Adverse Reaction (AR) and Unexpected Event (UE) Form



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 irb.wayne.edu. Use this form to report the following types of problems:

▪ Non-Compliance: The 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.

▪ 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).

o An adverse event is “unexpected” when its specificity and severity are not accurately reflected in the informed consent document, the protocol, or the investigator’s brochure.

o 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.

o 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:

o 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.

o 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.

o 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:

o Failure to draw safety labs

o Request for continuation submitted late to the IRB Administration Office three years in a row

o 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 (313) 577-1628

                      Detroit, MI  48201             

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, @, 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 Sponsor’s report, and then then any internal tracking forms/coversheets used.

Section A: Administrative Information

|1. |Name of PI |      |Date: |      |

|2. |Department |      |*E-mail |      |

| |Address |      |Telephone |      |

| | | |Pager |      |

| | | |Fax |      |

|3. |Form completed by: |      |

| |Telephone |      |*E-mail |      |

| |Name of Faculty Sponsor/ Faculty | N/A |*E-mail |      |

| |Supervisor: |      | | |

Section B: Protocol Information

| |IRB # |      |

| |Project Title: |      |

| |Funding Source: |      |

| |Status of protocol: | Open to accrual |

| | |Closed to accrual/ intervention continues |

| | |Closed to accrual/ Research-related interventions complete (participants remain in follow-up only) |

| | |Closed |

| |Is this a VA study? | Yes – report to the VA, as well. |

| | |No |

| |Is this a DoD funded | Yes |

| |study? |No |

Section C: Event Information

| |Select the appropriate | Adverse event which in the opinion of the principal investigator is unexpected, related and causing risk or harm to |

| |UNEXPECTED PROBLEM: |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 |

| |If the study or | |

| |participant has multiple|Death that has happened at WSU or one of its affiliates within 30 days of the last study intervention, and not related to |

| |unexpected problems |progressive disease. |

| |submit separate reports.| |

| | |Death that PI feels that it is significant, regardless of when it occurred. |

| |Refer to the IRB policy | |

| |on Unexpected Problems |Protocol violation/deviation (meaning an accidental or unintentional change to the IRB approved protocol) that harmed |

| |at irb.wayne.edu |participants or others, or that indicates participants or others may be at increased risk of harm. |

| | | |

| | |Event that requires prompt reporting to the sponsor. |

| | | |

| | |Sponsor-imposed suspension for risk. |

| | | |

| | |Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team. |

| | | |

| | |Information that indicates a change to the risks or potential benefits of the research. |

| | | |

| | |A breach of confidentiality. |

| | | |

| | |Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol. |

| | | |

| | |Change to the protocol made without prior IRB review to eliminate an apparent immediate hazard to a research participant. |

| | | |

| | |Research conducted without prior WSU IRB approval. |

| | | |

| | |Incarceration of a participant in a protocol not approved to enroll prisoners. |

| | | |

| | |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. |

| | |Other:       |

| |Date of Unexpected Problem/Event |      |

| |Date the WSU PI became aware of the Unexpected Problem |      |

| |NOTE: must report to the IRB within 5 working days. |If reported to the IRB late, please explain why:       |

| |Have similar events occurred in the past? | Yes: Describe       |

| | |No |

| |Participant ID:       |Age:       |

| |Sponsor AE #: |      | N/A |

| |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 | | |

| |At what site/location did the Unexpected Problem occur? |      |

| |Did the Unexpected Problem occur on the PI’s study? | Yes |

| | |No |

| |Indicate the number of participants enrolled to date in the PI’s study: |      |

| |Is this a multicenter study? | Yes |

| | |No – go directly to Q#17 |

| |Is the WSU site serving as the Coordinating Center for the study? | Yes |

| | |No |

| |How will information on this Unexpected Problem be shared with other |      | N/A |

| |sites? | | |

| |Describe the Unexpected Problem, how it caused harm (either actual or |      |

| |potential) AND how the Unexpected Problem meets WSU criteria for | |

| |reporting. | |

| |Does the problem involve the participant signing the wrong consent or no | Yes |

| |consent was obtained? |No – go directly to Q#19 |

| |a. How many participants were involved? |      |

| |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. | |

| |Is this a report of death due to progressive disease? | Yes |

| | |No – go directly to Q#20 |

| |a. Describe how the death is related to progressive disease and not |      |

| |treatment: | |

| |Reason/diagnosis for study participation: |      |

| |List all investigational drugs, devices, procedures, interventions: |      | NA |

| |At 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): | |

| |What action was taken at| N/A |

| |the site of the |No action taken |

| |occurrence with regard |Dose adjustment or other alteration of the intervention |

| |to the study |Temporary discontinuation of study drug/device/procedure |

| |intervention, device, |Stop Date:       |

| |and procedure in |Restart Date:       |

| |response to this |Reason for restarting:       |

| |Unexpected Problem? The |Permanent discontinuation of study drug/device/procedure |

| |PI is encouraged to take|Date:       |

| |all necessary steps to |Other - describe the specific care provided and steps taken to correct the problem: |

| |rectify the problem. |      |

| |What action is being |Please describe a detailed Corrective Action Plan. |

| |taken to prevent |      |

| |reoccurrence of the | |

| |reported Unexpected |Note: The PI is encouraged to take all necessary steps to prevent the problem from happening again. |

| |Problem? | |

| | |Describe how this corrective action plan differs from the process already in place at the time of the unexpected problem. |

| | |      |

| | |Describe how you will evaluate the effectiveness of the corrective action plan |

| | |      |

| | | Process Improvement | Checklist: |

| | |Select all that apply to your |Select the checklist(s) you will be using in your process improvement plan. |

| | |process improvement plan: |Note: Submit checklist with the UP Report |

| | | | Key Personnel Management |

| | | |Details:       |

| | | | Screening/Recruitment/Enrollment/Consent Process |

| | | |Details:       |

| | | | Investigational Product Management |

| | | |Details:       |

| | | |Compensation Management |

| | | |Details:       |

| | | |Privacy and Confidentiality |

| | | |Details:       |

| | | |      Other: |

| | | |Details:       |

| | | Education: | Research Staff Education |

| | |Select the group education was |Clinical/Hospital Staff |

| | |offered to, and provide details. |Other Education |

| | | |Details:       |

| | | | Oncore/Database: Details:       |

| | | | Other Details       |

| | | Other: Details       |

| |Is the Unexpected | Yes - attach hard copy of highlighted relevant text from the consent form |

| |Problem being reported |No - attach the current consent |

| |currently listed in the |N/A |

| |informed consent? | |

| |As a result of this | |

| |Unexpected Problem, will|Yes, added to: - Immediately submit a separate amendment |

| |any changes be made to |Consent documents Protocol |

| |the informed consent | |

| |and/or the protocol? For|Yes, Sponsor felt it did not need to be added, but I, the PI, want it added to: |

| |Clinical Trials Studies:|Consent documents Protocol |

| |The PI should consider | |

| |what the Sponsor |No, justify why this event will not be added to the consent &/or protocol:       |

| |recommends, but make an | |

| |independent decision |No, Sponsor felt it did not need to be added and I, the PI, agree |

| | | |

| | |Comments, if any:       |

| |How will currently | Re-consent | |

| |enrolled participants be|Consent addendum (submit as a full board amendment) | |

| |informed of the |Notification (e.g., letter, phone contact, verbal) | |

| |Unexpected Problem? |Attach copy of notification | |

| | | | |

| | |Not informed – Justify why:       | |

| | |

| |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 |

| |

|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. |

|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. |

|Problem is idiosyncratic |

|Comments:       |

| |

|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)? |

|No Yes - Explain why the event is Non-Compliance , Note to reviewer - requires full board review: |

| |

|      |

| |

|If the event is Non-Compliance, is the event Serious 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 that involve one or more of the following: harm to research participants; |

|exposing research participants to a significant risk of substantive harm; compromising the privacy and confidentiality of research participants; damage caused to |

|scientific integrity of the research data that has been collected; willful or knowing non-compliance on the part of the investigator; adversely impacting ethical |

|principles)? |

|No Yes - Explain why the event is Serious Non-Compliance: |

| |

|      |

| |

|If the event is Non-Compliance, is the event Continuing Non-Compliance (repeated pattern of non-compliance by an individual investigator or research staff member |

|either on a single protocol or multiple protocols)? |

|No Yes - Explain why the event is Continuing Non-Compliance: |

| |

|      |

| |

|C. Full Board Review |

| |

|Note: All VA study UP’s require a Full Board Review |

| |

|Requires Full Board Review |

|Does not require Full Board Review |

|Unexpected Problem Reviewer Determination - Continued |

| |

|Reviewer Recommendation(s): |

|Select the required action(s) below: |

|Suspension of enrollment of new participants |

|Suspension of research procedures in currently enrolled participants |

|Suspension of the research |

|Termination of the research |

|Notification of participants when such information may relate to current participants’ willingness to continue to take part in the research or there is a risk to |

|the health or safety of the past or current participants |

|Request additional information or clarification from the PI and/or data safety monitoring committee |

|Require changes in the protocol, consent form or other protocol documents |

|Require current participants to be re-consented to protocol with the changes in the informed consent |

|Note the occurrence of the Unexpected Problem, but take no action |

|Accept report as submitted pending amendment with consent form changes |

|Require a change in the continuing review period |

|Require additional monitoring by the IRB |

|Request a for-cause audit of the protocol, if not already done, and/or a follow-up audit |

|Request further inquiry into other protocols utilizing the experimental drug/device/intervention or procedure in question |

|Determine if a detailed plan for safe withdrawal of participants from the research must be developed to protect their rights and welfare of participants |

|Require that this plan be submitted to the IRB for review and approval |

|Require that appropriate federal regulatory agencies, sponsors, and institutional officials be notified of any unexpected adverse reactions or unexpected events |

|involving risks to participants or others according to the IRB’s Reporting Ups, Suspensions and Terminations Policy: |

|VA DoD OHRP FDA Sponsor Other:       |

| |

|No other action required |

|Additional information needed from PI |

|Other:       |

Reviewer’s Signature: ______________________________________________________ Date:_______________________

Printed Name:                                                             

Comments:      

Full Board IRB Determination: IRB meeting date:      

IRB#:_     ___________

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)?

No Yes - If different than the UP Reviewer’s determination, explain why the event is Non-Compliance:

     

If the event is Non-Compliance, is the event Serious 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 that involve one or more of the following: harm to research participants; exposing research participants to a significant risk of substantive harm; compromising the privacy and confidentiality of research participants; damage caused to scientific integrity of the research data that has been collected; willful or knowing non-compliance on the part of the investigator; adversely impacting ethical principles)?

No Yes - If different than the UP Reviewer’s determination, explain why the event is Serious Non-Compliance:

     

If the event is Non-Compliance, is the event Continuing Non-Compliance (repeated pattern of non-compliance through multiple individual findings of non-compliance by an individual investigator or research staff member either on a single protocol or multiple protocols)?

No Yes - If different than the UP Reviewer’s determination, explain why the event is Continuing Non-Compliance:

     

Reviewer Recommendation(s):

Accept reviewer recommendation(s) as presented

Accept reviewer recommendation(s) with modifications

Reviewer recommendation(s) not accepted

IRB Recommendation(s) or Comment(s)

     

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 responsibilities 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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