Drug Evaluation Committee 2013-04 Review by the Clinical Trial Review Committee for additional/changed information on SAEs
Related classification: Adverse drug reaction reports
First published: May 2013
Question
Due to a serious adverse event (SAE) that occurred at our hospital, a report on the SAE was prepared and reviewed by the investigational review board (IRB) after SDV was conducted by a monitor. At a later date, the sponsor changed its opinion and requested a follow-up SAE report with a different outcome date. There is no change in the SAE outcome itself, and there is no other additional or changed information, only the change in the date of the SAE (which may be a problem of interpretation of the date of the SAE).
In this case, is it necessary for the IRB to review the SAE report (follow-up report) with the changed SAE transposition date? Is it OK to report it on the IRB as a minor change (change in outcome date)? Our SOP does not contain such a detailed provision.
Pharmaceutical Cooperative Opinion
The decision on whether or not a SAE report (follow-up report) with a changed SAE outcome date needs to be reviewed by the IRB depends on whether the new information presented in the follow-up report "affects the conduct of the clinical trial" as defined in GCP Article 31, Section 2, Guidance 3, or affects the opinion of the investigational review committee already issued for the SAE in question. It depends on whether or not the head of the site determines that the SAE will have an impact on the conduct of the clinical trial as defined in Article 31, Paragraph 2, Guidance 3 of GCP.
Even if there is no definition in your hospital's SOP, it is acceptable to make an appropriate judgment in light of the purpose of the guidance.
Please refer to the past Opinions 2009-12, etc. for the position of "report" in the SOP.