There are no Toolkit checklists for reportable events (REs).  REs that are scheduled for convened board review require a short staff review done via the Staff Summary activity in ARROW to facilitate committee review of the submission. The Staff Summary is done prior to scheduling.

HRP-024 and HRP-052 include process details. 

HRP-321 should be used as a reference during review of REs. 

There are three review pathways for reportable events: 

• IRB analyst sign off
  • The IRB analyst can acknowledge the event using the “Acknowledge Reportable Event” activity form.  A short description as to why no additional action is necessary should be entered textbox 1.1 in the activity form.  The remaining text boxes are typically left blank
• Chair/designee sign off
  • The IRB analyst forwards the event to the chair or designee using the “Send to IRB Member” activity.  Within this activity form, the analyst should enter a short analysis of the event in the comment box:
    • New Information example:  New Information Report regarding IDB update and forthcoming associated change of protocol. Study team has confirmed new risk information will be verbally conveyed (and documented in research record) in the meantime and will submit updated IDB along with revised study documents as a change of protocol when the amendment becomes available. Suggest no further action required.
    • Noncompliance example: The only substantive difference in the consents is the timing of the second sample collection (either leftover from clinical blood or additional research blood drawn during SOC blood draw). Given this and the fact that this was self-discovered, recommend that this does not appear to be serious or continuing noncompliance and no additional actions are necessary. If there are future consenting issues discovered suggest full committee review is possible.
  • After the IRB member reviews and completes the activity form, the RE will come back to the IRB analyst.  If the member agrees with the staff reviewer’s recommendation and raises no new concerns, the analyst can acknowledge the RE using the “Acknowledge Reportable Event” activity form.  See below for template language that should be entered in textbox 1.1.
• Convened board review
  • As noted above, there are no Toolkit checklists for REs. To facilitate member review, analysts should complete the Staff Summary activity in ARROW prior to scheduling.

1. RE's that do not meet the definition of an unanticipated problem, noncompliance, or adverse event (apparent without the need for medical expertise).
   1. Action: IRB Review Not Required
2. Noncompliance reports involving:
   1. Administrative errors that do not impact subjects AND are not serious or continuing as defined by campus or VA policy.  Failure to obtain written consent or authorization is not considered an administrative errors.  Examples include:
      1. Use of an incorrect consent or HIPAA form (outdated or expired) that is accurate with the exception of administrative updates (e.g. study personnel have been updated, minor editorial changes have been made, etc.)
   2. Action: Acknowledge Report
3. New Information Reports involving:
   1. Administrative updates that do not impact local subjects and do not require changes to study documents.  Examples include:
      1. Administrative Sponsor Updates (sponsor name changes, merging, etc.).
      2. CAEPR updates for studies that have not yet been opened to enrollment, have no local subjects enrolled, or have no local subject on the study drug to which the CAEPR pertains AND for which a change of protocol will be submitted prior to opening or recommencing enrollment.
      3. Temporary drug shortages which will have no impact on the UW, either because there is no UW shortage, or there are no local subjects on the affected drug.
   2. Action: Acknowledge Report 

1. Any RE involving a VA subject will be reviewed by the chair or other specially designated member of the IRB to review VA reportable events; if the event appears to represent an unanticipated problem involving risks to subjects or others or serious and/or continuing noncompliance as defined by VA policy, the event will be referred for full IRB review after initial assessment by the IRB Chair (or designee).
2. Unanticipated problem or new information reports for which the study team has voluntarily suspended enrollment and no additional immediate action is likely to be required to protect subjects (e.g. suspending study treatment).
3. Reports describing new safety information that do not appear to represent events that are a) unexpected, immediately life threatening or severely debilitating to subjects; b) caused or probably related to the study treatment/intervention; and c) do represent new information that should be conveyed to participants when the study team has provided with the report a plan to orally inform study participants and update relevant study documents (e.g. submitting a change of protocol to update consent for to include new information).
4. Noncompliance reports that do not fall into either of the other two categories (not administrative, but not likely to be serious or continuing).  Further action may or may not be needed in order to resolve the event.
   1. Noncompliance reports that require medical expertise should be reviewed by the IRB Chair. Examples include:
      1. Missed vital signs
      2. Dosing errors that did not result in risk to the subject
      3. Failure to conduct screening procedures prior to medical imaging
      4. Laboratory tests performed outside of study-specified window 

1. Noncompliance that may be serious or continuing as defined by campus or VA policy.
2. Any RE resulting in action that may be considered precedent setting or that, in the opinion of the IRBD, needs the backing of the Board.
3. Any RE that may require reporting either internally (i.e. the IO), or externally (e.g. FDA, OHRP).

Occasionally, a reportable event unrelated to a study in ARROW needs to be submitted.  This typically occurs when research activities have taken place without IRB approval, so there is no ARROW application under which to submit a reportable event.  In these cases, studies teams should complete HRP-214 and email it to IRBDirector@hsirb.wisc.edu. 

For REs that go to the full committee, the RE should be listed under “Other” on the IRB meeting agenda.  Completed HRP-214 and other documents relevant to the reportable event (e.g., email exchanges, supplemental documents) should be shared with IRB members by creating a Box folder and sharing the link with IRB members.  Under “Link Settings” in Box, click “Require Password” and enter a password.  The password should be shared with IRB members only on the meeting agenda (i.e., not through email) in Arrow along with the RE under “Other.”

HRP-052 and HRP-024 outline the review and processing of reportable events.  When a determination of serious and/or continuing noncompliance or an unanticipated problem has been made (and finalized in the case of noncompliance), the IRB analyst is responsible for drafting the report letter using the template document.  Generally, draft report letters should be reviewed by the following people prior to forwarding to the Institutional Official: 

•     IRB Director or Assistant Director 
•     IRB Chair or vice-chair of the panel who made the determination 
•     Legal counsel present at the meeting at which the determination was made 

The IRB analyst should update the internal tracking sheet in Box with all preliminary, final, and reversed determinations.  

If a Reportable Event is submitted on a study that involves interaction or intervention with prisoners, the prisoner representative should be assigned as the IRB member reviewer.  If the RE requires convened board review, the prisoner representative should be assigned as the primary reviewer.   

See HRP-024 for reports involving enrollment of a prisoner on a study or a subject who becomes a prisoner while enrolled on a study that was not previously approved to enroll this subject population.

Reliance agreements, including the SMART IRB agreement, require that the reviewing IRB notify relevant relying sites of findings of serious and/or continuing noncompliance or a determination that an unanticipated problem has occurred. 

1. For studies where a UW HS or MRR IRB serves as the Reviewing IRB for external site(s) and makes a finding of serious and/or continuing noncompliance or a determination that an unanticipated problem occurred for an external site the following process will be followed [NOTE: Notice of preliminary findings should be sent to irbreliance@wisc.edu. Reliance Team Member may reach out to involved relying site as a courtesy.]
2. If a finding requires reporting to OHRP, FDA, or other external agencies (e.g., federal funding agency such as DoD): 
   1. The RE staff analyst will draft a report letter on behalf of the UW Institutional Official (IO) and obtain internal review as outlined above.
   2. Analyst will then send the UW HS IRB’s finalized draft letter to the Reliant Team. Reliant be responsible for sending the draft letter to the relevant points of contact (POC) at any institutions affected by the determination or finding (i.e. relevant relying site(s)). 
      1. Relying institutions will have 5 business days to provide feedback on the draft letter.
   3. Reliant will collate the feedback received from the POC(s) and email this to the REPP and RE Team Lead. The RE Team Lead and REPP will work together to determine what edits, if any, are needed to the letter. 
      1. The RE staff analyst will send the final draft to the IO. The UW IO is responsible for reporting to OHRP, the FDA, and any other external agencies. The RE staff analyst will copy Reliant on the email to the IO.
         1. The RE Analyst will forward the finalized letter to Reliant, who will email the finalized letter to the Overall PI and relevant relying institution PI and POCs (i.e. the institution at which the reportable event occurred) for notification.
3. If a finding DOES NOT require reporting to OHRP, FDA, or other external agencies: 
   1. The RE Analyst will draft a report letter on behalf of the IRB Chair (or designee) and obtain internal review of the letter as outlined above.
   2. The RE Analyst will forward the finalized letter to Reliant, who will email the finalized letter to the Overall PI and relevant relying institution PI and POCs (i.e. the institution at which the reportable event occurred) for notification.
      1. For findings that occur at UW see the above section regarding reporting requirements for serious/continuing noncompliance/unanticipated problems occurring at UW.
4. For findings of serious and/or continuing noncompliance or a determination that an unanticipated problem that occurred at UW on a study for which UW has ceded IRB review to an external site, the following process will be followed: 
   1. The reviewing IRB will notify Reliant of the finding and will provide a draft report letter (for non-federally funded studies, there may only be a notice of reporting to the FDA when applicable, and/or a letter stating that reporting to OHRP is optional due to funding source and up to UW) . The RTM will forward the draft letter to the REPP for review. 
      1. In the event the first notification of the event to UW-Madison is via reportable event submission in ARROW from the UW study team, Reliant will reach out to the reviewing IRB to obtain a draft of the report letter and consult on next steps in the reviewing IRB’s review process. 
   2. The RE Analyst will review and suggest edits to the draft letter. The RE Analyst may suggest the RTM consult with the IO in cases of extensive letter edits.
   3. The RE Analyst will review the corrective action plan and may suggest additional corrective actions.  If the event or proposed corrective actions raise concern, the Analyst will consult with the IRB Director and Chair to determine if additional local actions are necessary.
   4. Any edits will be forwarded to Reliant within the 5-day timeframe. Reliant will forward the suggested edits to the reviewing IRB contact person. The Reviewing IRB may or may not incorporate any suggested edits.
   5. Once received, Reliant will forward the finalized report letter to OVCRGE at compliance@research.wisc.edu for documentation purposes AND upload a copy to the ceded application in ARROW (in the RE workspace for studies able to submit).  The RTM may request the UW study team submit a RE to the cede application in ARROW for documentation if one is not submitted already.
   6. The UW is not responsible for any further reporting, unless RTM indicates otherwise as required by a specific reliance agreement.