Emory University



Office for Clinical Research (OCR) Study Submission FormNEW SUBMISSION: FORMCHECKBOX Y FORMCHECKBOX NAMENDMENT SUBMISSION: FORMCHECKBOX Y FORMCHECKBOX NBUDGET ONLY SUBMISSION: FORMCHECKBOX Y FORMCHECKBOX NRequired Documents and Information FORMCHECKBOX Completed OCR Study Submission Form FORMCHECKBOX Emory IRB number FORMCHECKBOX Final Protocol FORMCHECKBOX Emory Draft Consent Form OR sponsor version & EU checklist FORMCHECKBOX Sponsor Budget – editable version, prefer excel FORMCHECKBOX Draft Clinical Trial Agreement or Award Letter FORMCHECKBOX PI Effort Sheet(s) (For funded submissions) FORMCHECKBOX If amendment, tracked changes or summary of changes of protocol & ICFOther Documents (If available/applicable) FORMCHECKBOX Y FORMCHECKBOX N Draft Budget Prepared by Department FORMCHECKBOX Y FORMCHECKBOX N GCRC/ACTSI Budget/Cost Analysis FORMCHECKBOX Y FORMCHECKBOX N Radiology Checklist with Radiology Fee & Authorized User Fee if Nuclear Medicine FORMCHECKBOX Y FORMCHECKBOX N Investigator Brochure FORMCHECKBOX Y FORMCHECKBOX N IND/IDE Exemption Letter FORMCHECKBOX Y FORMCHECKBOX N Lab Manual FORMCHECKBOX Y FORMCHECKBOX N EHC Device Form FORMCHECKBOX Y FORMCHECKBOX N Grady OGA Financial Clearance Form FORMCHECKBOX Y FORMCHECKBOX N CHOA LOI BudgetPrincipal Investigator and Department InformationName: FORMTEXT ????? Office Phone #: FORMTEXT ????? Cell Phone #: FORMTEXT ????? School: FORMTEXT ????? Dept: FORMTEXT ????? Division/Working Group: FORMTEXT ????? Email: FORMTEXT ????? Clinical Research Coordinator InformationName: FORMTEXT ????? Office Phone #: FORMTEXT ????? Email: FORMTEXT ?????Cell Phone #: FORMTEXT ????? Department/Research Administrator (DA/RA), RAS Information or Regulatory SpecialistName: FORMTEXT ????? Office Phone #: FORMTEXT ?????Email: FORMTEXT ?????Additional Contacts (who need to be copied on emails or sent the PRA and/or budget)Name: FORMTEXT ????? Name: FORMTEXT ?????Email: FORMTEXT ????? Office Phone #: FORMTEXT ?????Email: FORMTEXT ?????Office Phone #: FORMTEXT ?????Study Information Protocol Title: FORMTEXT ?????Short Title/Acronym/Protocol number: FORMTEXT ????? Protocol Version and Date: FORMTEXT ?????IRB#: FORMTEXT ?????EPEX #: FORMTEXT ????? (if applicable)Type of IRB: FORMTEXT ?????CTA Target Enrollment #: FORMTEXT ????? PI Initiated?: FORMCHECKBOX Y FORMCHECKBOX N Registered with ?: Y FORMCHECKBOX N FORMCHECKBOX Unknown FORMCHECKBOX (NCT) #: FORMTEXT ?????Drug or Device Information (Check all that apply)Drug Study?: FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NA IND#: FORMTEXT ????? IND Exempt?: FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NA IND Holder: FORMTEXT ????? Device Study?: FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NA IDE#: FORMTEXT ????? Category: FORMCHECKBOX A FORMCHECKBOX B IDE Exempt: (FDA approved, 510K, PMA, HDE, or Abbrev IDE): FORMTEXT ?????IDE Holder: FORMTEXT ?????CMS Approved: FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NA FORMCHECKBOX PendingEmory Purchasing Notified? FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NA (see form on If device not provided free, is price approved by Emory Healthcare Purchasing? FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NAName of Drug/Device (If more than 5, list on bottom of next page)-List all drugs that will be used in the study (including pre-meds)Emory/EHC to Purchase drug/device?Provided Free by Sponsor? FORMTEXT ????? FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Y FORMCHECKBOX N FORMTEXT ????? FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Y FORMCHECKBOX N FORMTEXT ????? FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Y FORMCHECKBOX N FORMTEXT ????? FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Y FORMCHECKBOX N FORMTEXT ????? FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Y FORMCHECKBOX NFunding Sources (Check all the apply) FORMCHECKBOX Industry FORMCHECKBOX Federal FORMCHECKBOX Sub-Contract FORMCHECKBOX Foundation FORMCHECKBOX Internal FORMCHECKBOX Unfunded FORMCHECKBOX Other (Specify): FORMTEXT ?????Has the budget been pre-negotiated?: FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NAReceived the Notice of Award?: FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NA Sponsor InformationSponsor Name: FORMTEXT ?????Budget Contact: FORMTEXT ????? Contract Contact: FORMTEXT ????? Email: FORMTEXT ????? Email: FORMTEXT ?????Phone #: FORMTEXT ????? Phone #: FORMTEXT ?????Contract Research Organization (CRO) FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX NACRO Name: FORMTEXT ?????Budget Contact: FORMTEXT ????? Contract Contact: FORMTEXT ?????Email: FORMTEXT ????? Email: FORMTEXT ?????Phone #: FORMTEXT ????? Phone #: FORMTEXT ?????Check all Facilities where Subjects will be seen FORMCHECKBOX Emory Clinic (TEC) FORMCHECKBOX Emory University Hospital (EUH) FORMCHECKBOX Emory University Hospital Midtown (EUHM) FORMCHECKBOX Emory John’s Creek Hospital FORMCHECKBOX Emory Saint Joseph’s Hospital FORMCHECKBOX Emory Decatur Hospital FORMCHECKBOX Emory Hillandale Hospital FORMCHECKBOX Emory LTAC FORMCHECKBOX Emory Wesley Woods Hospital FORMCHECKBOX Emory Vaccine Center (Hope Clinic) FORMCHECKBOX Emory Children’s Center (ECC) FORMCHECKBOX Emory Orthopedic & Spine Hospital FORMCHECKBOX Grady Health System FORMCHECKBOX Grady-Ponce Center FORMCHECKBOX Children’s Egleston FORMCHECKBOX Hughes Spalding FORMCHECKBOX Scottish Rite FORMCHECKBOX Other (Specify): FORMTEXT ?????Protocol Required Study Items/Services – Regardless if SOC/Routine Care – Check all that applyPhysical Exam/Office Visit FORMCHECKBOX Y FORMCHECKBOX N Research Room - no EHC billable FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX CPT code used FORMCHECKBOX No CPT code used (Effort only) *Approved by Dept Administrator? FORMCHECKBOX Y FORMCHECKBOX N Use of Ancillary Department Services? FORMCHECKBOX Y FORMCHECKBOX N Has ancillary department approved participation in study? FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Ophthalmology FORMCHECKBOX Dermatology FORMCHECKBOX EPIC – Emory Personalized Immunotherapy Core FORMCHECKBOX Cellular Therapy Lab FORMCHECKBOX Cardiology FORMCHECKBOX List other services: FORMTEXT ?????Electrocardiogram (ECG) FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Sponsor provided ECG machine FORMCHECKBOX Study Staff will perform FORMCHECKBOX Cardiology will perform FORMCHECKBOX Cardiology will read FORMCHECKBOX Study staff will read FORMCHECKBOX Tracing to Central LabPregnancy Test FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Test sent to Emory Lab FORMCHECKBOX Test sent to Grady Lab FORMCHECKBOX Test sent to Central Lab FORMCHECKBOX Kits provided by sponsor FORMCHECKBOX Kits bought by department FORMCHECKBOX POC (Point of Care Testing)Radiology/Imaging FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Emory Radiology FORMCHECKBOX CSI/WW FORMCHECKBOX FERN FORMCHECKBOX Sibley Heart Center FORMCHECKBOX Grady FORMCHECKBOX CHOA FORMCHECKBOX BITC FORMCHECKBOX Other (Specify): FORMTEXT ?????Laboratory Testing FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Emory Medical Lab (EML) FORMCHECKBOX Emory Pathology Lab FORMCHECKBOX Central Lab FORMCHECKBOX Emory Research Lab FORMCHECKBOX Grady Laboratory FORMCHECKBOX Emory Genetics Laboratory FORMCHECKBOX Other (Specify): FORMTEXT ????? FORMCHECKBOX POC (Specify): FORMTEXT ????? FORMCHECKBOX Additional lab preparatory fees, provide cost: FORMTEXT ????? Hospital Services FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Overnight stay FORMCHECKBOX PACU FORMCHECKBOX Operating Room FORMCHECKBOX Other: FORMTEXT ?????Anesthesia/Sedation FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX General Anesthesia FORMCHECKBOX Conscious/MAC Sedation FORMCHECKBOX LocalTime required (min): FORMTEXT ?????Infusion Center FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Winship Phase I unit FORMCHECKBOX Winship Plaza Level FORMCHECKBOX Executive Park FORMCHECKBOX Other: FORMTEXT ????? FORMCHECKBOX TEC-6B FORMCHECKBOX TEC-3A FORMCHECKBOX GCRCAmbulatory Surgery Center FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Executive Park FORMCHECKBOX EUHM FORMCHECKBOX TEC-Building B-Tunnel FORMCHECKBOX Other: FORMTEXT ?????GCRC FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX Overnight stay FORMCHECKBOX Infusions FORMCHECKBOX Pediatric Research Center FORMCHECKBOX Other: FORMTEXT ?????Other CORE facilities FORMCHECKBOX Y FORMCHECKBOX N FORMCHECKBOX BITC FORMCHECKBOX FERN FORMCHECKBOX CSI FORMCHECKBOX Other: FORMTEXT ?????Patient Compensation/Lodging or Transportation? FORMCHECKBOX Y FORMCHECKBOX N Amount(s): FORMTEXT ?????Comments – Additional Information or Items/Services Not Addressed Above FORMTEXT ?????Signature of person completing the form with date:Signature: FORMTEXT ?????Date: FORMTEXT ????? ................
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