ࡱ> U .bjbjnn lbaaa_""8lV nb" ./// 1fp2$3\uwwwwww$t*%30" 133//@5@5@53R//u@53u@5@5r@x/p4a3vt8aք0tH4jpxxi|33@53333343333333333333333"B d: Guide for Reporting Unexpected Problems to the IRB Administration Office at WSU Principal investigators must report any of the following to the IRB as soon as possible, but within 5 working days. Refer to the IRB policy on Unexpected Problems at  HYPERLINK "http://www.irb.wayne.edu" www.irb.wayne.edu. Use this form to report the following types of problems: Non-Compliance: The failure to comply with all federal regulations, including Veterans Administration regulations and guidance, state and local requirements, WSU Policy and determinations of the IRB. Adverse Event: Any harm experienced by a participant regardless of whether the event was internal (on-site) or external (off-site) and regardless of whether the event meets the FDA definition of serious adverse event, which in the opinion of the principal investigator are both unexpected and related (definitely, probably or more likely than not). An adverse event is unexpected when its specificity and severity are not accurately reflected in the informed consent document, the protocol, or the investigators brochure. An adverse event is related to the research procedures if in the opinion of the principal investigator it was more likely than not to be caused by the research procedures, or if it is more likely than not that the event affects the rights and welfare of current participants. Refer to Unanticipated Problems Involving Risk and the Adverse Event algorithm. Any harm experienced by a participant or others as a result of involvement in research activities (internal or external excluding adverse events). Information that indicates a change to the risks or potential benefits of the research. For example: An interim analysis or safety monitoring report indicates that frequency or magnitude of harm or benefit may be different than initially presented to the IRB. A paper is published from another study that shows the risks or potential benefits of the research may be different than initially presented to the IRB. Study put on hold by the PI, FDA, or the Sponsor for reasons that may include safety, toxicity and/or efficacy. A change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol. Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research participant. Research conducted without prior WSU IRB approval. Event that requires prompt reporting to the sponsor. Unanticipated adverse device effect: Any serious adverse effect on health or safety, or any life-threatening problem or death caused by, or associated with, a device if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. Sponsor-imposed suspension for risk. Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team. A breach of confidentiality Protocol violation/deviation (meaning an accidental or unintentional change to the IRB-approved protocol) that harmed participants or others, or that indicates participants or others may have been placed at increased risk of harm. For example: Failure to draw safety labs Request for continuation submitted late to the IRB Administration Office three years in a row Wrong informed consent signed or failure to obtain informed consent Incarceration of a participant in a protocol not approved to enroll prisoners. All deaths that have happened at WSU or one of its affiliates within 30 days of the last study intervention, and not related to progressive disease. Any death, if the PI feels that it is significant no matter when it occurs. IRB Administration Office 87 E. Canfield, Second Floor Office HYPERLINK "callto:(313)%20577-1628" (313) 577-1628 Detroit, MI48201  HYPERLINK "http://irb.wayne.edu/index.php" \t "_blank" http://irb.wayne.edu/index.php  Unexpected Problem Report Use this form to report all unexpected problems, non-compliance, and adverse events. Only adverse events which in the opinion of the principal investigator are: 1) unexpected, 2) related and 3) causing risk or harm to participants need to be reported. Follow-up reports are required use the Unexpected Problem Follow-up Form On this form, WSU refers to Wayne State University, Detroit Medical Center, Karmanos Cancer Institute, J. D. Dingell VAMC, and Oakwood Hospital. For example, a WSU study is a study conducted by either Wayne State University, Detroit Medical Center, Karmanos Cancer Institute, J. D. Dingell VAMC, or Oakwood Hospital. *Forward your @wayne.edu e-mail to your @med.wayne.edu, @karmanos.org, etc. e-mail in order to receive important e-mail communications regarding your study if you do not access your @wayne.edu e-mail OR go to Pipeline and enter the e-mail account that you wish to use. Non-WSU employees, please enter your e-mail. An e-mail address is required.. Clinical Trials Studies: Please place this form on top, followed by the Sponsors report, and then then any internal tracking forms/coversheets used. Section A: Administrative Information 1.Name of PI FORMTEXT      Date: FORMTEXT      2. Department FORMTEXT      *E-mail FORMTEXT      Address  FORMTEXT      Telephone FORMTEXT      Pager FORMTEXT      Fax FORMTEXT      3. Form completed by: FORMTEXT      Telephone FORMTEXT      *E-mail FORMTEXT      Name of Faculty Sponsor/ Faculty Supervisor: FORMCHECKBOX  N/A  FORMTEXT      *E-mail FORMTEXT       Section B: Protocol Information IRB #  FORMTEXT      Project Title: FORMTEXT      Funding Source: FORMTEXT      Status of protocol:  FORMCHECKBOX  Open to accrual  FORMCHECKBOX  Closed to accrual/ intervention continues  FORMCHECKBOX  Closed to accrual/ Research-related interventions complete (participants remain in follow-up only)  FORMCHECKBOX  Closed Is this a VA study? FORMCHECKBOX  Yes report to the VA, as well.  FORMCHECKBOX  NoIs this a DoD funded study? FORMCHECKBOX  Yes  FORMCHECKBOX  No Section C: Event Information Select the appropriate UNEXPECTED PROBLEM: If the study or participant has multiple unexpected problems submit separate reports. Refer to the IRB policy on Unexpected Problems at  HYPERLINK "http://www.irb.wayne.edu" www.irb.wayne.edu  FORMCHECKBOX  Adverse event which in the opinion of the principal investigator is unexpected, related and causing risk or harm to participants. NOTE: It does not matter whether the adverse event is serious or non/serious or on-site/off-site. Refer to Unanticipated Problems Involving Risk and the Adverse Event algorithm on website  FORMCHECKBOX  Death that has happened at WSU or one of its affiliates within 30 days of the last study intervention, and not related to progressive disease.  FORMCHECKBOX  Death that PI feels that it is significant, regardless of when it occurred.  FORMCHECKBOX  Protocol violation/deviation (meaning an accidental or unintentional change to the IRB approved protocol) that harmed participants or others, or that indicates participants or others may be at increased risk of harm.  FORMCHECKBOX  Event that requires prompt reporting to the sponsor.  FORMCHECKBOX  Sponsor-imposed suspension for risk.  FORMCHECKBOX  Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team.  FORMCHECKBOX  Information that indicates a change to the risks or potential benefits of the research.  FORMCHECKBOX  A breach of confidentiality.  FORMCHECKBOX  Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.  FORMCHECKBOX  Change to the protocol made without prior IRB review to eliminate an apparent immediate hazard to a research participant.  FORMCHECKBOX  Research conducted without prior WSU IRB approval.  FORMCHECKBOX  Incarceration of a participant in a protocol not approved to enroll prisoners.  FORMCHECKBOX  Unanticipated adverse device effect. Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.  FORMCHECKBOX  Other:  FORMTEXT      Date of Unexpected Problem/Event FORMTEXT      Date the WSU PI became aware of the Unexpected Problem NOTE: must report to the IRB within 5 working days. FORMTEXT       If reported to the IRB late, please explain why:  FORMTEXT      Have similar events occurred in the past?  FORMCHECKBOX  Yes: Describe  FORMTEXT        FORMCHECKBOX  NoParticipant ID:  FORMTEXT      Age:  FORMTEXT      Sponsor AE #: Attach copy of report and deliver to the IRB Office. Include the form, current Informed Consents and all supporting documentation from sponsor and/or PI FORMTEXT       FORMCHECKBOX  N/AAt what site/location did the Unexpected Problem occur? FORMTEXT       Did the Unexpected Problem occur on the PI s study? FORMCHECKBOX  Yes  FORMCHECKBOX  NoIndicate the number of participants enrolled to date in the PI s study: FORMTEXT       Is this a multicenter study? FORMCHECKBOX  Yes  FORMCHECKBOX  No  go directly to Q#17Is the WSU site serving as the Coordinating Center for the study? FORMCHECKBOX  Yes  FORMCHECKBOX  NoHow will information on this Unexpected Problem be shared with other sites? FORMTEXT       FORMCHECKBOX  N/ADescribe the Unexpected Problem, how it caused harm (either actual or potential) AND how the Unexpected Problem meets WSU criteria for reporting.  FORMTEXT       Does the problem involve the participant signing the wrong consent or no consent was obtained?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  go directly to Q#19a. How many participants were involved?  FORMTEXT       b. Describe the differences between the appropriate consent form and the consent form signed by the participant. Also, attach highlighted copies of the consent forms. FORMTEXT      Is this a report of death due to progressive disease?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  go directly to Q#20a. Describe how the death is related to progressive disease and not treatment: FORMTEXT      Reason/diagnosis for study participation:  FORMTEXT      List all investigational drugs, devices, procedures, interventions:  FORMTEXT       FORMCHECKBOX  NAAt the time of the occurrence of the Unexpected Problem, state where the participant was in the protocol process (e.g., visit 6 of a 12 visit study): FORMTEXT      What action was taken at the site of the occurrence with regard to the study intervention, device, and procedure in response to this Unexpected Problem? The PI is encouraged to take all necessary steps to rectify the problem. FORMCHECKBOX  N/A  FORMCHECKBOX  No action taken  FORMCHECKBOX  Dose adjustment or other alteration of the intervention  FORMCHECKBOX  Temporary discontinuation of study drug/device/procedure Stop Date:  FORMTEXT       Restart Date:  FORMTEXT       Reason for restarting:  FORMTEXT        FORMCHECKBOX  Permanent discontinuation of study drug/device/procedure Date:  FORMTEXT        FORMCHECKBOX  Other - describe the specific care provided and steps taken to correct the problem:  FORMTEXT      What action is being taken to prevent reoccurrence of the reported Unexpected Problem? Please describe a detailed Corrective Action Plan.  FORMTEXT       Note: The PI is encouraged to take all necessary steps to prevent the problem from happening again.Describe how this corrective action plan differs from the process already in place at the time of the unexpectedproblem.  FORMTEXT      Describe how you will evaluate the effectiveness of the corrective action plan  FORMTEXT       FORMCHECKBOX  Process Improvement Select all that apply to your process improvement plan:  FORMCHECKBOX  Checklist: Select the checklist(s) you will be using in your process improvement plan. Note: Submit checklist with the UP Report FORMCHECKBOX  Study Visit  FORMCHECKBOX  Inclusion/Exclusion Criteria FORMCHECKBOX  Consent Process FORMCHECKBOX  Consent Version Tracking FORMCHECKBOX  Regulatory Document Tracking FORMCHECKBOX  Other :  FORMTEXT       FORMCHECKBOX Regulatory Document Management Details:  FORMTEXT       FORMCHECKBOX  Key Personnel Management Details:  FORMTEXT       FORMCHECKBOX  Screening/Recruitment/Enrollment/Consent Process Details:  FORMTEXT       FORMCHECKBOX  Investigational Product Management Details:  FORMTEXT       FORMCHECKBOX Compensation Management Details:  FORMTEXT       FORMCHECKBOX Privacy and Confidentiality Details:  FORMTEXT       FORMTEXT       Other: Details:  FORMTEXT       FORMCHECKBOX  Education: Select the group education was offered to, and provide details.  FORMCHECKBOX  Research Staff Education  FORMCHECKBOX  Clinical/Hospital Staff  FORMCHECKBOX  Other Education Details:  FORMTEXT      Date of Education:  FORMTEXT      Education Provided by:  FORMTEXT      Attended by:  FORMTEXT      Topic:  FORMTEXT       FORMCHECKBOX Communication FORMCHECKBOX  Paper/Electronic: Details  FORMTEXT       FORMCHECKBOX  Oncore/Database: Details:  FORMTEXT       FORMCHECKBOX  Other Details  FORMTEXT       FORMCHECKBOX  Other: Details  FORMTEXT      Is the Unexpected Problem being reported currently listed in the informed consent? FORMCHECKBOX  Yes - attach hard copy of highlighted relevant text from the consent form  FORMCHECKBOX  No - attach the current consent  FORMCHECKBOX  N/A As a result of this Unexpected Problem, will any changes be made to the informed consent and/or the protocol? For Clinical Trials Studies: The PI should consider what the Sponsor recommends, but make an independent decision  FORMCHECKBOX  Yes, added to: - Immediately submit a separate amendment  FORMCHECKBOX  Consent documents  FORMCHECKBOX  Protocol  FORMCHECKBOX  Yes, Sponsor felt it did not need to be added, but I, the PI, want it added to:  FORMCHECKBOX  Consent documents  FORMCHECKBOX  Protocol  FORMCHECKBOX  No, justify why this event will not be added to the consent &/or protocol:  FORMTEXT        FORMCHECKBOX  No, Sponsor felt it did not need to be added and I, the PI, agree Comments, if any:  FORMTEXT      How will currently enrolled participants be informed of the Unexpected Problem? FORMCHECKBOX  Re-consent  FORMCHECKBOX  Consent addendum (submit as a full board amendment)  FORMCHECKBOX  Notification (e.g., letter, phone contact, verbal) Attach copy of notification  FORMCHECKBOX  Not informed  Justify why:  FORMTEXT         Declaration: As the principal investigator for this study, my signature below indicates that I have carefully reviewed this PROBLEM REPORT and find the information provided to be complete and accurate. __________________________________________________ ____________________ Signature of Principal Investigator ONLY Date (MUST be the signature of the PI listed on the protocol)Report Status to WSU: Follow-up reports are required use the Unexpected Problem Follow-up Form Please attached all extra requested documents with this submission in order for it to be accepted. IRB USE ONLY Unexpected Problem Reviewer Determination A. Unexpected Problem  FORMCHECKBOX  Problem is unexpected involving risks to participants or others, because it is unforeseen and Indicates that participants or others are at increased risk of harm. Refer to a convened IRB for review and report to regulatory agencies and institutional official.  FORMCHECKBOX  Problem is NOT unexpected involving risks to participants or others, because it is either Expected, or No harm or risk of harm occurred. No action required under unanticipated problems involving risks to participants or others policy.  FORMCHECKBOX  Problem is idiosyncratic Comments:  FORMTEXT       B. Non-Compliance Is the event Non-Compliance (failure to comply with all federal regulations, including Veteran s Administration regulations and guidance, state and local requirements, WSU Policy and determinations of the IRB)?  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FORMCHECKBOX  No  FORMCHECKBOX  Yes - If different than the UP Reviewers determination, explain why the event is Continuing Non-Compliance:  FORMTEXT       Reviewer Recommendation(s):  FORMCHECKBOX  Accept reviewer recommendation(s) as presented  FORMCHECKBOX  Accept reviewer recommendation(s) with modifications  FORMCHECKBOX  Reviewer recommendation(s) not accepted IRB Recommendation(s) or Comment(s)  FORMTEXT       IRB Chair Signature_____________________________________________________ Required Reporting for VA Studies have special requirements see UP policy and Q# 8 for VA status Required Reporting for DoD research: See Q #9 for DoD status. To the extent provided [DoD, section 219.103 of Reference (c)], WSU-IRB will promptly notify the HRPO of the following: All Adverse Events, suspensions, terminations, and serious or continuing noncompliance regarding DoD-supported research involving human participants. HRPO: An individual who is delegated the respZ !"#$)wι|d|Q|Q>$h0h@-CJOJPJQJ^JaJ$h0hCJOJPJQJ^JaJ/j˹h0hCJOJQJU^JaJ'h0h5CJOJPJQJ^JaJ/jUh0hCJOJQJU^JaJ h0hCJOJQJ^JaJ)jh0hCJOJQJU^JaJ$h0h@-CJOJPJQJ^JaJ h0h@-CJOJQJ^JaJh`CJOJQJ^JaJ  <>@BFHJfӽ|h|h|U@/ h0hgCJOJQJ^JaJ)jh0hgCJOJQJU^JaJ$h0hV,CJOJPJQJ^JaJ'h0h35CJOJPJQJ^JaJ'h0hV,5CJOJPJQJ^JaJ$hOdh3CJOJPJQJ^JaJ3jh0hOdOJQJU\^JaJmHnHu*jAh0hOdOJQJU\aJh0hOdOJQJ\aJ$jh0hOdOJQJU\aJhOdOJQJ\aJfhjlzqqaQa<+ h0he`CJOJQJ^JaJ)jh0he`CJOJQJU^JaJh0hgCJOJQJ\aJh0he`CJOJQJ\aJ'h0h35CJOJPJQJ^JaJ'h0he`5CJOJPJQJ^JaJ'h0hV,5CJOJPJQJ^JaJ'h0h=~"5CJOJPJQJ^JaJ h0hgCJOJQJ^JaJ)jh0hgCJOJQJU^JaJ/jh0hgCJOJQJU^JaJ.024Z\^`|~qqYqqIh0he`CJOJQJ\aJ/jh0he`CJOJQJU^JaJ'h0h35CJOJPJQJ^JaJ'h0h+)5CJOJPJQJ^JaJ'h0hV,5CJOJPJQJ^JaJ'h0he`5CJOJPJQJ^JaJ h0he`CJOJQJ^JaJ)jh0he`CJOJQJU^JaJ/j/h0he`CJOJQJU^JaJFH,---------...$ !(a$gd dd[$\$gd* !P'xgd*gdOd ^`gd ^`gdg 468BD۳|bN6/h0h*5>*B* CJOJQJ^JaJphH'h0h5CJOJPJQJ^JaJ3jh0hOdOJQJU\^JaJmHnHu*jh0hOdOJQJU\aJh0hOdOJQJ\aJ$jh0hOdOJQJU\aJ'h0h*5CJOJPJQJ^JaJ'h0hV,5CJOJPJQJ^JaJ'h0h35CJOJPJQJ^JaJ h0hgCJOJQJ^JaJpv$Zi H,,,,|z^@:h0h*56>*B* CJOJQJ^JaJmH phHsH 7h0h*5>*B* CJOJQJ^JaJmH phHsH U/h0h*6>*B* CJOJQJ^JaJphH,h0h*>*B* CJOJQJ^JaJphH#hCB* CJOJQJ^JaJphH/h0h*5>*B* CJOJQJ^JaJphH)h0hwB* CJOJQJ^JaJphH)h0h*B* CJOJQJ^JaJphHonsibilities as defined in paragraph (a)(2) of section 252.235-7004 of Reference (n). There may be more than one HRPO in a DoD Component. Some DoD Components may use a different title for the person(s) with the defined responsibilities. The DoN must be notified of any audits, investigations or inspections of DoN supported research. The IRB will report such inspections to DoN only when the IRB conduct or are aware of the inspection.     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