Contact the IRB at (415) 476-1814 or [email protected] and speak with the QIU Analyst of the day with questions. See the Protocol Violation or Incident page for info on reporting for these types of events.

• UCSF reporting requirements apply to all sites relying on the UCSF IRB.
• Studies relying on an external IRB are required to report to the external IRB only.
• For events that involve a privacy related violation, contact Privacy about the incident by emailing [email protected]
• All reporting guidelines apply to research conducted internationally

The IRB of Record will notify the UCSF IRB when a determination of Serious, Continuing, and/or Unanticipated Problem is made.

All applicable UCSF reporting requirements apply to all sites relying on the UCSF IRB.

The Coordinating Center for grants and contracts may or may not be housed at the same institution serving as the IRB of Record. No post-approval reporting to UCSF is required for multi-site studies for which UCSF serves as the coordinating center AND UCSF is not the IRB of Record for the study. Follow the guidance above for reporting to the IRB of Record.

Follow the Reporting Summary Sheet for how to report external events impacting the approved study protocol or Informed Consents.

If an internal (on-site) AE is noted as “unresolved” at the time of initial reporting, a follow-up report is required if the AE does not resolve as expected, or if the AE results in a chronic condition or death.

Follow up reports should also be submitted for “closed,” events if new information becomes available.

Do not include subject names or other direct identifiers on the AE Reporting Form or attachments.

When submitting the Continuing Review Form, complete the sections regarding reportable AEs and other safety information.

Participants must be informed about significant new findings developed during the course of research that may affect willingness to participate. See the Modification page for more details on how to provide this info to current study participants. 

The level of urgency will determine how the information is communicated to participants:

For emergency situations: If participants should be informed immediately, contact participants first and then call the IRB for guidance on how to proceed with a modification and/or follow up for the participants. This option should only be used when there is a certain emergency. For example, the researcher has just received notice that a drug is contaminated and not safe for consumption. The contact of each participant should be documented in the research record. 

All other findings that do not constitute an emergency should be submitted to the IRB for review with the required modification.

For urgent situations: If new findings do not suggest an emergency, but nevertheless require timely changes to the approved research, call the IRB to request urgent review. While significant new findings will generally need to be ultimately reviewed by full committee, a need to inform previous, current or soon-to-be-enrolled participants in a timely manner can often be processed by the IRB on the same day. Document all urgent contact with participants in the research record.

For non-urgent situations: If significant new findings do not require urgent contact with previous, current or soon-to-be-enrolled participants, submit an AE report with the required major modification within the required reporting period of the significant new findings. Participants must receive written notification of clinically important late onset adverse events. The form and content of such notification must receive prior review by the IRB.

Go to My Studies under the IRB Study Assistant. Open the active study for which you want to submit the report.

To determine when and which form to submit, review the guidance above. Click Add New Form to start a blank form. You can copy a previous form by selecting the form you want to copy and clicking Copy Form. The copied form will open automatic.

Anyone listed on the study can sign off and submit it.

• Open the first study again and click on the Adverse Event Reporting Form or Reporting Form link
• Click the "Apply to Multiple" icon next to the correct form
• Check the boxes next to the studies for which you wish to submit this form. Click the "Save a Copy of the Selected Form" button
• You will then need to open each of the studies you selected, open the copied form and submit the form

• AEs that occur in study participants who were enrolled through a UCSF or UCSF affiliated study site
• AEs that occur in a study under the direct supervision of a UCSF PI and for which the IRB of record

• Adverse Events that occur in study participants who are not enrolled at a UCSF or affiliated study site. These AEs occur at sites that are under the oversight of another IRB. 
• The PI typically receives notification of these External Safety Reports (e.g., SUSAR reports) from the study sponsor and these AEs are usually referred to as Sponsor Safety Reports or Safety Memos. 
• When sponsors require IRB review, these reports should be submitted on the iRIS 'Reporting Form.'
• These reports must be submitted when the incident will result in a change of risks. 

An AE that may be reasonably anticipated to occur as a result of the study procedures or study participation and should thus be described in the research proposal, the informed consent document and Investigator’s Brochure (when applicable), or is part of the normal disease process or protocol. 

These types of events may be documented on the internal AE study log. They are not required to be reported on the AE form UNLESS they exceed the nature, severity, or frequency described in the protocol, study consent form, Investigator’s Brochure or other study information previously reviewed and approved by the IRB.

An adverse event is defined as being unexpected if the event exceeds the nature, severity or frequency described in the current IRB Application including the protocol, consent form and investigator brochure (when applicable). An unexpected AE also includes any AE that meets any of the following criteria:

• Results in subject withdrawal from study participation
• Due to an overdose of study medication
• Due to a deviation from the IRB approved study protocol

These types of events must be reported to the IRB using the AE form if they are also serious. 

Any AE that results in any of the following outcomes:

• Death,
• Life-threatening adverse experience**
• Inpatient hospitalization or prolongation of existing hospitalization
• Persistent or significant disability/incapacity
• Congenital anomaly/birth defect, or cancer
• Any other experience that suggests a significant hazard, contraindication, side effect or precaution that may require medical or surgical intervention to prevent one of the outcomes listed above
• Event that changes the risk/benefit ratio of the study

*If the IRB-approved protocol definition of SAE differs from the IRB definition of SAE presented here, the protocol-specific definition should be employed. 

** A life-threatening adverse experience is any AE that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death.

Any prospective, human research study that is designed to answer specific questions about the effects or impact of a particular biomedical or behavioral intervention or are designed to answer specific questions about human physiology.

Various entities — including the UCSF PI, the IRB/HRPP, a UCSF oversight entity such as the Cancer Center or CRS, the study sponsor, the SF VAMC, the FDA, etc. — may place a hold on study accrual or other study activity. A hold is sometimes also called a “suspension” or “pause."

With one exception, any hold that is placed on study accrual or other activity is reportable to the IRB. The one exception occurs when the IRB Application and/or the sponsor’s protocol submitted to the IRB includes a planned hold on accrual/activity.

For instance, the IRB-approved protocol may indicate that after accrual of n subjects, accrual will cease until a safety analysis can be completed, after which accrual may re-start unless a safety issue is discovered. Thus, a planned hold and subsequent resumption of study accrual/activity need not be reported to the IRB as it has already been approved by the IRB. However, if a planned hold yields new safety information or any other unanticipated problem, or necessitates a change to the consent form or IRB Application, then it should be reported to the IRB.

See the VHA Handbook 1058.01 and SF VAMC guidance.

Serious AE (SAE): An SAE is an AE in human research that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect. An AE is also considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.

Unanticipated (Unexpected): The terms “unanticipated” and “unexpected” refer to an event or problem in VA research that is new or greater than previously known in terms of nature, severity, or frequency, given the procedures described in protocol-related documents and the characteristics of the study population.

Related AE or a Related Problem: A “related” AE or a “related” problem in VA research is an AE or problem that may reasonably be regarded as caused by, or probably caused by, the research (see 21 CFR 312.64).

An AE is definitely related to study participation if it is clear that the event was caused by study participation. A definitely related event has a strong temporal relationship and an alternative cause is unlikely.

An AE is probably related when there is a reasonable possibility that the event is likely to have been caused by study participation. The AE has a timely relationship to the study procedure(s) and follows a known pattern of response, but a potential alternative cause may be present.

An AE is possibly related when there is a reasonable possibility that the event might have been caused by study participation. A possibly related event may follow no known pattern of response and an alternative cause seems more likely. In other circumstances there may be significant uncertainty about the cause of the event, or a possible relationship to study participation cannot reasonably be ruled out.

The cause of the AE is known and the event is in no way related to any aspect of study participation. If there is any uncertainty regarding AE causality then the event must be assessed as possibly related to research participation and reported to the IRB as indicated. Often, the cause of an unrelated AE is disease progression.

Do not submit non-reportable study sponsor IND/IDE safety reports to the IRB.

Note: The actual study sponsor safety reports should be kept in your study files unless the AE meets the IRB 10-working-day reporting criteria, in which case the IND or IDE Safety Report should be included with submission of the Adverse Event Reporting Form.

Individual reports of internal (sites for which UCSF is the IRB of Record) AEs determined to be unrelated to research participation should not be reported to the IRB.

Individual reports of internal (sites for which UCSF is the IRB of Record)AEs determined to be related but not serious, unanticipated or more frequent/severe than anticipated should not be reported to the IRB.

Instead, these events should be documented, referenced and retained in the PI’s study files for follow-up. The IRB no longer accepts AE Summary Log reports of AEs that do not meet the IRB reporting criteria.

The following template may be used to document these events.

Acknowledge the report — Acknowledgement letter is issued. To view acknowledged documents, select “All” or filter by “Acknowledged,” after no letters are issued unless they are reviewed at a convened meeting. Please review this quick guide (MyAccess login required) for more guidance.

Request additional information about the adverse event or other safety information.

Refer the AE report (or other safety information) to the IRB if it appears to meet the institutional definition of an Unanticipated Problem (UP) involving risk to participants or others. The IRB may query you for additional information and will inform you if the UP determination is made.

Report the event to OHRP, appropriate University officials, study sponsors and FDA (for studies under FDA oversight) if a full IRB panel review determines that the event report or safety information is an UP.

Flag the report and monitor the study for additional AEs.

Require a modification to the study protocol and/or informed consent document. Note, it is likely that the IRB will require changes to the Informed Consent document or require notification to participants as a result of Adverse events that meet reporting criteria. The IRB recommends, that proposed ICF changes are presented on the AE form or a related Modification form.

Temporarily suspend enrollment and/or study treatment.

Permanently suspend or terminate approval of research that has been associated with unexpected serious harm to participants.

An unexpected, research-related event where the risk exceeds the nature, severity, or frequency described in the protocol, study consent form, Investigator’s Brochure or other study information previously reviewed and approved by the IRB.