Unanticipated Problems/AE/IND Safety Report Forms
Please submit the forms below to Lou Ashcraft, IRB Administrative Associate I or via fax to 512-697-0086.
IntegReview Safety Reporting Requirements FAQ (revised 10/26/11)
Document utilized for assistance with IntegReview’s Safety Reporting Requirements.
1. Unanticipated Problem/Adverse Device Effect Request Form (revised 02/07/12)
Per federal regulation, IntegReview does NOT require the reporting of AE/SAE reports and IND safety reports, unless they meet the definition of an unanticipated problem.
Unanticipated Problem: Any incident, experience, or outcome that meets all of the following criteria:
(1) Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
(2) Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures in the research); and
(3) Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. Examples of problems or events that may meet the definition of unanticipated problems involving risk to subjects or others may include, but are not limited to the following:
- Imminent threat of a reportable event that has not yet occurred
- Information indicating a change to the risk/benefit ratio of the research
- Death
- Breach of confidentiality, including lost or stolen study documents/data
- IMPORTANT: Do not submit a pregnancy discovered during a research study as an AE. Report a pregnancy as an unanticipated problem (if it meets the definition) or submit as a separate report or accompanied to a Request for Review and Approval Form for IRB review.
- Algorithm for determining AE vs. Unanticipated Problem
2. Request for IND Safety Report(s) Acknowledgement Form (revised 02/01/12)
- If the sponsor or your policies require IND safety reports not meeting the definition of an unanticipated problem to be reported to the IRB, IntegReview will acknowledge receipt of such reports