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Human research investigators are responsible for reporting any unanticipated problems involving risks to subjects or others associated with an approved IRB study or, in rare cases, with a study that is closed. These reports are most often required for researchers conducting biomedical research. Occasionally, a researcher from the General Campus conducting a higher risk study may also be required to report an adverse event.
See Post-Approval Reporting Requirements for Investigators for additional information.
Use the form below to report any adverse event (AE) that occurs at UCLA, or at an affiliated institution or other site where the UCLA IRB is the responsible IRB.
- Report within 2 WORKING DAYS OF AWARENESS a subject death that is unexpected, related, or possibly related, and occurs in an interventional study. Do not report subject deaths that occur in non-interventional studies (e.g., surveys, interviews, and observational studies).
- Report within 10 WORKING DAYS OF AWARENESS any AE that occurs at UCLA, or at an affiliated institution or other site where the UCLA IRB is the responsible IRB, and is determined by the UCLA PI to be either
- unexpected (see definitions below), related or possibly related to the research activity; and serious, i.e., placing subjects or others at greater risk or harm than previously known or
- expected and related but indicating a higher severity or frequency of occurrence than was known or described in the current approved Informed Consent Form (ICF), and therefore is a new risk.
- Internal (on-site) Adverse Event Reporting Form
- Decision Tree for Reporting Internal Adverse Events
- Decision Tree for Reporting Internal Deaths
Use this form below to report within 10 WORKING DAYS OF AWARENESS any adverse event (AE) that occurs in a study participant who is not enrolled in a study site approved by the UCLA IRB and is determined by the UCLA PI to fit one of the following descriptions:
- Unexpected, related or possibly related to the research activity, and serious, that is, placing subjects or others at greater risk or harm than previously known
- indicates a potential risk that requires notification of previously enrolled subjects and all subjects at the UCLA site who have completed study participation
Do not report the event if the above-listed reporting criteria are not met or
If all subjects at the UCLA site have completed study participation, and the event poses no new risk
- External (off site) Adverse Event Reporting Form
- Decision Tree for Reporting External Adverse Events
The link below provides a summary of all the post approval reporting requirements and can be used as an easy one-page reference.
Post Approval Reporting Summary Sheet
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