle) EV(111041, DCM, Outline) EV(G-D705, SRT, Volume) EV (RP-100121, 99RPH, 3D Geometric Object) EV(RP-100106, 99RPH, Text Annotation) (RP-100111, 99RPH, Measurements Derived From Other Measurements) If $Calibration = EV (R-0038D,SRT, Yes), then may be only: EV (RP-100103, 99RPH, Line Segment) (i.e., ruler)The measurement object type itself is described by a separate (coded) content item rather than using the concept name of an SCOORD, since not all measurement objects can be defined by SCOORDs and some measurement objects are defined by multiple SCOORDs.4>CONTAINSINCLUDETID RPH_0007a Simple Measurements1MCRequired if Row 3 is (RP-100103, 99RPH, Line Segment) or EV (RP-100104, 99RPH, Biorthogonal Line Segments) or EV (RP-101016, 99RPH, Triorthogonal Line Segments) or EV (RP-100105, 99RPH, Angle)$MeasurementType = Row 3 value $Automation = CID RPH_7041Measurement objects that do not consist of closed 2D or 3D structures are defined not to have sub-regions.5>CONTAINSINCLUDETID RPH_0007b Sub-Regions and Measurements1MCRequired if Row 3 is (111041, DCM, Outline) or (G-D705, SRT, Volume) or (RP-100121, 99RPH, 3D Geometric Object).$RegionType = Row 3 valueMeasurement objects that are closed 2D or 3D structures are always defined to have at least one sub-region, even if there is only one.6>CONTAINSINCLUDETID RPH_0007c Text Annotation1MCRequired if Row 3 is (RP-100106, 99RPH, Text Annotation)7>CONTAINSINCLUDETID RPH_0007d Measurements Derived From Other Measurements1MCRequired if Row 3 is (RP-100111, 99RPH, Measurements Derived From Other Measurements)8>CONTAINSCODEEV (RP-100150, 99RPH, Discarded)1MDCID (RPH_7230) Yes-No OnlyWhether or not a measurement object is discarded also affects whether or not a lesion is discarded at a particular time point, since if all measurement objects are discarded, the lesion is explicitly discarded (there is no discarded flag at the time point lesion level or the general lesion level). If a lesion is actually discarded by discarding all measurement objects at a time point, then depending on the business rules, all measurement objects for that lesion on all time points may also need to be discarded. Discardng a measurement object for a lesion that has been completed will require a change reason be captured and encoded at the time point lesion level.9>HAS OBS CONTEXTDATETIMEEV(RP-100920, 99RPH, Observation Creation DateTime)1MThe full audit trail entry for RPH_0020 is not deemed to be necessary for individual measurement objects, but rather the creation and (last) modification time are sufficient for the findings navigator model to persist. These may be used to detect the need for audit trail entries at the lesion level.9a>HAS OBS CONTEXTTEXTEV (RP-100006, 99RPH, Person Observers Login Name)1MThe observer who created the observation. Is always explicit, and never assumed to be the creator of the current sub-task, since may have been created by a different observer in a previous sub-task.10>HAS OBS CONTEXTDATETIMEEV(RP-100921, 99RPH, Observation Modification DateTime)1MCRequired if measurement object has been modifiedOf the last modification (if modified more than once), e.g., when the size changes or there is a value change caused by recalibration 10a>HAS OBS CONTEXTTEXTEV (RP-100012, 99RPH, Last Modifying Person Observers Login Name)1MCRequired if measurement object has been modifiedThe observer who last modified the observation. Is always explicit, and never assumed to be the creator of the current sub-task, since may have been created by a different observer in a previous sub-task.11>CONTAINSNUMEV (RP-100140, 99RPH, Product of Short and Long Axes)1MCRequired if Row 3 (RP-100503, 99RPH, Measurement Object Type) is (RP-100104, 99RPH, Biorthogonal Line Segments) or (RP-101016, 99RPH, Triorthogonal Line Segments)Units EV (mm2, UCUM, mm2) or EV ({pixels}, UCUM, pixels). See Note 1.In this template, rather than within TID RPH_0007a Simple Measurement container, for additional configurable findings with measurement scope.12>CONTAINSNUMEV (RP-100141, 99RPH, Product of Short and Long and Normal Axes)1MCRequired if Row 3 (RP-100503, 99RPH, Measurement Object Type) is (RP-101016, 99RPH, Triorthogonal Line Segments)Units EV (mm3, UCUM, mm3) or EV ({pixels}, UCUM, pixels). See Note 1.In this template, rather than within TID RPH_0007a Simple Measurement container, for additional configurable findings with measurement scope. Note: 1. Products of distance will be measured in mm2 or mm3 if the image contains Pixel Spacing or Imager Pixel Spacing, as appropriate, or has been calibrated, or in pixels if uncalibrated and no spacing information is available (and not pixels squared or cubed). TID RPH_0007a Simple Measurements This template describes simple distance and angle measurements defined by 2D (image-relative) spatial coordinates. TID RPH_0007a Parameters Parameter NameParameter Usage$MeasurementTypeMay be one of EV (RP-100103, 99RPH, Line Segment) (i.e., ruler) EV (RP-100104, 99RPH, Biorthogonal Line Segments) EV (RP-101016, 99RPH, Triorthogonal Line Segments) EV (RP-100105, 99RPH, Angle)$AutomationDCID (RPH_7041) Measurement Automation TID RPH_0007a Simple Measurements Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINSCONTAINEREV (RP-101002, 99RPH, Simple Measurement)1M2>CONTAINSNUMDCID (RPH_7017) Single Line Segment Measurements1MCRequired if $MeasurementType is (RP-100103, 99RPH, Line Segment).Units EV (mm, UCUM, mm) or EV ({pixels}, UCUM, pixels). See Note 2.Unless the user overrides the choice, the default Concept Name should be (121206, DCM, Distance). If the purpose of the region is for a RECIST measurement, then the Concept Name used should be (G-A185, SRT, Long Axis).3>>INFERRED FROMSCOORDEV (121112, DCM, Source of Measurement)1MGRAPHIC TYPE = {POLYLINE} with exactly two points.This use of the concept of source of measurement is consistext with the pattern for DTID 300 and DTID 320 in DICOM PS 3.16.4>>>SELECTED FROMIMAGE1MA reference to a single presentation state shall be present. The presentation state shall not contain annotations.5>CONTAINSNUMEV (G-A185, SRT, Long Axis)1MCRequired if $MeasurementType is (RP-100104, 99RPH, Biorthogonal Line Segments) or (RP-101016, 99RPH, Triorthogonal Line Segments)Units EV (mm, UCUM, mm) or EV ({pixels}, UCUM, pixels)6>>INFERRED FROMSCOORDEV (121112, DCM, Source of Measurement)1MGRAPHIC TYPE = {POLYLINE} with exactly two points.7>>>SELECTED FROMIMAGE1MA reference to a single presentation state shall be present. It shall have the same SOP Instance UID as in Row 10. The presentation state shall not contain annotations.8>CONTAINSNUMEV (G-A186, SRT, Short Axis)1MCRequired if $MeasurementType is (RP-100104, 99RPH, Biorthogonal Line Segments) or (RP-101016, 99RPH, Triorthogonal Line Segments)Units EV (mm, UCUM, mm) or EV ({pixels}, UCUM, pixels)9>>INFERRED FROMSCOORDEV (121112, DCM, Source of Measurement)1MGRAPHIC TYPE = {POLYLINE} with exactly two points.10>>>SELECTED FROMIMAGE1MA reference to a single presentation state shall be present. It shall have the same SOP Instance UID as in Row 7. The presentation state shall not contain annotations.11>CONTAINSNUMEV (RP-101017, 99RPH, Normal Axis)1MCRequired if $MeasurementType is (RP-101016, 99RPH, Triorthogonal Line Segments)Units EV (mm, UCUM, mm) or EV ({pixels}, UCUM, pixels)12>>INFERRED FROMSCOORDEV (121112, DCM, Source of Measurement)1MGRAPHIC TYPE = {POINT} with exactly one point.One of the points defining the line segment perpendicular to the image plane.13>>>SELECTED FROMIMAGE1MA reference to a single presentation state shall be present. It shall have the same SOP Instance UID as in Row 7. The presentation state shall not contain annotations.14>>INFERRED FROMSCOORDEV (121112, DCM, Source of Measurement)1MGRAPHIC TYPE = {POINT} with exactly one point.The other point defining the line segment perpendicular to the image plane.15>>>SELECTED FROMIMAGE1MA reference to a single presentation state shall be present. It shall have the same SOP Instance UID as in Row 7. The presentation state shall not contain annotations.16>CONTAINSNUMEV (RP-100105, 99RPH, Angle)1MCRequired if $MeasurementType is (RP-100105, 99RPH, Angle)Units EV (deg, UCUM, degrees)This is always the acute angle contained by the intersection of the (extended) line segments.17>>INFERRED FROMSCOORDEV (RP-100120, 99RPH, Angle Line Segment)2MGRAPHIC TYPE = {MULTIPOINT} with exactly two points for one line segmentThe two line segments need not intersect, or share a common vertex.18>>>SELECTED FROMIMAGE1MA reference to a single presentation state shall be present. The presentation state shall not contain annotations. Both line segments (Row 17) shall contain an IMAGE reference child, and the references shall be to the same image and presentation state for both.19>HAS OBS CONTEXTCODEEV (RP-101012, 99RPH, Automation)1M$Automation Notes: 1. Rather than indirecting SCOORDS through references to other content items (e.g., IMAGEs in the Image Library), using R-SELECTED FROM the IMAGE content items are replicated in-line using ordinary SELECTED FROM relationships; this is easier to encode and parse and commonality is established because the (Referenced) SOP Instance UIDs are the same. 2. Linear distance will be measured in mm if the image contains Pixel Spacing or Imager Pixel Spacing, as appropriate, or has been calibrated, or in pixels if uncalibrated and no spacing information is available. TID RPH_0007b Sub-Regions and Measurements This template describes regions or measurements defined by 2D (image-relative) spatial coordinates, regions defined by 3D geometric objects, and regions defined by rasterized bitmaps of 3D locations encoded as references to single-segment multi-frame Segmentation Storage SOP Instances, with accompanying measurements. At this time no explicit 3D spatial coordinate mechanism is defined. Regions may be associated with one or more measurements, depending on the type. Regions that are composed of multiple sub-regions, which may be included or excluded in the region, may contain one or more measurements associated with each sub-region, as well as aggregate measurements for the entire region. . TID RPH_0007b Parameters Parameter NameParameter Usage$RegionTypeMay be one of EV (111041, DCM, Outline) or EV (RP-100121, 99RPH, 3D Geometric Object) or EV (G-D705, SRT, Volume). TID RPH_0007b Sub-Regions and Measurements Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1aCONTAINSCONTAINEREV(RP-101003, 99RPH, Image Region)1MAn image region container is needed in order to be able to group multiple sub-regions together and provide simple measurements that apply to the entire region, e.g., automatically derived biorthogonal measurements.1b>CONTAINSCONTAINEREV(RP-100102, 99RPH, Image Sub-region)1-nMMultiple 2D or 3D sub-regions may be necessary to describe a lesion with holes or non-contiguous regions, hence this additional level of nesting. Regions that are closed 2D or 3D structures are always defined to have at least one sub-region, even if there is only one.2>>CONTAINSCODEEV(RP-100034, 99RPH, Include Flag)1MDCID (RPH_7230) Yes-No OnlyWill be present even if only one sub-region is present, in which case will have a value of Yes.3>>CONTAINSCODEEV(122554, DCM, Segmentation Method)1MDCID (RPH_7040) Region Segmentation MethodsE.g., manual (i.e., hand drawn contour or tool) or some (coded) category of semi-automated or automated segmentation3a>>>HAS OBS CONTEXTTEXTEV (RP-100926, 99RPH, Algorithm UID)1MCRequired if Row 3 (122554, DCM, Segmentation Method) is not (G-D221, SRT, Manual).3b>>>HAS OBS CONTEXTCODEEV(RP-100930, 99RPH, Additional Seed Points Used)1UDCID (RPH_7230) Yes-No Only3c>>>HAS OBS CONTEXTCODEEV(RP-100931, 99RPH, Outline Manually Edited)1UDCID (RPH_7230) Yes-No Only3d>>>CONTAINSSCOORDEV (RP-100932, 99RPH, Initial Segmentation Stroke)1UGRAPHIC TYPE = {POLYLINE} with exactly two points.3e>>>>SELECTED FROMIMAGE1M4>>CONTAINSSCOORDEV(111041, DCM, Outline)1-nMCRequired if $RegionType is (111041, DCM, Outline).GRAPHIC TYPE = {ELLIPSE, POLYLINE} For a POLYLINE, the start and end point the same (i.e., it is closed). A rectangle is a special case of a polyline, in that it consists of 4 line segments (5 points) that are constrained to be perpendicular. The ELLIPSE is defined by the endpoints of its minor and major axes (not by a center point and long and short axis vectors). The other graphic types defined in DICOM, POINT, MULTIPOINT and CIRCLE are not used.Multiple outlines may be present, e.g., to describe iso-contours on successive slices constituting a 3D sub-region.4a>>>HAS CONCEPT MODCODEEV(RP-100899, 99RPH,Closed Curve Type)1MCRequired if Row 4 GRAPHIC TYPE is POLYLINE and the points are to be interpreted as control points rather than joined by line segments. Shall not be present if Row 4b is present.DCID (RPH_7070) Closed Curve TypesE.g., if used as the control points of a spline. The absence of this content item means that the points shall be joined as line segments. Additional parameters required to fully specify a spline are not yet defined.4b>>>HAS CONCEPT MODCODEEV(RP-100897, 99RPH,Closed Polygon Type)1MCRequired if Row 4 GRAPHIC TYPE is POLYLINE of a pre-defined shape. Shall not be present if Row 4a is present.DCID (RPH_7071) Closed Polygon TypesE.g., a rectangle. Knowing this allows subsequent editing tools to be more easily aware of the shape being drawn rather than having to use a generic tool, or doing pattern recognition to detect this.5>>>SELECTED FROMIMAGE1MA reference to a presentation state shall be present. The presentation state shall not contain annotations.5a>>CONTAINSCODEEV (RP-100128, 99RPH, 3D Geometric Object Type)1MCRequired if $RegionType is (RP-100121, 99RPH, 3D Geometric Object).DCID RPH_7602 3D Geometric Object Types5b>>CONTAINSSCOORDEV(111041, DCM, Outline)1MCRequired if $RegionType is (RP-100121, 99RPH, 3D Geometric Object).GRAPHIC TYPE = {ELLIPSE, CIRCLE} The ELLIPSE is defined by the endpoints of its minor and major axes (not by a center point and long and short axis vectors). The CIRCLE is defined by the central pixel and a pixel on the perimeter of the circle. The other graphic types defined in DICOM, POINT, MULTIPOINT and POLYLINE are not used.A single outline is used to define the cross section of a 3D Geometric Object.5c>>>SELECTED FROMIMAGE1MA reference to a presentation state shall be present. The presentation state shall not contain annotations.5d>>CONTAINSSCOORDEV(RP-100122, 99RPH, First Extent of 3D Geometric Object)1MCRequired if $RegionType is (RP-100121, 99RPH, 3D Geometric Object).GRAPHIC TYPE = {POINT} The other graphic types defined in DICOM, CIRCLE, ELLIPSE, MULTIPOINT and POLYLINE are not used.One extent of the normal to the cross section defined in Row 5b.5e>>>SELECTED FROMIMAGE1MA reference to a presentation state shall be present. The presentation state shall not contain annotations.5f>>CONTAINSSCOORDEV(RP-100123, 99RPH, Second Extent of 3D Geometric Object)1MCRequired if $RegionType is (RP-100121, 99RPH, 3D Geometric Object).GRAPHIC TYPE = {POINT} The other graphic types defined in DICOM, CIRCLE, ELLIPSE, MULTIPOINT and POLYLINE are not used.The other extent of the normal to the cross section defined in Row 5b.5g>>>SELECTED FROMIMAGE1MA reference to a presentation state shall be present. The presentation state shall not contain annotations.6>>CONTAINSIMAGEEV (RP-100100, 99RPH, Region Raster)1MCRequired if $RegionType is (G-D705, SRT, Volume)SOP Class UID (0008,1150) shall be 1.2.840.10008.5.1.4.1.1.66.4 (Segmentation Storage SOP Class); Referenced Segment Number (0062,000B) shall be 1; there shall be no accompanying reference to a presentation state. An IMAGE rather than COMPOSITE content item is used, since the reference may be to a sub-set of frames.7>>CONTAINSINCLUDETID RPH_0009 Region Measurements1U$RegionType = $RegionTypeThese measurements are of the individual sub-region(s).8>CONTAINSINCLUDETID RPH_0009 Region Measurements1M$RegionType = $RegionTypeThese measurements are of the entire region.9>CONTAINSCODEEV(RP-100503, 99RPH, Measurement Object Type)1UEV (RP-100104, 99RPH, Biorthogonal Line Segments) or EV (RP-101016, 99RPH, Triorthogonal Line Segments)This is to encode an automatically derived coordinates and values applicable to the entire region.10>CONTAINSINCLUDETID RPH_0007a Simple Measurements1MCRequired if Row 9 is present$MeasurementType = Row 9 value $Automation = EV (G-D231, SRT, Automated)Even though the segmentation may have been performed manually, or semi-automatically, the biorthogonal measurement itself is derived fully automatically. Notes: 1. Rather than indirecting SCOORDS through references to other content items (e.g., IMAGEs in the Image Library), using R-SELECTED FROM the IMAGE content items are replicated in-line using ordinary SELECTED FROM relationships; this is easier to encoded and parse and commonality is established because the (Referenced) SOP Instance UIDs are the same. TID RPH_0007c Text Annotations This template describes graphic annotations consisting of text messages that are applied to locations on an image. Text annotations do not have a UID; there is no current intent to load such annotations into OC (i.e., they are not the same as Comments called out elsewhere at the Timepoint and Lesion level). TID RPH_0007c Text Annotations Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1aCONTAINSCONTAINEREV(RP-100106, 99RPH, Text Annotation)1b>CONTAINSSCOORDEV (121055, DCM, Path)1MGRAPHIC TYPE = {MULTIPOINT} with exactly two points.A line is drawn between the two specified points, as a pointer to link the location at which the text is rendered (second point) to the location to which it applies (first point, which is decorated with an arrow head).2>>SELECTED FROMIMAGE1MA reference to a single presentation state shall be present. The presentation state shall not contain annotations.3>CONTAINSTEXTEV(RP-100106, 99RPH, Text Annotation)1MThe value is the text message to be rendered on the image. TID RPH_0007d Measurements Derived From Other Measurements This template describes measurements that are derived from other lesions, regions or measurements. TID RPH_0007d Measurements Derived From Other Measurements Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1aCONTAINSCONTAINEREV (RP-101004, 99RPH, Derived Measurement)1M1b>CONTAINSNUMDCID RPH_7022 Measurements Derived From Other Measurements1M2>>INFERRED FROMUIDREFEV (RP-100112, 99RPH, Source Measurement Object UID)2-nMThe measurement object with the specified UID shall be in the same SR SOP Instance as this derived measurement.The number and order of the UID references are specified in the context group for the parent measurement. An R-INFERRED FROM relationship is not used to point directly to the content item; by-reference relationships are avoided throughout these templates. TID RPH_0009 Region Measurements This template defines geometric (size) and pixel value based measurements made on 2D regions or sub-regions. They may also be used for measurements of planes of a 3D region. TID RPH_0009 Parameters Parameter NameParameter Usage$RegionTypeThe type of region, in order to constrain, types of measurements that are meaningful.  TID RPH_0009 REGION MEASUREMENTS Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINSNUMDCID RPH_7018 (Region Linear Measurements)1-nUUnits EV (mm, UCUM, mm) or EV ({pixels}, UCUM, pixels). See Note 1.E.g., perimeter of sub-region or region.2CONTAINSNUMDCID RPH_7019 (Region Area Measurements)1-nUCMay only be present if $RegionType is (111041, DCM, Outline)Units EV (mm2, UCUM, mm2) or EV ({pixels}, UCUM, pixels) See Note 1.E.g., area of sub-region or region.3>HAS CONCEPT MODCODEEV (G-C036, SRT, Measurement Method)1UDCID (7473) General Area Calculation MethodsE.g., Area of closed irregular polygon.4CONTAINSNUMDCID RPH_7020 (Region Volume Measurements)1-nUCMay only be present if $RegionType is (111041, DCM, Outline) or (G-D705, SRT, Volume)Units EV (mm3, UCUM, mm3) or EV ({pixels}, UCUM, pixels) See Note 1.E.g., volume of sub-region or region.5>HAS CONCEPT MODCODEEV (G-C036, SRT, Measurement Method)1UDCID (7474) General Volume Calculation MethodsE.g., Integration of sum of closed areas on contiguous slices.6CONTAINSNUMEV (RP-100410, 99RPH, Pixel Count)1UUnits EV ({count}, UCUM, count)7CONTAINSNUMDCID RPH_7021 (Region Pixel Value Measurements)1-nUCUnits depend on measurement and are defined in DCID RPH_7021.E.g., HU or SUVbw of sub-region or region.8>HAS CONCEPT MODCODEEV(121401, DCM, Derivation)1MDCID(RPH_7030) Measurement Derivation ModifiersE.g., mean, max, SD9>HAS CONCEPT MODCODEEV (G-C036, SRT, Measurement Method)1UDCID (7473) General Area Calculation Methods or DCID (7474) General Volume Calculation MethodsE.g., Integration of sum of closed areas on contiguous slices. Notes: 1. Linear distance will be measured in mm if the image contains Pixel Spacing or Imager Pixel Spacing, as appropriate, or has been calibrated, or in pixels if uncalibrated and no spacing information is available. Area and volume will also be reported in pixels if uncalibrated and no spacing information is available (and not pixels squared or cubed). TID RPH_0010 Clinical Trial Results Image Library Entry Template Each instance of the Image Library Entry template contains the Image SOP Class and Instance UIDs, and selected attributes for an image. If values for the attributes are not present in the Image SOP Instance, then as many of the attributes as possible should be derived. It is similar to the standard TID 4020 CAD Image Library Entry to include additional information specific to clinical trials across a broad range of different modalities. Unlike TID 4020, it is extensible to allow implementations to add any further necessary information. Unlike TID 4020, no Study level date and time information is included, since this would be redundant with information encoded in the Time Point related templates. TID RPH_0010 CLINICAL TRIAL RESULTS IMAGE LIBRARY ENTRY Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1CONTAINSIMAGE1MA reference to a presentation state shall not be present2>HAS ACQ CONTEXTNUMEV (111026, DCM, Horizontal Pixel Spacing)1MCShall be present if Imager Pixel Spacing (0018,1164) or Pixel Spacing (0028,0030) or Nominal Scanned Pixel Spacing (0018,2010) is in the Image Instance, or if Row 2a is present, and derived accordingly.UNITS = EV (mm, UCUM, millimeter)This and similar content items allow retrospective geometric size computations from spatial coordinates without requiring ccess to the images. Unlike TID 4020, the units are consrained to be mm not m.2a>>HAS PROPERTIESUIDREFEV(RP-100403, 99RPH,  Measurement Object UID )1MCRequired if the image has been manually calibrated.The linear distance measurement object used to calibrate the horizontal spacing. May be the same UID as Row 3a if a single calibration applies to both row and column spacing. If an image is recalibrated, the change reason will be recorded in the audit trail entry of the referenced measurement object.3>HAS ACQ CONTEXTNUMEV (111066, DCM, Vertical Pixel Spacing)1MCShall be present if Imager Pixel Spacing (0018,1164) or Pixel Spacing (0028,0030) or Nominal Scanned Pixel Spacing (0018,2010) is in the Image Instance, or if Row 3a is present, and derived accordingly.UNITS = EV (mm, UCUM, millimeter)3a>>HAS PROPERTIESUIDREFEV(RP-100403, 99RPH, Measurement Object UID)1MCRequired if the image has been manually calibrated.The linear distance measurement object used to calibrate the vertical spacing. May be the same UID as Row 2a if a single calibration applies to both row and column spacing.4>HAS ACQ CONTEXTNUMEV (RID12405, RADLEX, Reconstruction Interval)1MCShall be present if Image Position (Patient) (0020,0032) and Image Orientation (Patient) (0020,0037) are in the Image Instance, or if Row 6 is present, and derived accordingly.UNITS = EV (mm, UCUM, millimeter)For digitally acquired images that are regularly sampled as a 3D dataset, this is the distance along the normal to the slice orientation between the centers of reconstructed slices in the same orientation. This definition circumvents the need to specify a different interval to the slice above and the slice below (if any). For calibrated images, this is a value entered by the user.5>HAS ACQ CONTEXTNUMEV (RID12636, RADLEX, Slice Thickness)1MCShall be present if Slice Thickness (0018,0050) is in the Image Instance, and derived accordingly.UNITS = EV (mm, UCUM, millimeter)Not used in calibrated images.6>HAS ACQ CONTEXTTEXTEV (RP-100881, 99RPH, Message Digest)1MA hash value of the entire image file as supplied to the reading application, encoded as a hexadecimal string.The generic mechanism of PS 3.3 Table C.17-3 SOP Instance Reference Macro and Section C.12.1.1.3 Digital Signatures Macro is not used, since these require digital signature certificates and a PKI be present. The terminology of MAC rather than hash is used for consistency with the digital signatures features in DICOM.7>>HAS PROPERTIESCODEEV (RP-100882, 99RPH, Message Digest Algorithm)1MDCID(RPH_7060) Message Digest Algorithms8>>HAS PROPERTIESCODEEV (RP-100886, 99RPH, Message Digest Scope)1MEV (RP-100887, 99RPH, Entire file)However, the limitation of a simplistic scheme of hashing all bytes in a file (rather than selective components of selective attributes) means that the message digest will be different if the representation of the same meaning changes (e.g., implicit to explicit value representation, addition or removal of group lengths, change in sequence item length encoding (fixed or delimited) or change in meta-information header content (when transmitted using DICOM network protocols). This content item is provided to describe what mechanism was used, though currently there is only one; it allows changing to a more tolerant scheme in the future. This is a deviation from the original SRS-MR-006 and SFS-1500, which specified that the hash be performed only on the pixel data.9>HAS ACQ CONTEXTTEXTEV (RP-101090, 99RPH, Input URL)1UAllows for check against current work list sub-task to see if referenced image is supposed to be available for current sub-task or not. TID RPH_0020 Audit Trail Entry Template This template is included for any observation that requires an entry in the audit trail, including general and time point lesion observations, measurement objects, and time point observations. TID RPH_0020 Parameters Parameter NameParameter Usage$ChangeReasonsThe context group of change reasons.$AdditionReasonsThe context group of addition reasons TID RPH_0020 AUDIT TRAIL ENTRY Type: Extensible NLRel with ParentVTConcept NameVMReq TypeConditionValue Set ConstraintNotes1HAS OBS CONTEXTCODEEV (RP-100090, 99RPH, Completed)1MDCID (RPH_7230) Yes-No OnlyImplies that any subsequent changes will require permission, change reasons and an audit trail entry.2aCONTAINSCONTAINEREV (RP-101010, 99RPH, Creation Information)1M2b>HAS OBS CONTEXTDATETIMEEV(RP-100920, 99RPH, Observation Creation DateTime)1MThis is more specific than replying on the Observation DateTime (0040,A032) Attribute, which may or may not be present in a content item, and has no specific semantics with respect to creation, modification or addition.3>HAS OBS CONTEXTTEXTEV (RP-100006, 99RPH, Person Observers Login Name)1MThe observer who created the observation. Is always explicit, and never assumed to be the creator of the current sub-task, since may have been created by a different observer in a previous sub-task.4>HAS OBS CONTEXTUIDREFEV (RP-100082, 99RPH, Worklist Sub-task UID)1MProvides a reference to the sub-task (and parent task) information for the sub-task in which the observation was created.5aCONTAINSCONTAINEREV (RP-101011, 99RPH, Modification Information)1-nMCRequired if the observation whose Row 1 EV (RP-100090, 99RPH, Completed) is (R-0038D,SRT, Yes) has been edited (changed) (i.e., since the observation was created and an electronic signature applied).The condition on the completion flag is relative to when the information was loaded for the sub-task (i.e., the flag was set in a previous sub-task). This modification entry applies to all properties of the observation (e.g., for a time point lesion observation, everything that is said at this time point about the entire lesion; even if two properties have changed (e.g., there is a property added and a comment made), there is only a single change reason (and change reason comment). May be multiple, since multiple successive changes may have been performed on successive sub-tasks, or both a recalibration and another type of modification may have been made in the same sub-task.5b>HAS OBS CONTEXTDATETIMEEV(RP-100921, 99RPH, Observation Modification DateTime)1M6>HAS OBS CONTEXTTEXTEV (RP-100006, 99RPH, Person Observers Login Name)1MThe observer who modified the observation. Is always explicit, and never assumed to be the creator of the current sub-task, since may have been modified by a different observer in a previous sub-task (i.e., for a substitute read or correction).7>HAS OBS CONTEXTUIDREFEV (RP-100082, 99RPH, Worklist Sub-task UID)1MProvides a reference to the sub-task (and parent task) information for the sub-task in which the observation was modified.8>HAS OBS CONTEXTCODEEV(RP-100058, 99RPH, Edit Reason)1MDCID $ChangeReasons9>>HAS OBS CONTEXTTEXTEV(RP-100923, 99RPH, Edit Comment)1UThere does not need to be a comment, and there can only be one comment.10HAS OBS CONTEXTCODEEV(RP-100922, 99RPH, Additional Observation)1MCRequired if the observation is additional to a parent entity that has previously been completed (i.e., a parent, such as a time point, with a content item EV (RP-100090, 99RPH, Completed) with a value of (R-0038D,SRT, Yes)).EV (R-0038D,SRT, Yes)This flag indicates that an observation was added retrospectively, and is present to capture the identity of the observer making the addition and the reason for the addition, as distinct from a modification to an existing observation. Only one addition entry may be present per observation, since subsequent changes would be modifications. Absence of this content item means that an observation is not additional (i.e., it is an initial observation). Used, for example, to indicate that an additional target lesion was added to a baseline time point retrosopectively (i.e., after it had been completed, and whilst reading a future time point).10b>HAS OBS CONTEXTDATETIMEEV(RP-101014, 99RPH, Observation Addition DateTime)1M11>HAS OBS CONTEXTTEXTEV (RP-100006, 99RPH, Person Observers Login Name)1MThe observer who modified the observation. Is always explicit, and never assumed to be the creator of the current sub-task, since may have been modified by a different observer in a previous sub-task (i.e., for a substitute read or correction).12>HAS OBS CONTEXTUIDREFEV (RP-100082, 99RPH, Worklist Sub-task UID)1MProvides a reference to the sub-task (and parent task) information for the sub-task in which the observation was added.13>HAS OBS CONTEXTCODEEV(RP-100058, 99RPH, Edit Reason)1MDCID $AdditionReasons14>>HAS OBS CONTEXTTEXTEV(RP-100923, 99RPH, Edit Comment)1U Context Groups CID RPH_7001 Clinical Trial Performing Roles Context ID RPH_7001 Clinical Trial Performing Roles Type: Extensible Version: 20101116 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100002Reader99RPHRP-101040Radiology Reader99RPHRP-101041Post-Radiology PET Reader99RPHRP-101042Oncology Reader99RPHRP-101043Post-Radiology Oncology Reader99RPHRP-101044Non-Oncology Photography Reader99RPHRP-100003Eligibility Reader99RPHRP-101049Eligibility Radiology Reader99RPHRP-101050Eligibility Oncology Reader99RPHRP-101055PET Reader99RPHRP-100004Adjudicator99RPHRP-101045Radiology Adjudicator99RPHRP-101046Oncology Adjudicator99RPHRP-101051Eligibility Radiology Adjudicator99RPHRP-101052Eligibility Oncology Adjudicator99RPHRP-101056PET Adjudicator99RPHRP-100005Reviewer99RPHRP-101031Designator99RPHRP-101032Adjudicator Repeating Read99RPHRP-101047Adjudicator Repeating Radiology Read99RPHRP-101048Adjudicator Repeating Oncology Read99RPHRP-101053Adjudicator Repeating Eligibility Radiology Read99RPHRP-101054Adjudicator Repeating Eligibility Oncology Read99RPHRP-101057Adjudicator Repeating PET Read99RPHRP-101033Quality Control Images99RPHRP-101034Quality Control Results99RPHRP-101037Quality Control Radiotherapy Plan99RPHRP-101035Eligibility Adjudicator99RPHRP-101036Adjudicator Repeating Eligibility Read CID RPH_7001b Clinical Trial Adjudicated Roles Context ID RPH_7001b Clinical Trial Adjudicated Roles Type: Extensible Version: 20090923 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100002Reader99RPHRP-101040Radiology Reader99RPHRP-101042Oncology Reader99RPHRP-100003Eligibility Reader99RPHRP-101049Eligibility Radiology Reader99RPHRP-101050Eligibility Oncology Reader CID RPH_7002 Clinical Trial Worklist Task Type Context ID RPH_7002 Clinical Trial Worklist Task Type Type: Extensible Version: 20110516 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Notes99RPHRP-100800Radiology99RPHRP-100801Oncology99RPHRP-100802PET99RPHRP-100803Eligibility Radiology99RPHRP-100804Eligibility Oncology99RPHRP-100805Eligibility Non-Oncology99RPHRP-100806Non-Oncology Photo99RPHRP-100807Radiology/PET99RPHRP-100808Overall99RPHRP-100809Review99RPHRP-100810RTQA99RPHRP-100811Individual Randomized99RPHRP-100812Comparison Randomized CID RPH_7003 Clinical Trial Worklist Task Category Context ID RPH_7003 Clinical Trial Worklist Task Category Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Notes99RPHRP-100220Sequential Locked Read99RPHRP-100221Sequential Unlocked Read99RPHRP-100222Non-sequential Unlocked Read CID RPH_7003b Clinical Trial Worklist Task Levels Context ID RPH_7003b Clinical Trial Worklist Task Levels Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Notes99RPHRP-100213Perform initial taskI.e., initial read99RPHRP-100214Perform comparisonI.e., level 1 adjudication99RPHRP-100215Repeat rejected taskI.e., level 2 adjudication CID RPH_7003c Clinical Trial Worklist Task Repeat Types Context ID RPH_7003c Clinical Trial Worklist Task Repeat Types Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Notes99RPHRP-100230Supplemental Read99RPHRP-100231Repeat Read CID RPH_7003d Clinical Trial Worklist Task Variability Types Context ID RPH_7003d Clinical Trial Worklist Task Variability Types Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Notes99RPHRP-100234Intraobserver variability99RPHRP-100235Interobserver variability CID RPH_7004 Lesion Type Context ID RPH_7004 Lesion Type Type: Extensible Version: 20090923 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100029Target lesion99RPHRP-100030Non-target lesion99RPHRP-100031New lesion99RPHRP-100035Background lesion99RPHRP-100320Calibration CID RPH_7006 Anatomic Sites for Lesions Context ID RPH_7006 Anatomic Sites for Lesions Type: Extensible Version: 20090623 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Include CID RPH_7006a Anatomic Sites for Lesions CNSInclude CID RPH_7006b Anatomic Sites for Lesions NodesInclude CID RPH_7006c Anatomic Sites for Lesions Viscera and Soft TissueInclude CID RPH_7006d Anatomic Sites for Lesions SkeletalInclude CID RPH_7006e Anatomic Sites for Lesions SkinInclude CID RPH_7006f Anatomic Sites for Lesions Fluid Collections CID RPH_7006a Anatomic Sites for CNS Lesions Context ID RPH_7006a Anatomic Sites for CNS Lesions Type: Extensible Version: 20090623 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Laterality Unilateral (See Note 2)SNOMED (SRT) Equivalent99RPANATLOC27BrainNo99RPANATLOC84Frontal LobeNo99RPANATLOC86Occipital LobeNo99RPANATLOC92FrontoparietalNo99RPANATLOC93FrontotemporalNo99RPANATLOC94ParietoccipitalNo99RPANATLOC95TemporaloccipitalNo99RPANATLOC96TemporalparietalNo99RPANATLOC85Parietal LobeNo99RPANATLOC87Temporal LobeNo99RPANATLOC98Fourth VentricleYes99RPANATLOC97Lateral VentricleNo99RPANATLOC99Third VentricleYes99RPANATLOC88Basal GangliaNo99RPANATLOC89ThalamusNo99RPANATLOC90BrainstemNo99RPANATLOC91CerebellumNo99RPANATLOC156CaudateNo99RPANATLOC157DuralYes99RPANATLOC162EpiduralYes99RPANATLOC163SubduralYes99RPANATLOC164Spinal CordYes99RPANATLOC158FalxYes99RPANATLOC159Corpus CallosumYes99RPANATLOC160Hippocampus No99RPANATLOC161Leptomeningeal No Notes: 1. We could actually use SNOMED codes rather than CoreLab Partners codes in the DICOM SR encoding, and map back and forth from the user interface, but this is probably unnecessary work; better to just note the correspondence with standard codes like SNOMED here, and use the CoreLab Partners numeric codes for now. 2. I.e., either (G-C171, SRT, Laterality) always set to (G-A103, SRT, Unilateral), or may be one of (G-A100, SRT, Right), (G-A101, SRT, Left) or (G-A102, SRT, Right and left). CID RPH_7006b Anatomic Sites for Lesions Nodes Context ID RPH_7006b Anatomic Sites for Lesions Nodes Type: Extensible Version: 20090714 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Laterality UnilateralSNOMED (SRT) Equivalent99RPANATLOC165NodesYes99RPANATLOC1Waldeyers RingNo99RPANATLOC2Pre-Auricular NodesNo99RPANATLOC25Submental NodesNo99RPANATLOC166Cervical NodesNo99RPANATLOC3Upper Cervical NodesNo99RPANATLOC4Middle or Lower Cervical NodesNo99RPANATLOC5Post-Cervical Nodes No99RPANATLOC6Supraclavicular Nodes No99RPANATLOC7Infraclavicular Nodes No99RPANATLOC26Subpectoral Nodes No99RPANATLOC81Thoracic Nodes No99RPANATLOC8Paratracheal Nodes No99RPANATLOC9Mediastinal Nodes No99RPANATLOC10Hilar Nodes No99RPANATLOC68Sub-Carinal NodesYes99RPANATLOC11Axillary Nodes No99RPANATLOC12Epitrochlear Nodes No99RPANATLOC13Retrocrural Nodes No99RPANATLOC82Abdominal Nodes No99RPANATLOC15Splenic Hilar NodesYes99RPANATLOC16Portal NodesYes99RPANATLOC17Celiac NodesYes99RPANATLOC32Paracardiac Nodes No99RPANATLOC37Aorto Caval Nodes No99RPANATLOC18Para-Aortic Nodes No99RPANATLOC51Epicardial Nodes No99RPANATLOC69Cardiophrenic Nodes No99RPANATLOC19Mesenteric Nodes No99RPANATLOC70Peripancreatic NodesNo99RPANATLOC71Retroperitoneal Nodes No99RPANATLOC83Pelvic Nodes No99RPANATLOC20Common Iliac Nodes No99RPANATLOC72Internal Iliac Nodes No99RPANATLOC21External Iliac Nodes No99RPANATLOC22Inguinal Nodes No99RPANATLOC73Pre-Sacral NodesYes99RPANATLOC74Perirectal Nodes No99RPANATLOC23Femoral Nodes No99RPANATLOC24Popliteal Nodes No Notes: 1. These anatomic sites may be used to refer to single lymph nodes (e.g., when measuring a lymph node as a target lesion as per RECIST 1.1), or a group of lymph nodes in the same location that have coalesced into a single mass (and may or may not be measured according to response criteria). Whether or not the reference is to a single node or multiple nodes may be encoded separately. CID RPH_7006c Anatomic Sites for Lesions Viscera and Soft Tissue Context ID RPH_7006c Anatomic Sites for Lesions Viscera and Soft Tissue Type: Extensible Version: 20090714 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Laterality UnilateralSNOMED (SRT) Equivalent99RPANATLOC167Extranodal VisceraYes99RPANATLOC52MuscleYes99RPANATLOC100Eye/Orbit No99RPANATLOC168NoseYes99RPANATLOC75Oral Cavity No99RPANATLOC76TongueYes99RPANATLOC77Parotid No99RPANATLOC78SubmandibularNo99RPANATLOC169PharynxNo99RPANATLOC101NasopharynxNo99RPANATLOC56OropharynxNo99RPANATLOC170HypopharynxNo99RPANATLOC102Paranasal Sinuses No99RPANATLOC172Maxillary SinusNo99RPANATLOC173Frontal SinusNo99RPANATLOC174Sphenoid SinusNo99RPANATLOC175Ethmoid SinusNo99RPANATLOC45Neck (Soft Tissue)No99RPANATLOC57Larynx No99RPANATLOC28Thyroid No99RPANATLOC79Thoracic No99RPANATLOC128Shoulder Soft TissueNo99RPANATLOC131Upper Arm Soft TissueNo99RPANATLOC176Forearm Soft TissueNo99RPANATLOC177Wrist Soft TissueNo99RPANATLOC178Hand Soft TissueNo99RPANATLOC179MediastinumNo99RPANATLOC67BreastNo99RPANATLOC59AxillaNo99RPANATLOC30Pleural CavityNo99RPANATLOC29LungNo99RPANATLOC14Trachea/BronchiYes99RPANATLOC55EsophagusYes99RPANATLOC103AortaYes99RPANATLOC104HeartYes99RPANATLOC80ParacardiacNo99RPANATLOC114CardiophrenicNo99RPANATLOC105PericardiumYes99RPANATLOC115EpicardiumNo99RPANATLOC106Superior Vena CavaYes99RPANATLOC107Diaphragm No99RPANATLOC116Thoracic Inlet No99RPANATLOC180ParaspinalNo99RPANATLOC117AbdomenNo99RPANATLOC63Peritoneum/omentumYes99RPANATLOC33LiverYes99RPANATLOC53Biliary Tract/GallbladderYes99RPANATLOC31SpleenYes99RPANATLOC118MesentericNo99RPANATLOC119PeripancreaticYes99RPANATLOC54PancreasYes99RPANATLOC34StomachYes99RPANATLOC109RetroperitoneumNo99RPANATLOC65AdrenalNo99RPANATLOC35KidneyNo99RPANATLOC120Renal FossaNo99RPANATLOC121Pre-SacralYes99RPANATLOC50Small BowelYes99RPANATLOC38ColonYes99RPANATLOC122Peri-CecalYes99RPANATLOC123PerirectalNo99RPANATLOC108RectumYes99RPANATLOC110UreterNo99RPANATLOC111BladderYes99RPANATLOC112Pelvic Soft TissueNo99RPANATLOC61UterusYes99RPANATLOC60VaginaYes99RPANATLOC113ProstateYes99RPANATLOC39GonadNo99RPANATLOC124TesticleNo99RPANATLOC125OvaryNo99RPANATLOC145Upper Leg No99RPANATLOC181KneeNo99RPANATLOC182Lower Leg Soft TissueNo99RPANATLOC183Foot Soft TissueNo CID RPH_7006d Anatomic Sites for Lesions Skeletal Context ID RPH_7006d Anatomic Sites for Lesions Skeletal Type: Extensible Version: 20090714 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Laterality UnilateralSNOMED (SRT) Equivalent99RPANATLOC126Skull No99RPANATLOC44Skull Base Yes99RPANATLOC184Facial BonesYes99RPANATLOC127Mandible No99RPANATLOC197AcromioclavicularNo99RPANATLOC129Clavicle No99RPANATLOC130Scapula No99RPANATLOC198SternoclavicularNo99RPANATLOC132Humerus No99RPANATLOC199ElbowNo99RPANATLOC133Ulna No99RPANATLOC134Radius and Ulna No99RPANATLOC135Radius No99RPANATLOC136Carpus No99RPANATLOC137MetacarpusNo99RPANATLOC185Phalanges (fingers)No99RPANATLOC46Cervical SpineYes99RPANATLOC138Cervical Spine (multiple)Yes99RPANATLOCC1C1Yes99RPANATLOCC2C2Yes99RPANATLOCC3C3Yes99RPANATLOCC4C4Yes99RPANATLOCC5C5Yes99RPANATLOCC6C6Yes99RPANATLOCC7C7Yes99RPANATLOC139SternumYes99RPANATLOC140Ribs (multiple)No99RPANATLOCX1Rib 1No99RPANATLOCX2Rib 2No99RPANATLOCX3Rib 3No99RPANATLOCX4Rib 4No99RPANATLOCX5Rib 5No99RPANATLOCX6Rib 6No99RPANATLOCX7Rib 7No99RPANATLOCX8Rib 8No99RPANATLOCX9Rib 9No99RPANATLOCX10Rib 10No99RPANATLOCX11Rib 11No99RPANATLOCX12Rib 12No99RPANATLOC47Thoracic Spine Yes99RPANATLOC141Thoracic Spine (multiple)Yes99RPANATLOCT1T1Yes99RPANATLOCT2T2Yes99RPANATLOCT3T3Yes99RPANATLOCT4T4Yes99RPANATLOCT5T5Yes99RPANATLOCT6T6Yes99RPANATLOCT7T7Yes99RPANATLOCT8T8Yes99RPANATLOCT9T9Yes99RPANATLOCT10T10Yes99RPANATLOCT11T11Yes99RPANATLOCT12T12Yes99RPANATLOC48Lumbar Spine Yes99RPANATLOC142Lumbar Spine (multiple)Yes99RPANATLOCLS1L1Yes99RPANATLOCLS2L2Yes99RPANATLOCLS3L3Yes99RPANATLOCLS4L4Yes99RPANATLOCLS5L5Yes99RPANATLOC49SacrumYes99RPANATLOC143Sacrum (multiple)Yes99RPANATLOCS1S1Yes99RPANATLOCS2S2Yes99RPANATLOCS3S3Yes99RPANATLOCS4S4Yes99RPANATLOCS5S5Yes99RPANATLOC144Hip No99RPANATLOC200SacroiliacNo99RPANATLOC186IliumNo99RPANATLOC187AcetabulumNo99RPANATLOC188IschiumNo99RPANATLOC189PubisNo99RPANATLOC190CoccyxYes99RPANATLOC146Femur No99RPANATLOC191Femur NeckNo99RPANATLOC192Femur SubtrochanterNo99RPANATLOC193Femur MidshaftNo99RPANATLOC194Femur DistalNo99RPANATLOC147Patella No99RPANATLOC148Fibula No99RPANATLOC149Tibia No99RPANATLOC150Tibia and FibulaNo99RPANATLOC151TarsusNo99RPANATLOC152MetatarsusNo99RPANATLOC195CalcaneusNo99RPANATLOC196Phalanges (Toes)No99RPANATLOC36BoneYes99RPANATLOC153Bone MarrowYes Notes: 1. These anatomic sites may be used to indicate that a lesion is a bone lesion, and hence different rules applied when deriving response criteria (e.g., one may not measure the size of a bone lesion). CID RPH_7006e Anatomic Sites for Lesions Skin Context ID RPH_7006e Anatomic Sites for Lesions Skin Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Laterality UnilateralSNOMED (SRT) Equivalent99RPANATLOC41Subcutaneous Yes99RPANATLOC66SkinYes99RPANATLOC58Chest Wall No99RPANATLOC154Abdominal Wall No99RPANATLOC155BackYes CID RPH_7006f Anatomic Sites for Lesions Fluid Collections Context ID RPH_7006f Anatomic Sites for Lesions Fluid Collections Type: Extensible Version: 20090623 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Laterality UnilateralSNOMED (SRT) Equivalent99RPANATLOC62Pleural Effusion No99RPANATLOC64Pericardial EffusionYes99RPANATLOC43AscitesYes CID RPH_7007 Anatomic Regions for Radiology Procedures Context ID RPH_7007 Anatomic Regions for Radiology Procedures Type: Extensible Version: 20091117 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Laterality UnilateralBody Part Examined (0018,0015)SRTT-D4000AbdomenYesABDOMENSRTT-B3000Adrenal glandYesADRENALSRTR-FAB57Abdomen and PelvisYesABDOMENPELVISSRTT-15750AnkleNoANKLESRTT-D8100AxillaNoAXILLASRTT-A9092Brachial PlexusNoSRTT-A0100BrainYesBRAINSRTT-04000BreastNoBREASTSRTT-12770CalcaneusNoCALCANEUSSRTT-45010Carotid ArteryNoCAROTIDSRTT-A010DCerebral vesselsYesSRTT-11501Cervical spineYesCSPINESRTT-D00F7Cervico-thoracic spineYesCTSPINESRTT-D3000ChestYesCHESTSRTR-FAB55Chest and AbdomenYesCHESTABDOMENSRTR-FAB56Chest, Abdomen and PelvisYesCHESTABDPELVISSRTT-12310ClavicleNoCLAVICLESRTT-11BF0CoccyxYesCOCCYXSRTT-43000Coronary artery YesCORONARYARTERYSRTT-D8300ElbowNoELBOWSRTT-11002Entire bony skeletonYesSRTT-11196Facial bonesYesSRTT-12710FemurNoFEMURSRTT-D9700FootNoFOOTSRTT-12402ForearmNoSRTT-D0010Whole bodyYesWHOLEBODYSRTT-D8700HandNoHANDSRTT-D064DHand and wristNoSRTT-D1100HeadYesHEADSRTT-D1000Head and NeckYesHEADNECKSRTT-32000HeartYesHEARTSRTT-15710HipNoHIPSRTT-12410HumerusNoHUMERUSSRTT-48710Inferior vena cavaYesSRTT-71000KidneyNoKIDNEYSRTT-D9200KneeNoKNEESRTT-62000LiverYesLIVERSRTT-D0680Lower extremityNoSRTT-D9400Lower LegNoLEGSRTT-11503Lumbar spineYesLSPINESRTT-D00F9Lumbo-sacral spineYesLSSPINESRTT-11180MandibleYesJAWSRTT-D1600NeckYesNECKSRTT-D14AEOrbitNoORBITSRTT-22000Paranasal sinusYesSRTT-D6000PelvisYesPELVISSRTT-9200BProstateYesPROSTATESRTT-44000Pulmonary arteryYesSRTT-11300RibNoRIBSRTT-15680Sacroiliac jointNoSRTT-11AD0SacrumYesSSPINESRTT-12280ScapulaNoSCAPULASRTT-D2220ShoulderNoSHOULDERSRTT-11100SkullYesSKULLSRTT-D0146SpineYesSPINESRTT-15610Sternoclavicular jointNoSRTT-11210SternumYesSTERNUMSRTT-48610Superior vena cavaYesSRTT-D9100ThighNoTHIGHSRTT-11502Thoracic spineYesTHIGHSRTT-D00F8Thoraco-lumbar spineYesTLSPINESRTT-B6000ThyroidYesTHYROIDSRTT-D8200Upper armNoARMSRTT-D0677Upper extremityNoSRTT-15460WristNoWRIST Notes: 1. This table is derived from the larger set defined in DICOM PS 3.16 Annex L. 2. The Body Part Examined value is provided for reference to the value that may be present in the image objects (and hence perhaps automatically derived). CID RPH_7007b Anatomic Regions for External Photography Procedures Context ID RPH_7007b Anatomic Regions for External Photography Procedures Type: Extensible Version: 20090723 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Laterality UnilateralBody Part Examined (0018,0015)SRTT-028801st ToeNoSRTT-D88082nd (Index) FingerNoSRTT-028902nd ToeNoSRTT-D88093rd (Middle) FingerNoSRTT-029003rd ToeNoSRTT-D880A4th (Ring) FingerNoSRTT-029104th ToeNoSRTT-D880B5th (Little) FingerNoSRTT-029205th ToeNoSRTT-D0691AbdomenYesSRTT-D9503AnkleNoSRTT-D300EAnterior Chest WallNoSRTT-D1618Anterior NeckYesSRTT-D9107Anterior ThighNoSRTT-D06A4ArmNoSRTT-D8106AxillaNoSRTT-D0690BackYesSRTT-0243ABreastNoSRTT-D00C9ButtockNoSRTT-0212FCheekNoSRTT-D3005Chest WallNoSRTT-0216DChinYesSRTT-D1617Clavicular RegionNoSRTT-D9731Dorsal FootNoSRTT-D8731Dorsal HandNoSRTT-0220BEarNoSRTT-D079DElbowNoSRTT-D0303ExtremityNoSRTT-02138EyelidNoSRTT-02124FaceYesSRTT-D8807FingerNoSRTT-D2312FlankNoSRTT-D06ADFootNoSRTT-D1111ForeheadYesSRTT-02505Genital RegionYesSRTT-D7002GroinNoSRTT-D06A9HandNoSRTT-D067EHeadYesSRTT-02844HeelNoSRTT-D2507HipNoSRTT-D06E8JawYesSRTT-D9207KneeNoSRTT-D300FLateral Chest WallNoSRTT-D07AFLateral NeckNoSRTT-52800LipsYesSRTT-D4008Lower AbdomenNoSRTT-D06A7Lower ArmNoSRTT-D2122Lower BackNoSRTT-D300ALower Chest WallYesSRTT-D06AALower ExtremityNoSRTT-D06ACLower LegNoSRTT-52201Lower LipYesSRTT-51000MouthYesSRTT-D067FNeckNoSRTT-04104NippleNoSRTT-D07ABNoseYesSRTT-D0778Occipital RegionNoSRTT-D14AFOrbitNoSRTT-D8741Palmar HandNoSRTT-D9745Plantar FootNoSRTT-D9311Popliteal FossaNoSRTT-D300BPosterior Chest WallNoSRTT-D1627Posterior NeckYesSRTT-02812Posterior ThighNoSRTT-D1163ScalpYesSRTT-D2223ShoulderNoSRTT-D0776TempleNoSRTT-D06ABThighNoSRTT-D8817ThumbNoSRTT-D0692ToeNoSRTT-5300CTongueYesSRTT-D4007Upper AbdomenNoSRTT-D06A5Upper ArmNoSRTT-D3012Upper BackYesSRTT-D3013Upper Chest WallYesSRTT-52104Upper LipYesSRTT-D07ADUpper NeckNoSRTT-D8604WristNo Note: In choosing SNOMED concepts for external photography, used surface region concepts, when available, else entire skin of concepts. CID RPH_7010 Non-Target Lesion Response Context ID RPH_7010 Non-Target Lesion Response Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)RADLEXRID11515PD Progressive DiseaseRADLEXRID11514SD Stable DiseaseRADLEXRID11513PR Partial ResponseRADLEXRID11511CR Complete Response99RPHRP-100041LR Lesion Removed CID RPH_7010b PET Target Lesion Qualitative Response Context ID RPH_7010b PET Target Lesion Qualitative Response Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100270PMD Progressive metabolic disease99RPHRP-100271SMD Stable metabolic disease99RPHRP-100272PMR Partial metabolic response99RPHRP-100273CMR Complete metabolic response CID RPH_7010c PET Lesion Qualitative Assessment Context ID RPH_7010c PET Lesion Qualitative Assessment Type: Extensible Version: 20090213 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100902Positive PET Finding99RPHRP-100903Negative PET Finding CID RPH_7011 Reasons Unable to Evaluate Lesion Context ID RPH_7011 Reasons Unable to Evaluate Lesion Type: Extensible Version: 20090617 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)DCM111235Quality renders image unusable99RPHRP-100045Lesion obscured99RPHRP-100046Improper field of view99RPHRP-100047Missing window99RPHRP-100048Missing or inconsistent contrast agent or phaseRADLEXRID11262Missing imageRADLEXRID11261Missing exam99RPHRP-100051Change in reconstruction interval99RPHRP-100052Modality changed99RPHRP-100050Change in reconstruction method or parameters99RPHRP-100049Not distinguishable from other lesions99RPHRP-100130Lesion segmentation cannot be performed99RPHRP-100131Attenuation Correction map not available99RPHRP-100132Attenuation Correction map technically limited99RPHRP-100133Poor count statistics99RPHRP-100134Not distinguishable from normal physiologic activity99RPHRP-100135Parameter(s) required for SUV calculation not provided CID RPH_7012 Reasons Unable to Measure Target Lesion Context ID RPH_7012 Reasons Unable to Measure Target Lesion Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100055Too small to measure99RPHRP-100056Lesion resolved99RPHRP-100057Lesion removed CID RPH_7012b Reasons Unable to Measure New Lesion Context ID RPH_7012b Reasons Unable to Measure New Lesion Type: Extensible Version: 20090617 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100055Too small to measure99RPHRP-100056Lesion resolved99RPHRP-100057Lesion removed99RPHRP-100075Lesion unmeasurable CID RPH_7013 Lesion Change Reasons Context ID RPH_7013 Lesion Change Reasons Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0RP-100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100350Correction to lesion label99RPHRP-100059DCF correction99RPHRP-100060Correction based on CMO review99RPHRP-100064Image quality issue lesion not clearly seen99RPHRP-100065Inter-current disease lesion not clearly seen99RPHRP-100062Lesion identified was artifact99RPHRP-100063Lesion identified was benign99RPHRP-100066Lesion incorrectly measured99RPHRP-100069Lesion was in previously irradiated field99RPHRP-100067New bone lesion result of flare phenomenon99RPHRP-100351Recalibration99RPHRP-100061Lesion did not meet qualification requirements CID RPH_7013b Lesion Addition Reasons Context ID RPH_7013b Lesion Addition Reasons Type: Extensible Version: 20090217 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0RP-100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100068Lesion was present previously but not Identified99RPHRP-100072Measuring a non-target lesion to justify progression99RPHRP-100071New clinical data presented99RPHRP-100070New images presented CID RPH_7013c Calibration Change Reasons Context ID RPH_7013c Calibration Change Reasons Type: Extensible Version: 20090218 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0RP-100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100351Recalibration CID RPH_7014 Time Point Change Reasons Context ID RPH_7014 Time Point Change Reasons Type: Extensible Version: 20110825 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100059DCF correction99RPHRP-100060Correction based on CMO review99RPHRP-100076Source measurement changed CID RPH_7014b Adjudication Change Reasons Context ID RPH_7014b Adjudication Change Reasons Type: Extensible Version: 20090217 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100059DCF correction99RPHRP-100060Correction based on CMO review99RPHRP-100071New clinical data presented99RPHRP-100070New images presented CID RPH_7014c Time Point Observation Addition Reasons Context ID RPH_7014c Time Point Observation Addition Reasons Type: Extensible Version: 20090902 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100071New clinical data presented99RPHRP-100070New images presented CID RPH_7015 Signature Meanings Context ID RPH_7015 Signature Meanings Type: Extensible Version: 20110808 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100330Radiology Read Performed99RPHRP-100331Adjudication level 1 Performed99RPHRP-100332Adjudication level 2 Performed99RPHRP-100333Corrections Performed99RPHRP-100334Eligibility Read Performed99RPHRP-100335Oncology Read Performed 99RPHRP-100336PET Read Performed99RPHRP-100340Nuclear Medicine Review Performed99RPHRP-100341CT + PET Read Performed99RPHRP-100342CMO Review Performed99RPHRP-100343Read Result Quality Control Performed99RPHRP-100344Image Quality Control Performed CID RPH_7016 Algorithm Type Context ID RPH_7016 Algorithm Type Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-100087Segmentation algorithm99RPHRP-100088Registration algorithm99RPHRP-100089Propagation algorithm CID RPH_7017 Single Line Segment Measurements Context ID RPH_7017 Single Line Segment Measurements Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTG-A22ALengthDCM121206DistanceSRTG-A220WidthSRTG-D785DepthSRTM-02550DiameterSRTG-A185Long AxisSRTG-A186Short AxisSRTG-A193Major AxisSRTG-A194Minor AxisSRTG-A195Perpendicular AxisSRTG-A196RadiusDCM121207Height CID RPH_7018 Region Linear Measurements Context ID RPH_7018 Region Linear Measurements Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTG-A185Long AxisSRTG-A186Short AxisSRTG-A195Perpendicular AxisSRTG-A197Perimeter Notes: 1. This template is a subset derived from the more generic DICOM PS 3.16 CID 7470 Linear Measurements. CID RPH_7019 Region Area Measurements Context ID RPH_7019 Region Area Measurements Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTG-A166Area Notes: 1. This template is a subset derived from the more generic DICOM PS 3.16 CID 7471 Area Measurements. CID RPH_7020 Region Volume Measurements Context ID RPH_7020 Region Volume Measurements Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTG-D705Volume Notes: 1. This template is a subset derived from the more generic DICOM PS 3.16 CID 7472 Volume Measurements. CID RPH_7021 Region Pixel Value Measurements Context ID RPH_7021 Region Pixel Value Measurements Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)Units Coding Scheme Designator (0008,0102)Units Code Value (0008,0100)xe (0008,0100)Units Code Meaning (0008,0104)xe (0008,0104)DCM112031Attenuation CoefficientUCUM[hnsfU]Hounsfield unit99RPHRP-100107Standardized Uptake Value body weight UCUM{SUVbw}g/mlStandardized Uptake Value body weight 99RPHRP-100108Standardized Uptake Value lean body massUCUM{SUVlbm}g/mlStandardized Uptake Value lean body mass99RPHRP-100109Standardized Uptake Value body surface areaUCUM{SUVbsa}cm2/mlStandardized Uptake Value body surface area Notes: 1. Separate codes are needed for the concept of the value, and the concept of the units. 2. The concepts of mean, maximum, etc. are not pre-coordinate with these codes; the context in which they are used allows or requires them to be post-coordinated with modifiers; see CID RPH_7030 Measurement Derivation Modifiers. CID RPH_7022 Measurements Derived From Other Measurements Context ID RPH_7022 Measurements Derived From Other Measurements Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)Units Coding Scheme Designator (0008,0102)Units Code Value (0008,0100)xe (0008,0100)Units Code Meaning (0008,0104)xe (0008,0104)Source Measurement Constraints99RPHRP-100110Tumor to background ratioUCUM1No unitsUID #1 = tumor UID #2 = background CID RPH_7031 Time Point Numeric Observations Context ID RPH_7031 Time Point Numeric Observations Type: Extensible Version: 20111021 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)Units Coding Scheme Designator (0008,0102)Units Code Value (0008,0100)xe (0008,0100)Units Code Meaning (0008,0104)xe (0008,0104)99RPHRP-100142Sum of the Longest Diameters (SLD)UCUMmmmm99RPHRP-100143Sum of the Product of the Short and Long Diameters (SPD)UCUMmm2mm299RPHRP-100144Change in Sum of the Longest Diameters (SLD) from NadirUCUM%%99RPHRP-100145Change in Sum of the Product of the Short and Long Diameters (SPD) from NadirUCUM%%99RPHRP-100146Change in Sum of the Longest Diameters (SLD) from BaselineUCUM%%99RPHRP-100147Change in Sum of the Product of the Short and Long Diameters (SPD) from BaselineUCUM%% CID RPH_7032 Time Point Numeric Observation Units Context ID RPH_7032 Time Point Numeric Observation Units Type: Extensible Version: 20110808 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)UCUMmmmmUCUMmm2mm2 CID RPH_7030 Measurement Derivation Modifiers Context ID RPH_7030 Measurement Derivation Modifiers Type: Extensible Version: 20091023 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)Include CID 3488 Min/Max/MeanSRTR-10047Standard DeviationSRTR-40507TotalSRTR-00319MedianSRTR-0032EMode99RPHRP-101080Local Mean99RPHRP-101081Local Maximum CID 3488 Min/Max/Mean This context group contains modifiers that indicate whether the measurement is a minimum, maximum or averaged value. Context ID 3488 Min/Max/Mean Type: Extensible Version: 20040614 Code SchemeCode ValueConcept NameSRTG-A437MaximumSRTR-404FBMinimumSRTR-00317Mean CID 7473 General Area Calculation Methods Context ID 7473 General Area Calculation Methods Type: Extensible Version: 20070827 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)DCM122501Area of closed irregular polygonDCM122502Area of a closed NURBS CID 7474 General Volume Calculation Methods Context ID 7474 General Volume Methods Type: Extensible Version: 20070827 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)DCM122503Integration of sum of closed areas on contiguous slices CID RPH_7040 Region Segmentation Methods Context ID RPH_7040 Region Segmentation Methods Type: Extensible Version: 20090731 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTG-D221Manual99RPHRP-101030Random Walker 3D Notes: 1. This template should be extended as necessary to include categories (families) of tools as appropriate (as distinct from specific versions of specific algorithms), and pre-coordinate concepts such as 2D or 3D, threshold, connectivity or model based, etc. CID RPH_7041 Automation Context ID RPH_7041 Automation Type: Extensible Version: 20090402 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTG-D221ManualSRTG-D231Automated99RPHRP-101013Semi-automated CID RPH_7050a Adjudication Choice Reasons Context ID RPH_7050a Adjudication Choice Reasons Type: Extensible Version: 20090826 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)99RPHRP-100311Arbitrary choice99RPHRP-100312Agree with lesion selection99RPHRP-100313Agree new disease is unequivocal99RPHRP-100314Disagree new disease is unequivocal99RPHRP-100315New lesion identified may be an artifact99RPHRP-100316New lesion identified may be benign99RPHRP-100317New lesion identified may have been present at baseline99RPHRP-100318Agree progression of non-target disease is unequivocal99RPHRP-100319Disagree progression of non-target disease is unequivocal CID RPH_7050b Adjudication Discordance Reasons Context ID RPH_7050b Adjudication Discordance Reasons Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)Justifiable99RPHRP-100290Justifiable Difference in Lesion SelectionYes99RPHRP-100291Incorrect lesion selection No99RPHRP-100292Justifiable Difference in Number of Target Lesions Identified at Baseline Yes99RPHRP-100293Incorrect Number of Target Lesions Identified at BaselineNo99RPHRP-100294Missing Image Data Led to a Justifiable Difference Between the ReadersYes99RPHRP-100295One Reader Did Not Follow the CharterNo99RPHRP-100296Justifiable Perception Difference in Determining New LesionsYes99RPHRP-100297Incorrect Perception Difference in Determining New LesionsNo99RPHRP-100298Justifiable Perception Difference in Determining Progression on the Basis of Non-Target LesionsYes99RPHRP-100299Incorrect Perception Difference in Determining Progression on the Basis of Non-Target Lesions No99RPHRP-100300Justifiable Perception Difference in Lesion Measurements Yes99RPHRP-100301Incorrect Perception Difference in Lesion MeasurementsNo99RPHRP-100305Justifiable Difference in qualitative lesion assessmentYes99RPHRP-100306Incorrect qualitative lesion assessmentNo99RPHRP-100307Justifiable difference in anatomic correlation of lesionYes99RPHRP-100308Incorrect anatomic correlation of lesionNo99RPHRP-100309Justifiable Difference in Lesion SegmentationYes99RPHRP-100310Incorrect Lesion SegmentationNo CID RPH_7052 Adjudication Observation Scope Context ID RPH_7052 Adjudication Observation Scope Type: Extensible Version: 20090916 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)99RPHRP-100278Current TimePoint99RPHRP-100279Current and all previous TimePoints CID RPH_7060 Message Digest Algorithms Context ID RPH_7060 Message Digest Algorithms Type: Extensible Version: 20090211 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)99RPHRP-100883MD599RPHRP-100884SHA199RPHRP-100885RIPEMD160 CID RPH_7070 Closed Curve Types Context ID RPH_7070 Closed Curve Types Type: Extensible Version: 20090213 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)99RPHRP-100898Spline CID RPH_7071 Closed Polygon Types Context ID RPH_7071 Closed Polygon Types Type: Extensible Version: 20090213 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTG-A159Rectangle CID RPH_7080 Procedures Reported Context ID RPH_7080 Procedures Reported Type: Extensible Version: 20090213 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)Include CID RPH_7081 NM Procedures ReportedInclude CID RPH_7082 MR Procedures ReportedInclude CID RPH_7083 BMD Procedures Reported CID RPH_7081 NM Procedures Reported Context ID RPH_7081 NM Procedures Reported Type: Extensible Version: 20090213 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTP5-D1010Bone ScanSRTP5-D30FAMUGA99RPHRP-100905SestamibiSRTP5-D2500Ventilation/Perfusion CID RPH_7082 MR Procedures Reported Context ID RPH_7082 MR Procedures Reported Type: Extensible Version: 20090213 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTP5-09042Spectroscopy CID RPH_7083 BMD Procedures Reported Context ID RPH_7083 BMD Procedures Reported Type: Extensible Version: 20090213 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)99RPHRP-100906Whole Body Composition CID RPH_7230 Yes-No Only Context ID RPH_7230 Yes-No Only Type: Non-extensible Version: 20090331 Coding Scheme DesignatorCode ValueCode MeaningSRTR-0038DYesSRTR-00339No CID RPH_7231 Yes-No-UE Context ID RPH_7231 Yes-No-UE Type: Non-extensible Version: 20110822 Coding Scheme DesignatorCode ValueCode MeaningSRTR-0038DYesSRTR-00339No99RPHRP-100044Unable to evaluate CID RPH_7601 Measurement Object Types Context ID RPH_7601 Measurement Object Types Type: Extensible Version: 20090702 Coding Scheme DesignatorCode ValueCode Meaning99RPHRP-100103Line Segment99RPHRP-100104Biorthogonal Line Segments99RPHRP-101016Triorthogonal Line Segments99RPHRP-100105AngleDCM111041OutlineSRTG-D705Volume99RPHRP-1001213D Geometric Object99RPHRP-100106Text Annotation99RPHRP-100111Measurements Derived From Other Measurements CID RPH_7602 3D Geometric Object Types Context ID RPH_7602 3D Geometric Object Types Type: Extensible Version: 20090702 Coding Scheme DesignatorCode ValueCode Meaning99RPHRP-100124Ellipsoid99RPHRP-100125Sphere99RPHRP-100126Circular cylinder99RPHRP-100127Elliptical cylinder CID RPH_7702 Multiplicity Context ID RPH_7702 Multiplicity Type: Non-extensible Version: 20090623 Coding Scheme DesignatorCode ValueCode MeaningSRTG-A224SingularSRTG-A445Multiple CID RPH_7710 Baseline Time Point Observation Types With Yes-No Answers Context ID RPH_7710 Baseline Time Point Observation Types With Yes-No Answers Type: Extensible Version: 20110822 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-101019Baseline fluid collection is present CID RPH_7711 Post-Baseline Time Point Observation Types With Yes-No Answers Context ID RPH_7711 Post-Baseline Time Point Observation Types With Yes-No Answers Type: Extensible Version: 20110822 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-101018Pseudo-progression CID RPH_7712 Post-Baseline Time Point Observation Types With Yes-No-UE Answers Context ID RPH_7712 Post-Baseline Time Point Observation Types With Yes-No-UE Answers Type: Extensible Version: 20110822 Coding Scheme Designator (0008,0102)XE (0008,0102)Code Value (0008,0100)XE (0008,0100)Code Meaning (0008,0104)XE (0008,0104)99RPHRP-101020Baseline fluid collection has increased99RPHRP-101021New fluid collection is present CID 29 Acquisition Modality This Context Group includes codes that may be used to identify an image or waveform acquisition modality, as used in Attribute Modality (0008,0060) of a Modality Worklist Scheduled Procedure Step or a Composite SOP Instance (see PS3.3). It generally corresponds to a class of diagnostic equipment, or to a specific acquisition function or technique in a device. This Context Group may be used as the value set for HL7 v2 Table 0259 (see HL7 v2.6 Chapter 8 Section 8.8.8.47). Note: This Context Group is not the complete set of codes that may appear in the Attribute Modality (0008,0060); these are only the codes associated with orderable acquisition processes (not post-processing). Context ID 29 Acquisition Modality Type: Extensible Version: 20081028 Coding Scheme Designatorxe (0008,0102)Code Valuexe (0008,0100)Code Meaning xe (0008,0104)DCMBMDBone Mineral DensitometryDCMBDUSUltrasound Bone DensitometryDCMEPSCardiac ElectrophysiologyDCMCRComputed RadiographyDCMCTComputed TomographyDCMDXDigital RadiographyDCMECGElectrocardiographyDCMESEndoscopyDCMXCExternal-camera PhotographyDCMGMGeneral MicroscopyDCMHDHemodynamic WaveformDCMIOIntra-oral RadiographyDCMIVUSIntravascular UltrasoundDCMMRMagnetic ResonanceDCMMGMammographyDCMNMNuclear MedicineDCMOCTOptical Coherence TomographyDCMOPMOphthalmic MappingDCMOPOphthalmic PhotographyDCMOPROphthalmic RefractionDCMOPTOphthalmic TomographyDCMOPVOphthalmic Visual FieldDCMPXPanoramic X-RayDCMPTPositron emission tomographyDCMRFRadiofluoroscopy DCMRGRadiographic imagingDCMSMSlide MicroscopyDCMUSUltrasoundDCMXAX-Ray Angiography CID 230 Yes-No Context ID 230 Yes-No Type: Non-extensible Version: 20060613 Coding Scheme DesignatorCode ValueCode MeaningSRTR-0038DYesSRTR-00339NoSRTR-0038AUndetermined CID 244 Laterality Context ID 244 Laterality Type: Non-Extensible Version: 20030108 Coding Scheme Designator (0008,0102)Code Value (0008,0100)xe (0008,0100)Code Meaning (0008,0104)xe (0008,0104)SRTG-A100RightSRTG-A101LeftSRTG-A102Right and leftSRTG-A103Unilateral Code Definitions Code Definitions (Coding Scheme Designator 99RPH Coding Scheme Version 01) Code Valuexe (0008,0100)Code Meaningxe (0008,0104)DefinitionNotesRP-100001Clinical Trial ResultsDocument title for clinical trial results.RP-100002ReaderPerforming role that involves reading data or images of any type.RP-100003Eligibility ReaderPerforming role that involves evaluating data or images of any type against defined criteria for the purpose of establishing eligibility to be enrolled in a clinical trial.RP-100004AdjudicatorPerforming role that involves an adjudicator comparing the work performed by other readers and accepting or rejecting their results (response assessments).RP-100005ReviewerPerforming role that involves reviewing the work performed by other readers for any purpose.RP-100006Person Observers Login NameLogin name (user ID) of human observer that created the observations.Contrast with (121008,DCM,Person Observer Name)RP-100007Identifier within Person Observers RoleA numeric or alphabetic designator of an individual within a role.E.g., 1 or 2, or A or B; should not recapitulate the role (i.e., should not be READER1), since it is used in conjunction with a separate coded concept for the role itself.RP-100008Worklist Task NameThe name of the worklist task that was selected to initiate the reading session for the subject. E.g., this might be to read all of the available time points for the subject.RP-100009Worklist Sub-task NameThe name of the worklist sub-task within the worklist task that was selected to initiate the reading sub-task for the subject. E.g., this might be a sub-task to read the current time point in comparison with previous time points in a sequential read.RP-100010Worklist Task VersionThe version of the task identified by the Worklist Task UID.RP-100011Worklist Task DescriptionA description of the task.RP-100012Last Modifying Person Observers Login NameLogin name (user ID) of human observer that last modified the observations.RP-100017Protocol Time Point Unique IdentifierAn identifier of the time point, which is unique within a appropriate local context (such as an entire organization, system or protocol), which identifies the time point slot within a protocol. I.e., all of the subjects within a protocol that are examined at a particular scheduled time point (e.g., baseline) time point will have the same Protocol Time Point Unique Identifier, but different Subject Time Point Unique Identifiers. However, in different protocols, the Protocol Time Point Unique Identifiers for the same conceptual time point will be different. E.g., the baseline time point will have different Protocol Time Point Unique Identifiers in different protocols.This is a unique identifier in a generic sense, but not encoded as a DICOM (dotted numeric) UID. It is not intended to be human-readable.RP-100018Subject Time Point Unique IdentifierAn identifier of the time point, which is unique within an appropriate local context (such as an entire organization, system or protocol), which identifies the actual time point during which a particular subject was examined. This is a unique identifier in a generic sense, but not encoded as a DICOM (dotted numeric) UID. It is not intended to be human-readable.RP-100019Time Point NameA name for a time point, such as may be displayed to the user during a reading session. E.g., TP0.RP-100021Time Point UnscheduledWhether or not a time point was unscheduled.RP-100022Time Point BaselineWhether or not a time point was the baseline time point. E.g., in RECIST, the time point at which target and non-target lesions are selected.RP-100023Reading Sub-taskInformation about the lowest level of a workflow performed during a read, e.g., the reading of a single time point in comparison with its predecessors in a sequential read.RP-100024Time PointInformation about a single time point, e.g., the results of analysis of images obtained within a certain temporal window around a significant clinical event, such as a cycle of chemotherapy.RP-100025LesionA localized area of diseased or disordered tissue.RP-100026Lesion TypeThe type of lesion, as defined by the response criteria. E.g., in RECIST, a target lesion.RP-100027Lesion Type ModifierThe modifier of the type of lesion, e.g., a measurement for a non-target lesion to establish progression.RP-100028Predecessor Lesion Tracking Unique IdentifierA reference to a lesion on a previous time point used when lesions split or merge.RP-100029Target LesionA lesion that consists of measurable disease.Always designated on the baseline time point, but may be found on the original read, or flagged with as an additional lesion on subsequent review.RP-100030Non-target LesionA lesion that consists of disease that is not measured or measurable.Always designated on the baseline time point, but may be found on the original read, or flagged with as an additional lesion on subsequent review.RP-100031New lesionA lesion that was not present on the baseline time point.RP-100032Retired not to be used.RP-100033Retired not to be used.RP-100034Include FlagWhether or not a geometric sub-region of interest is included or excluded from the definition of the location of a lesion.RP-100035Background lesionA lesion used to as the background for a computation derived from another lesion.May be used for an entire timepoint, or for a specific lesion computation, or both.RP-100036Reconstruction Interval Unknown But Sufficient For Lesion SelectionThe reconstruction interval of the images on which a lesion (e.g., target lesion) is being measured is unknown, but the reader has determined ( e.g., by visual inspection) that the reconstruction interval is sufficient to select the lesion.E.g., used when the user has overriden rules related to minimum lesion size relative to reconstruction interval.RP-100041LR Lesion RemovedA lesion cannot be evaluated because the lesion itself or the organ containing it has been removed (e.g., surgically)RP-100042Unable to evaluate lesionWhether or not a lesion can be evaluatedThe concept name of a yes-no questionRP-100043Reason unable to evaluateRP-100044Unable to evaluateThe subject of the concept cannot be evaluatedThe value of a concept with a yes-no-UE CID.RP-100045Lesion obscuredThe location of the lesion is obscured (e.g., by artifact).RP-100046Improper field of viewThe field of view of images at the current time point is too small to provide adequate anatomic coverage.RP-100047Missing windowThere are no images with the required window center and width at the current time point (i.e., for scanned printed film of digital modalities).RP-100048Missing or inconsistent contrast agent or phaseThe imaging study does not contain images with the appropriate IV and/or oral contrast, or does not contain images with the required contrast phase, or contains contrast phases that are different from those used previously.RP-100049Not distinguishable from other lesionsA lesion is not distinguishable from other lesions.RP-100050Change in reconstruction method or parametersThe method (algorithm) or the parameters of the algorithm (other than reconstruction interval) used to reconstruct images from the acquired raw data is different.E.g., for PET,filtered backprojection or iterative reconstruction, the number of iterations, etc., may have changed. For CT, a different reconstruction kernel (e.g., bone or high frequency rather than soft tissue) may have changed.RP-100051Change in reconstruction intervalThe reconstruction interval (distance between the centers of adjacent slices) is different in the current study is from that used previously.RP-100052Modality changedThe modality used is different in the current study from that used previously.RP-100053Unable to measure lesionRP-100054Reason unable to measureRP-100055Too small to measureA lesion is too small to measure, based on the clinical trial protocol criteria.RP-100056Lesion resolvedA lesion cannot be measured because it has completely resolved.RP-100057Lesion removedA lesion cannot be measured because it has been removed (e.g., surgically resected).RP-100058Edit ReasonThe reason an observation has been edited (added or changed).RP-100059DCF correctionData Clarification Form i.e., the catch all for any correction that is not specified by another more detailed reason.RP-100060Correction based on CMO reviewRP-100061Lesion did not meet qualification requirementsE.g. a target did not meet size criteriaRP-100062Lesion identified was artifactRP-100063Lesion identified was benignRP-100064Image quality issue lesion not clearly seenRP-100065Inter-current disease lesion not clearly seenRP-100066Lesion incorrectly measuredRP-100067New bone lesion result of flare phenomenonRP-100068Lesion was present previously but not IdentifiedRP-100069Lesion was in previously irradiated fieldRP-100070New images presentedRP-100071New clinical data presentedRP-100072Measuring a non-target lesion to justify progressionRP-100073Time point observationObservation about an entire time point, as opposed to a single lesion; e.g., user entered comments about the time point.RP-100074Signature meaningMeaning of (reason for) the electronic signature (e.g., per 21 CFR part 11.50 (a)(3)).RP-100075Lesion unmeasurableA lesion is unmeasureable without a specified reasonE.g., may be too diffuse.RP-100076Source measurement changedE.g., the derived SLD changed because one of the lesion LDs changed.RP-100081Worklist Task UIDA unique identifier for each worklist taskRP-100082Worklist Sub-task UIDA unique identifier for each worklist sub-taskRP-100083VersionThe version identifier assigned by a manufacturer, author or organization to a specific entity, e.g., a software application, algorithm, set of rules, configuration, etc.RP-100084Application NameThe name assigned by a manufacturer to a specific software application (e.g., a plug-in).RP-100085Algorithm TypeThe family (class) to which an algorithm belongs.RP-100086Business Rule Set NameThe name assigned by a manufacturer, author or organization to a set of business rules that dictate application behavior at various trigger points.RP-100087Segmentation algorithmA type of algorithm that performs segmentation of an image.RP-100088Registration algorithmA type of algorithm that performs registration between sets of images.RP-100089Propagation algorithmA type of algorithm that performs propagation of locations between sets of images.RP-100090CompletedA flag indicating whether or not an entity has been completed within some application-specific context (e.g., if a time point, or lesions in a time point, have been completed (i.e., locked)). This may indicate that any subsequent changes need to be detected and recorded in an audit trail.RP-100100Region RasterPurpose of reference for an IMAGE content item that references a Segmentation Instance that encodes a raster of the voxels defining the region of a finding or featurePurpose of Reference for content item of value type IMAGERP-100102Image Sub-regionRP-100103Line SegmentA single straight line segment defined by two end-points.RP-100104Biorthogonal Line SegmentsTwo straight line segments perpendicular to each other, each defined by two end-points.RP-100105AngleThe angle between two lines defined by two line segments.RP-100106Text AnnotationA graphic annotation consisting of a text message that is applied to a location on an image.RP-100107Standardized Uptake Value body weight RP-100108Standardized Uptake Value lean body massRP-100109Standardized Uptake Value body surface areaRP-100110Tumor to background ratioRP-100111Measurements Derived From Other MeasurementsA measurement that is computed from other lesions, regions, or measurementRP-100112Source Measurement Object UIDThe UID of a measurement object that is used as the source for a measurement derived from other measurements.RP-100120Angle Line SegmentA line segment is one of two that defines an angle.RP-1001213D Geometric ObjectThe cross section that defines a 3D geometric object.RP-100122First Extent of 3D Geometric ObjectOne extent of the normal to the cross section of a 3D geometric object.RP-100123Second Extent of 3D Geometric ObjectA second extent of the normal to the cross section of a 3D geometric object.RP-100124EllipsoidRP-100125SphereRP-100126Circular cylinderRP-100127Elliptical cylinderRP-1001283D Geometric Object TypeRP-100130Lesion segmentation cannot be performedRP-100131Attenuation Correction map not availableRP-100132Attenuation Correction map technically limitedRP-100133Poor count statisticsRP-100134Not distinguishable from normal physiologic activityRP-100135Parameter(s) required for SUV calculation not providedRP-100140Product of Short and Long AxesThe product of the short and long diameters of a biorthogonal measurement.This is the area of a rectangle enclosing the biorthogonal measurement,RP-100141Product of Short and Long and Normal AxesThe product of the short and long and normal diameters of a triorthogonal measurement.This is the area of a cuboid enclosing the biorthogonal measurement,RP-100142Sum of the Longest Diameters (SLD)The sum of the long diameters of all the target lesions in a time point.RP-100143Sum of the Product of the Short and Long Diameters (SPD)The sum of the product of the short and long diameters of the biorthogonal measurements of all the target lesions in a time point.RP-100144Change in Sum of the Longest Diameters (SLD) from NadirThe relative change in the SLD from the time point with the least amount of disease (nadir) to the current time point.RP-100145Change in Sum of the Product of the Short and Long Diameters (SPD) from NadirThe relative change in the SPD from the time point with the least amount of disease (nadir) to the current time point.RP-100146Change in Sum of the Longest Diameters (SLD) from BaselineThe relative change in the SLD from the baseline time point to the current time point.RP-100147Change in Sum of the Product of the Short and Long Diameters (SPD) from BaselineThe relative change in the SPD from the baseline time point to the current time point.RP-100150DiscardedWhether or not an object (such as a lesion or measurement) that has previously been observed has been discarded (e.g., because it was subsequently found to be a normal anatomic finding rather than a lesion).RP-100210Worklist Task TypeThe type of worklist task. E.g., the type of read, such as a sequential read or an adjudication.RP-100211Worklist Task CategoryThe category of a worklist task. E.g., whether or not a sequential read is locked, or a substitute read.RP-100212Worklist Task LevelThe level of the task with respect to adjudication of multiple task performers work.E.g., original, level 1 adjudication (comparison), level 2 adjudication (reject and repeat).RP-100213Perform initial taskThe task level is that of performance of the original task.E.g., to perform the primary read.RP-100214Perform comparisonThe task level is that of comparing the work performed by other performers.E.g., to compare two readers results.RP-100215Repeat rejected taskThe task level is that of repeating the work of other performers that was rejected.E.g., all previous readers results were rejected during adjudication, and the adjudicator re-reads.RP-100220Sequential Locked ReadA task in which the performer will see the assigned time points in sequence and the measurements will be locked (can not be altered except with appropriate permissions and with an entered change reason).RP-100221Sequential Unlocked ReadA task in which the performer will see the assigned time points in sequence and the measurements will be unlocked (can alter measurement anytime without entering a change reason).RP-100222Non-sequential Unlocked ReadA task in which the performer will see all the time points together and measurements will be unlocked (can alter measurement anytime without entering a change reason).RP-100230Supplemental ReadA task in which an initial read has previously been completed for the time point and additional information has been received for the completed time point that requires that it be re-read.RP-100231Repeat ReadA task in which an initial read has previously been completed for the time point and the same time point needs to be re-read without a specified reason.RP-100232Worklist Task Repeat TypeThe reason why a task (read) is to be repeated for a previously completed time pointRP-100233Worklist Task Variability TypeThe type of variability within or between performers that is being evaluated by a task.RP-100234Intraobserver variabilityThe purpose of the task is to evaluate variability in the results of the same performer on different occasions.This concept is present in MeSH, but that is not a formally recognized coding scheme in DICOM and no form of code defined.RP-100235Interobserver variabilityThe purpose of the task is to evaluate variability in the results of the different performers.This concept is present in MeSH, but that is not a formally recognized coding scheme in DICOM and no form of code defined.RP-100270PMD - Progressive metabolic diseaseAn increase in SUV of greater than 25% within the lesion defined on the baseline scan, visible increase in the extent of uptake (20% in the longest dimension) or the appearance of new uptake in metastatic lesions.As per Measurement of Clinical and Subclinical Tumour Response Using [18F]-uorodeoxyglucose and Positron Emission Tomography: Review and 1999 EORTC Recommendations in Eur J Cancer, Vol. 35, No. 13, pp. 17731782, 1999.RP-100271SMD - Stable metabolic diseaseAn increase in tumor SUV of less than 25% or a decrease of less than 15% and no visible increase in extent of uptake (20% in the longest dimension).RP-100272PMR - Partial metabolic responseReduction of a minimum of 1525% in SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle.RP-100273CMR - Complete metabolic responseComplete resolution of uptake within the lesion volume so that it was indistinguishable from surrounding normal tissue.RP-100277Observation ScopeThe scope to which an observation applies.E.g., whether an adjudication observation applies to one time point or a time point and all its predecessors.RP-100278Current TimePointRP-100279Current and all previous TimePointsRP-100280Adjudication ObservationThe result of comparison of two or more performers results.RP-100281Observers AcceptedWhich observers were chosen from the choices available.RP-100282Observers RejectedWhich observers were chosen from the choices available.RP-100283Reason for ChoiceThe reason for a choice.E.g., of one observer over others during a comparison (adjudication) of results.RP-100284Reason for DiscordanceThe reason why two or more sets of observations are not in agreementE.g., if two readers results differ during a comparison (adjudication).RP-100285Unequivocal ProgressionProgression is unequivocal when measurement is required but unable to measureRP-100286Adjudication Choice Impacted by Image QualityOne of the reasons why two or more sets of observations are not in agreement is the quality of the images.RP-100290Justifiable Difference in Lesion SelectionRP-100291Incorrect lesion selection RP-100292Justifiable Difference in Number of Target Lesions Identified at Baseline RP-100293 Incorrect Number of Target Lesions Identified at BaselineRP-100294 Missing Image Data Led to a Justifiable Difference Between the ReadersRP-100295One Reader Did Not Follow the CharterRP-100296Justifiable Perception Difference in Determining New LesionsRP-100297Incorrect Perception Difference in Determining New LesionsRP-100298Justifiable Perception Difference in Determining Progression on the Basis of Non-Target LesionsRP-100299 Incorrect Perception Difference in Determining Progression on the Basis of Non-Target Lesions RP-100300 Justifiable Perception Difference in Lesion Measurements RP-100301 Incorrect Perception Difference in Lesion MeasurementsRP-100302RetiredRP-100303RetiredRP-100304RetiredRP-100305Justifiable Difference in qualitative lesion assessmentPETRP-100306Incorrect qualitative lesion assessmentPETRP-100307Justifiable difference in anatomic correlation of lesionPETRP-100308Incorrect anatomic correlation of lesionPETRP-100309Justifiable Difference in Lesion SegmentationRP-100310Incorrect Lesion SegmentationRP-100311Arbitrary choiceRP-100312Agree with lesion selection RP-100313Agree new disease is unequivocalRP-100314Disagree new disease is unequivocalRP-100315New lesion identified may be an artifactRP-100316New lesion identified may be benignRP-100317New lesion identified may have been present at baselineRP-100318Agree progression of non-target disease is unequivocalRP-100319Disagree progression of non-target disease is unequivocalRP-100320CalibrationIs the entity a calibration object or not.RP-100330Radiology Read PerformedRP-100331Adjudication level 1 PerformedRP-100332Adjudication level 2 PerformedRP-100333Corrections PerformedRP-100334Eligibility Read PerformedRP-100335Oncology Read Performed RP-100336PET Read PerformedRP-100337RetiredRP-100338RetiredRP-100339RetiredRP-100340Nuclear Medicine Review PerformedRP-100341CT + PET Read PerformedRP-100342CMO Review PerformedRP-100343Read Result Quality Control PerformedRP-100344Image Quality Control PerformedRP-100350Correction to lesion labelRP-100351RecalibrationRP-100401Observation UIDA globally unique identifier of an observation.Each observation has a unique identifier (even if it is the same type of observation of, for example, the same subject at a different time point); when an existing observation is edited, it retains the same UID.RP-100402Observation TypeThe type of observation.RP-100403Measurement Object UIDA globally unique identifier of a measurement object.Measurement objects of the same lesion at a different time point will have different UIDs; when an existing measurement object is edited, it retains the same UID.RP-100410Pixel CountA count of the number of pixels or voxels in a region or sub-region.RP-100500New Lesion CommentA comment in a Timepoint Observation that is about New Lesions that are not encoded as Lesion Observations.RP-100501Non-Target Lesion CommentA comment in a Timepoint Observation that is about Non-Target Lesions that are not encoded as Lesion Observations.RP-100502Measurement ObjectA region, measurement or annotations made on one or more images for the purpose of defining or describing lesions.RP-100503Measurement Object TypeThe type of measurement object.RP-100504RetiredRP-100550Time Point Sponsor NameThe Time Point name provided by the sponsor. Hidden from the reader in some protocols.RP-100551Time Point TypeCategorizes a time point as whether it is scheduled, unscheduled or follow-upRP-100552Days from enrollmentNumber of days from enrollment - used to determine the relative sequence of time points. Typically, it is zero for baseline. For some studies, it can have a negative value for pre-study time points.RP-100553Time Point OrderA number indicating the temporal reading order of the described time point relative to other time points in the same read.RP-100600Acquisition DateThe date the acquisition of data started that resulted in an image that is used for measurement or response assessment.RP-100601Acquisition Date AliasAn alias of the date the acquisition of data started that resulted in an image that is used for measurement or response assessment.RP-100700Registration UsedA reference to the registration object(s) used in the context of an observation.RP-100702General lesion observationsObservations made about lesions in that are not specific to time pointRP-100800RadiologyA type of worklist that is to perform a Radiology read.RP-100801OncologyA type of worklist that is to perform an Oncology read.RP-100802PETA type of worklist that is to perform a PET read.RP-100803Eligibility RadiologyA type of worklist that is to perform a Radiology Eligibility read.RP-100804Eligibility OncologyA type of worklist that is to perform an Oncology Eligibility readRP-100805Eligibility Non-OncologyA type of worklist that is to perform a Non-Oncology Eligibility readRP-100806Non-Oncology PhotoA type of worklist that is to perform a Non-Oncology Photo readRP-100807Radiology/PETA type of worklist that is to perform a combined Radiology/PET readE.g., read both the CT and the PET at the same time.RP-100808OverallA type of worklist that is to perform an Overall readRP-100809ReviewA type of worklist that is to perform a ReviewIncluding a CMO ReviewRP-100810RTQAA type of worklist that is to perform a Radiotherapy Quality Assurance Read.RP-100811Individual RandomizedA type of worklist that is to perform a Radiology read in which each time point for a subject is read in random order.RP-100812Comparison RandomizedA type of worklist that is to perform a Radiology read in which pairs of time points to be compared for a subject are read in random order.RP-100880RetiredRP-100881Message DigestA short piece of information used to detect changes to an object.Usually constructed using a cryptographic hash function.RP-100882Message Digest AlgorithmAn algorithm producing a Message Digest.Usually a cryptographic hash function.RP-100883MD5The MD5 Message Digest Algorithm.RP-100884SHA1The SHA1 Message Digest Algorithm.RP-100885RIPEMD160The RIPEMD160 Message Digest Algorithm.RP-100886Message Digest ScopeThe scope of object contents included when computing the Message Digest.RP-100887Entire fileThe entire PS 3.10 DICOM File is included as a byte stream.No attempt is made to normalize or canonicalize the same meaning in different transfer syntaxes, or to exclude the meta-information header or other structural elements like group lengths.RP-100897Closed Polygon TypeThe type of geometric shape defined by points encoded as a closed polygon.RP-100898SplineRP-100899Closed Curve TypeThe type of curve defined by control points encoded as a closed polygon.RP-100900PET Radionuclide Incubation TimeThe time between the start of injection of the PET radionuclide and the start of acquisition of the PET data.RP-100901Qualitative AssessmentThe qualitative (rather than quantitative) assessment of the state of an entity (such as a lesion) at a single point in time.This is distinct from a (therapeutic) response assessment, which implies a comparison between states at two time points (e.g., of a lesion between previous and current time point)RP-100902Positive PET FindingA focal or diffuse FDG uptake above background in a location incompatible with normal anatomy/physiology, by visual assessment.I.e., a qualitative, not quantitative, assessment. As per Juweid et al. J Clinical Oncology 255 2007. Use of Positron Emission Tomography for Response Assessment of Lymphoma: Consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma.RP-100903Negative PET FindingAbsence of a focal or diffuse FDG uptake above background in a location incompatible with normal anatomy/physiology, by visual assessment.RP-100904Exam IdentifierThe local identifier of an exam, which is a set of images that were acquired for a particular purpose, is a distinct organization from a DICOM Study and a DICOM Series.One exam may involve multiple Studies or multiple Series, or a single Series may span multiple Exams (e.g., a CT Chest Exam and a CT Abdomen Exam performed as one Series in one Study).RP-100905SestamibiA procedure using Tc99m MIBINot specified as to whether for parathyroid localization, myocardial blood flow or mass malignancy assessment.RP-100906Whole Body CompositionA procedure to assess whole body composition using Dual energy X-ray absorptiometry (DXA)RP-100920Observation Creation DateTimeThe date and time that an observation was createdRP-100921Observation Modification DateTimeThe date and time that an observation was modified.RP-100922Additional ObservationA flag to indicate that an observation was added retrospectively.I.e., after the entity about which the observation was made completed (e.g., on reviewing a time point retrospectively, and additional target lesion was added).RP-100923Edit CommentA comment about an edit (addition or change) to an observation.RP-100924Worklist Sub-task Start DateTimeThe date and time that work on the sub-task first started.RP-100925Worklist Sub-task Closed DateTimeThe date and time that work on the sub-task last closed.Regardless of whether closed as complete or not.RP-100926Algorithm UIDA UID of an algorithmRP-100927Retired - not to be used.RP-100928Retired - not to be used.RP-100930Additional Seed Points UsedDuring a semi-automated segmentation, additional seed points were added by the user to modify the initial segmentation and the segmentation algorithm was repeated.RP-100931Outline Manually EditedAfter a semi-automated segmentation, the user manually edited the outline iof the segmentation.RP-100932Initial Segmentation StrokeThe end points of a stroke supplied by the user to initialize segmentation.RP-101001Region MeasurementA single measurement of an image region or sub-region.RP-101002Simple MeasurementA single measurement of simple geometric object.RP-101003Image RegionRP-101004Derived MeasurementA measurement derived from other measurements.RP-101010Creation InformationInformation about the creation of an observationRP-101011Modification InformationInformation about the modification of an observationRP-101012AutomationWhether or not a finding was made manually or automatically.E.g., an automatically determined biorthogonal measurement from a segmented volume, as opposed to manual placement of location by a human.RP-101013Semi-automatedPerformed automatically after initialization by a human, and with subsequent review and modification by a human.RP-101014Observation Addition DateTimeThe date and time that an additional observation was created.RP-101016Triorthogonal Line SegmentsThree straight line segments perpendicular to each other, two of which are coplanar with an image plane and defined by two end-points, and the third defined by points on images at the upper and lower extent normal to the image plane.RP-101017Normal AxisThe length of a line segment in the axis perpendicular to an image plane.Used in triothogonal measurements together with short axis and long axis.RP-101018Pseudo-progressionApparent progression of disease after treatment caused by an artifact of the treatment.E.g., size increase caused by edema rather than proliferation of neoplasm.RP-101019Baseline fluid collection is presentWhether or not a fluid collection is present at baselineRegardless of whether it can be determined to be benign or malignantRP-101020Baseline fluid collection has increasedWhether or not a fluid collection that was present at baseline has increased or not.Regardless of whether it can be determined to be benign or malignantRP-101021New fluid collection is presentWhether or not a new fluid collection is present on a post-baseline time point that was not present at baseline.Regardless of whether it can be determined to be benign or malignantRP-101030Random Walker 3DA semi-automated 3D segmentation techniqueRP-101031DesignatorPerforming role that involves designating lesions for others to measure or interpret.RP-101032Adjudicator Repeating ReadPerforming role that involves an adjudicator who disagreed with all previous readers interpretations repeating the read themselves.RP-101033Quality Control - ImagesPerforming role that involves reviewing images to evaluate their compliance with quality criteria.RP-101034Quality Control - ResultsPerforming role that involves reviewing results to evaluate their compliance with quality criteria.RP-101035Eligibility AdjudicatorPerforming role that involves an adjudicator comparing the work performed by other eligibility readers and accepting or rejecting their eligibility assessments.RP-101036Adjudicator Repeating Eligibility ReadPerforming role that involves an adjudicator who disagreed with all previous eligibility readers interpretations repeating the eligibility read themselves.RP-101037Quality Control - Radiotherapy PlanPerforming role that involves reviewing radiotherapy plans to evaluate their compliance with quality criteria.RP-101040Radiology ReaderPerforming role that involves reading radiology images of any type.Some protocols involve this role alone, or preceeding those of another role such as a Post-Radiology PET Reader or a Post-Radiology Oncology ReaderRP-101041Post-Radiology PET ReaderPerforming role that involves reading PET images after a preceeding read of other radiology images has been performed.RP-101042Oncology ReaderPerforming role that involves reading oncology data of any type.May include skin lesion photographs of tumors (contrast with Photography Reader)RP-101043Post-Radiology Oncology ReaderPerforming role that involves reading oncology data of any type after a preceeding read of radiology images has been performed.RP-101044Non-Oncology Photography ReaderPerforming role that involves reading photographic images other than for oncology.E.g., dermatology, diabetic lesions.RP-101045Radiology AdjudicatorPerforming role that involves an adjudicator comparing the work performed by other radiology readers and accepting or rejecting their results (response assessments).RP-101046Oncology AdjudicatorPerforming role that involves an adjudicator comparing the work performed by other oncology readers and accepting or rejecting their results (response assessments).RP-101047Adjudicator Repeating Radiology ReadPerforming role that involves an adjudicator who disagreed with all previous radiology readers interpretations repeating the read themselves.RP-101048Adjudicator Repeating Oncology ReadPerforming role that involves an adjudicator who disagreed with all previous oncology readers interpretations repeating the read themselves.RP-101049Eligibility Radiology ReaderPerforming role that involves evaluating radiology images against defined criteria for the purpose of establishing eligibility to be enrolled in a clinical trial.RP-101050Eligibility Oncology ReaderPerforming role that involves evaluating oncology data or images against defined criteria for the purpose of establishing eligibility to be enrolled in a clinical trial.RP-101051Eligibility Radiology AdjudicatorPerforming role that involves an adjudicator comparing the work performed by other eligibility radiology readers and accepting or rejecting their eligibility assessments.RP-101052Eligibility Oncology AdjudicatorPerforming role that involves an adjudicator comparing the work performed by other eligibility oncology readers and accepting or rejecting their eligibility assessments.RP-101053Adjudicator Repeating Eligibility Radiology ReadPerforming role that involves an adjudicator who disagreed with all previous eligibility radiology readers interpretations repeating the eligibility read themselves.RP-101054Adjudicator Repeating Eligibility Oncology ReadPerforming role that involves an adjudicator who disagreed with all previous eligibility oncology readers interpretations repeating the eligibility read themselves.RP-101055PET ReaderPerforming role that involves reading PET images.RP-101056PET AdjudicatorPerforming role that involves an adjudicator comparing the work performed by other PET readers and accepting or rejecting their results (response assessments).RP-101057Adjudicator Repeating PET ReadPerforming role that involves an adjudicator who disagreed with all previous PET readers interpretations repeating the eligibility read themselves.RP-101080Local MeanThe mean value of voxels within an ROI that includes a designated centroid and a local volume of defined extent.E.g., an ROI of defined size around the maximum SUV as a centroid and the same sized ROI in the slice above and below.RP-101081Local MaximumThe maximum value of voxels within an ROI that includes a designated centroid and a local volume of defined extent.E.g., an ROI of defined size around the maximum SUV as a centroid and the same sized ROI in the slice above and below.RP-101090Input URLThe URL from which the image that is referenced was loaded. Usually a parent directory that is recursively traversed rather than a file-specific path.RP-101100Protocol NameThe name of the protocol.RP-101101Protocol UIDThe unique identifier of the protocol.RP-101102Site UIDThe unique identifier of the site.RP-101103Subject UIDThe unique identifier of the subject.RP-101104Enrollment DateThe date the subject was enrolled in the protocol.RP-101105Randomization DateThe date the subject was randomized in the protocol.RP-101106First Dose DateThe date of administration of the first dose of treatment.RP-101107End of Treatment DateThe date that treatment ended.RP-101108Termination DateThe date that subject participation in the protocol was terminated.RP-101109Protocol NumberThe number of the protocol. DICOM SR Header ATTRIBUTES Each DICOM SR Instance consists of a header that contains attributes that describe the instance (i.e., meta-data), and a content tree that encodes the instantiation of the SR Templates. This section replicates the Comprehensive SR IOD from DICOM PS 3.3, together with all of the Modules included by that IOD, with a description of what values shall be used for each Attribute and where their values shall be obtained from or how they shall be derived. Where Modules or Attributes are not used, this is either indicated explicitly or by omission. Comprehensive SR IOD Module Table COMPREHENSIVE SR IOD MODULES IEModuleReferenceDICOM UsagePresence of ModulePatientPatientC.7.1.1MALWAYSSpecimen IdentificationC.7.1.2C - Required if the Observation Subject is a SpecimenNEVERClinical Trial SubjectC.7.1.3UALWAYSStudyGeneral StudyC.7.2.1MALWAYSPatient StudyC.7.2.2UNEVERClinical Trial StudyC.7.2.3UALWAYSSeriesSR Document SeriesC.17.1MALWAYSClinical Trial SeriesC.7.3.2UALWAYSFrame of ReferenceFrame of ReferenceC.7.4.1UNEVERSynchronizationC.7.4.2UNEVEREquipmentGeneral EquipmentC.7.5.1MALWAYSDocumentSR Document GeneralC.17.2MALWAYSSR Document ContentC.17.3MALWAYSSOP CommonC.12.1MALWAYS Patient Module PATIENT MODULE ATTRIBUTES Attribute NameTagTypeValue and SourcePatient's Name(0010,0010)xe "(0010,0010)"2Shall not be empty. Subject identifier from worklist. Notes: 1. This is the same as in the DICOM images used in the read, all of which should have the same value. 2. By convention, the Patients Name (0010,0010) and the Patient ID (0010,0020) have the same vaue for de-identified subjects. If no worklist, shall be copied from the Patients Name (0010,0010) in one of the images.Patient ID(0010,0020)xe "(0010,0020)"2Subject ID from worklist. Shall be the same as Clinical Trial Subject ID (0012,0040). Notes: This is the same as in the DICOM images used in the read, all of which should have the same value. If no worklist, shall be copied from the Patient ID (0010,0020) in one of the images.Patient's Birth Date(0010,0030)xe "(0010,0030)"2Zero length value (empty).Patient's Sex(0010,0040)xe "(0010,0040)"2Zero length value (empty). No other Attributes of this Module shall be present. Clinical Trial Subject Module  TC Table C.2-5Clinical Trials Identification Module CLINICAL TRIAL SUBJECT MODULE ATTRIBUTES Attribute NameTagTypeValue and SourceClinical Trial Sponsor Name(0012,0010) XE "(0012,0010)" 1Protocol Sponsor Name from worklist. If no worklist, shall be RadPharm, Inc..Clinical Trial Protocol ID(0012,0020) XE "(0012,0020)" 1Protocol ID from worklist. If no worklist, shall be 0000.Clinical Trial Protocol Name(0012,0021) XE "(0012,0021)" 2Zero length value (empty). See Row 1 in TID RPH_0002c instead.Clinical Trial Site ID(0012,0030) XE "(0012,0030)" 2Shall not be empty. SiteID from worklist. If no worklist, shall be 0000.Clinical Trial Site Name(0012,0031) XE "(0012,0031)" 2Zero length value (empty).Clinical Trial Subject ID(0012,0040) XE "(0012,0040)" 1CShall not be empty. Shall be the same as Patient ID (0010,0020). Subject ID from worklist. If no worklist, shall be copied from the Patient ID (0010,0020) in one of the images.Clinical Trial Subject Reading ID(0012,0042) XE "(0012,0042)" 1CSubject ID from worklist. If no worklist, shall be Zero length value (empty). Note: Historically, there has been variation in the form of the subject identifier used; sometimes it includes the clinical site and sometimes it does not. Likewise, sponsors vary in the form of the identifier used in communications.  No other Attributes of this Module shall be present. General Study Module GENERAL STUDY MODULE ATTRIBUTES Attribute NameTagTypeValue and SourceStudy Instance UID(0020,000D)xe "(0020,000D)"1Each Sub-Task is its own new DICOM Study, and hence the Study Instance UID will be generated the first time a Sub-Task is started. Successive incomplete and the final complete and any later edited SR instances for the same Sub-Task shall be in the same Study (e.g., can be copied from the previous SR instance for the same sub-task when it is re-loaded).Study Date(0008,0020)xe "(0008,0020)"2The date of the Timepoint for the Sub-Task (if there is only one), or the most recent Timepoint for the Sub-Task (if there is more than one, such as in an unlocked read). Since time points do not have a single date per se (not in the worklist), the Study Date of the first (earliest) image Study in the most recent time point shall be used. If no worklist, and time point information is present in the image headers, the Study Date of the first (earliest) image Study in the most recent time point shall be used. If no worklist, and no time point information is present in the image headers, the Study Date of the first (earliest) image Study loaded shall be used. If no value available from the image headers, shall be zero length.Study Time(0008,0030)xe "(0008,0030)"2A fixed value of 000000.Referring Physician's Name(0008,0090)xe "(0008,0090)"2Zero length value (empty).Study ID(0020,0010)xe "(0020,0010)"2The same value as used for the Study Date (0008,0020) (which may be zero length if no value available from the image headers).Accession Number(0008,0050)xe "(0008,0050)"2Zero length value (empty).Study Description(0008,1030)xe "(0008,1030)"3The text value of the Worklist Sub-task Title. If no worklist, shall be zero length (empty).Name of Physician(s) Reading Study(0008,1060)xe "(0008,1060)"3Shall be absent - the user identifiers are conveyed in other attributes and content items. No other Attributes of this Module shall be present. Clinical Trial Study Module  TC Table C.2-5Clinical Trials Identification Module CLINICAL TRIAL STUDY MODULE ATTRIBUTES Attribute NameTagTypeValue and SourceClinical Trial Time Point ID(0012,0050) XE "(0012,0050)" 2Subject Time Point UID from the worklist of the single Time Point in the Study, or the most recent Time Point in the Study if more than one. If no worklist, shall be zero length (empty).Clinical Trial Time Point Description(0012,0051) XE "(0012,0051)" 3Time Point Label from the worklist of the single Time Point in the Study, or the most recent Time Point in the Study if more than one. If no worklist, shall be zero length (empty). No other Attributes of this Module shall be present. Clinical Trial Series Module  TC Table C.2-5Clinical Trials Identification Module CLINICAL TRIAL SERIES MODULE ATTRIBUTES Attribute NameTagTypeValue and SourceClinical Trial Coordinating Center Name(0012,0060) XE "(0012,0060)" 2Shall be zero length.Clinical Trial Series ID(0012,0071) XE "(0012,0071)" 3Shall be absent.Clinical Trial Series Description(0012,0072) XE "(0012,0072)" 3Shall be absent. No other Attributes of this Module shall be present. SR Document Series Module SR DOCUMENT SERIES MODULE ATTRIBUTES Attribute NameTagTypeValue and SourceModality(0008,0060)xe "(0008,0060)"1Shall be SRSeries Instance UID(0020,000E)xe "(0020,000E)"1Each opening and re-opening of a Sub-Task is its own new DICOM Series, and hence the Series Instance UID will be generated at Sub-Task opening time. Successive incomplete and the final complete and any later edited SR instances for the same Sub-Task will be in different Series (since the work may be done on different equipment (workstations) and the DICOM rule is that different equipment must produce different series.). Series Number(0020,0011)xe "(0020,0011)"1Shall be 1 for the 1st opening of a sub-task, and incremented by one in instances for successive opening of the same sub-task. I.e., the instance corresponding to the latest sub-task opening will have the highest number. If no worklist, and previous SR instances exist, shall be incremented by for each new SR saved.Series Date(0008,0021)xe "(0008,0021)"3The Date in UTC the Sub-Task was opened, or if no worklist, the images were loaded.Series Time(0008,0031)xe "(0008,0031)"3The Time in UTC the Sub-Task was opened, or if no worklist, the images were loaded.Series Description(0008,103E)xe "(0008,103E)"3If the sub-task is completed, the string Completed, if the sub-task is not completed, the string Incomplete, if the sub-task has been edited after completion, the string Completed [Edited].Referenced Performed Procedure Step Sequence(0008,1111)xe "(0008,1111)"2Shall be an empty (zero length) sequence. No other Attributes of this Module shall be present. General Equipment Module GENERAL EQUIPMENT MODULE ATTRIBUTES Attribute NameTagTypeValue and SourceManufacturer(0008,0070)xe "(0008,0070)"2Shall be the manufacturer of the software (e.g., Siemens Corporate Research).Institution Name(0008,0080)xe "(0008,0080)"3Shall be RadPharm, Inc.Institution Address(0008,0081)xe "(0008,0081)"3Shall be absent.Station Name(0008,1010)xe "(0008,1010)"3Shall be the host name of the device obtained from the operating system.Institutional Department Name(0008,1040)xe "(0008,1040)"3Shall be absent.Manufacturer's Model Name(0008,1090)xe "(0008,1090)"3Shall be the software manufacturers model name (DIRS2).Device Serial Number(0018,1000)xe "(0018,1000)"3Shall be some identifier corresponding to the instance of the software being used (e.g. license number or similar).Software Versions(0018,1020)xe "(0018,1020)"3Shall be the software version of the installed instance of the software (and distinct from any other version; i.e., shall change if the software changes).Pixel Padding Value(0028,0120)xe "(0028,0120)"1CShall be absent. No other Attributes of this Module shall be present. SR Document General Module SR DOCUMENT GENERAL MODULE ATTRIBUTES Attribute NameTagTypeValue and SourceInstance Number(0020,0013)xe "(0020,0013)"1Shall always be 1.Completion Flag(0040,A491)xe "(0040,A491)"1Shall be PARTIAL if the sub-task is closed as incomplete, and COMPLETE if the sub-task is closed as complete.Completion Flag Description(0040,A492)xe "(0040,A492)"3Shall be absent.Verification Flag(0040,A493)xe "(0040,A493)"1Shall be UNVERIFIED if the sub-task is closed as incomplete, or is closed as complete but not signed. Shall be VERIFIED if the sub-task is closed as complete and signed.Content Date(0008,0023)xe "(0008,0023)"1The date in UTC on which the current sub-task was opened most recently (may not be the first time the sub-task was opened, i.e., it was started, if the sub-task was previously closed as incomplete), or if no worklist, the images were loaded.Content Time(0008,0033)xe "(0008,0033)"1The time in UTC at which the current sub-task was opened most recently (may not be the first time the sub-task was opened, i.e., it was started, if the sub-task was previously closed as incomplete), or if no worklist, the images were loaded.Verifying Observer Sequence(0040,A073)xe "(0040,A073)"1CShall be present if Verification Flag (0040,A493)xe "(0040,A493)" is VERIFIED. >Verifying Observer Name(0040,A075)xe "(0040,A075)"1Shall be the full name (not user id) of the user.>Verifying Observer Identification Code Sequence(0040,A088)xe "(0040,A088)"2Shall be present, with the userid as the Code Value, the full name as the Code Meaning, and the Coding Scheme Designator of 99RPH_USERS.>>Include 'Code Sequence Macro' Table 8.8-1No Baseline Context ID defined.>Verifying Organization(0040,A027)xe "(0040,A027)"1Shall be RadPharm, Inc.. >Verification DateTime(0040,A030)xe "(0040,A030)"1Shall be the UTC date and time that the Sub-Task was signedxe "(0040,A075)".Predecessor Documents Sequence(0040,A360)xe "(0040,A360)"1CShall be present and reference the SOP Instance UID of a single immediate predecessor document that was either an incomplete document that has been updated in the current Sub-task (though not necessarily completed), or a complete document that has been edited in the current Sub-Task. If this Attribute is present, exactly one Item shall be present. Note: The chain of successive incomplete and/or edited documents can be followed backwards by examining this attribute in the most recent document.>Include ' Hierarchical SOP Instance Reference Macro' Table C.17-3Identical Documents Sequence(0040,A525)xe "(0040,A525)"1CShall be absent.>Include ' Hierarchical SOP Instance Reference Macro' Table C.17-3Referenced Request Sequence(0040,A370)xe "(0040,A370)"1CShall be absent.Performed Procedure Code Sequence(0040,A372)xe "(0040,A372)"2Shall be an empty Sequence.>Include 'Code Sequence Macro' Table 8.8-1No Baseline Context ID Number is specified.Current Requested Procedure Evidence Sequence(0040,A375)xe "(0040,A375)"1CShall list all of the SOP Instances that are referenced in the content tree (i.e., those on which measurements are made, and not all SOP Instances that were used during the read).>Include ' Hierarchical SOP Instance Reference Macro' Table C.17-3Pertinent Other Evidence Sequence(0040,A385)xe "(0040,A385)"1CShall be absent.Referenced Instance Sequence(0008,114A) XE "(0008,114A)" 1CShall be absent. No other Attributes of this Module shall be present. SR Document Content Module The SR Document Content Module is not described in detail here, since its contents depend entirely on the templates used. There is no requirement that Observation DateTime (0040,A032) Attribute within the Document Relationship macro be used, since its purpose is subsumed in a more specific manner by content items in the TID RPH_0020 Audit Trail Entry template. The Container Macro, which is used from within the Document Content Macro is described here for two reasons: There is a requirement that for the top level container (i.e., the first row of the root template TID RPH_0001), that the Template Sequence (0040,a504) shall be present (see also  REF _Ref106182227 \h Templates section). The use of the Continuity of Content Attribute is constained to be SEPARATE (and not CONTINUOUS). Container Macro CONTAINER MACRO ATTRIBUTES Attribute NameTagTypeAttribute DescriptionContinuity of Content(0040,A050)xe "(0040,A050)"1Shall be SEPARATE.Content Template Sequence(0040,A504)xe "(0040,A504)"1CShall be present for the root content item (i.e., in the top level dataset). Shall be absent for all other content items.>Mapping Resource(0008,0105) XE "(0008,0105)" 1Shall be 99RPH.>Template Identifier(0040,DB00) XE "(0040,DB00)" 1Shall be RPH_0001. C.12.1 SOP Common Module Table C.12-1 SOP COMMON MODULE ATTRIBUTES Attribute NameTagTypeAttribute DescriptionSOP Class UID(0008,0016)xe "(0008,0016)"1Shall be the SOP Class UID for Comprehensive SR Storage SOP Class (1.2.840.10008.5.1.4.1.1.88.33).SOP Instance UID(0008,0018)xe "(0008,0018)"1Shall be uniquely generated for each instance. I.e., when a previous SR Instance for the same Sub-Task is loaded and edited, it shall be saved with a NEW SOP Instance UID (and the previous SOP Instance UID referenced as the single Item in Predecessor Documents Sequence (0040,A360)).Specific Character Set(0008,0005)xe "(0008,0005)"1CShall be ISO_IR 100 (to indicate all strings are 8 bit Latin 1 character set only, which includes US-ASCII in the lower 7 bits).Instance Creation Date(0008,0012)xe "(0008,0012)"3Shall be the Date in UTC this SOP Instance was created.Instance Creation Time(0008,0013)xe "(0008,0013)"3Shall be the Time in UTC this SOP Instance was created.Instance Creator UID(0008,0014)xe "(0008,0014)"3Shall be a UID of the instance of the software being used (unique to the station and version).Timezone Offset From UTC(0008,0201)xe "(0008,0201)"3Shall be +0000, to indicate that all DA and TM Attributes present in this SOP Instance are in UTC, and not local time. No other Attributes of this Module shall be present.     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