Drug Evaluation Committee 2013-04 Review by the Clinical Trial Review Committee for additional/changed information on SAEs
Related classification: Report of adverse drug reactions, etc.
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 outcome date (which may be a problem of interpretation of the outcome date).
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.
JPMA's Opinion
Whether or not the IRB needs to review a SAE report (follow-up report) in which the SAE outcome date has been changed depends on whether the head of the site determines that 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 the opinion of the investigational review committee already issued for the SAE in question. The decision depends on whether or not the director of the Investigator Site determines that the new information will affect the "conduct of the clinical trial" as defined in Article 31, Paragraph 2, Guidance 3 of the GCP and the opinions of the Clinical Trial Review Committee regarding the SAE.
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.