Drug Evaluation Committee 2005-13 Handling of SAE Reporting for Scheduled Surgical Admissions
Related classification: Adverse drug reaction reports
Initial release date: March 2007
Revised publication date: December 2021
Question
SAE reporting is described in the GCP and each protocol, and we routinely handle SAE reporting in accordance with the content of the protocol.
This time, a patient scheduled for OP at another hospital was reported during a routine visit. This disease had been pointed out to us before the start of the clinical trial, and we were told that we would perform OP when the time was right.
The disease itself was not serious, but a hernia, and since the duration of the clinical trial was long, the patient was OP during the trial period. In our judgment, SAE should be reported at the time of hospitalization for OP, and we did not report SAE at the time we received the report. When we happened to have an opportunity to provide information to the sponsor and reported it to them, they pointed out that we did not report it within 24 hours after we learned of it, and we are now struggling with how to handle the situation.
First of all,
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(1)The fact that the above has not been recognized until now.
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(2)The same scheduled OPs have also been asked to report SAEs at the time of hospitalization, and only the sponsor has a difference of opinion.
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(3)Is it necessary to report several months in advance when a pediatric patient is scheduled for an operation for tonsils or plastic surgery scarring during the summer vacation?
We have decided to hold a meeting to discuss how we should provide guidance to the hospital and ask them to consult with Clinical Trial 119.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to the annex of the "Revision of Q&A for Post-Marketing Adverse Reaction Reports and Adverse Reaction Reports for Clinical Trials in Response to the E2B (R3) Implementation Guide" issued by the Drug Evaluation and Administration Division and the Drug Safety Division of the Pharmaceuticals and Life Health Bureau, Ministry of Health, Labour and Welfare,
2. what to report
Q10: Clinical trial
"Can hospital admissions for the sole purpose of performing pre-trial planned therapies or tests during a clinical trial (e.g., planned surgeries or tests) be excluded from the scope of reporting?
A10: Clinical trial
The answer is "Yes, they may be excluded."
Therefore, hospitalization for previously scheduled surgery is not considered a serious adverse event to be urgently reported in accordance with Article 48, Paragraph 2 of the GCP.
However, there are cases in which the clinical trial protocol defines the scope of reportable events more broadly, and the sponsor needs to collect information as promptly as possible in order to determine whether the event should be reported urgently (e.g., whether it was caused by deterioration during the clinical trial). Therefore, if there is a situation like the one in question, it is necessary to provide the information to the sponsor and both parties should agree on how to handle the information.
Reason for revision of opinion
The administrative communication to which we refer has been changed in accordance with the revision of the "Q&A on Post-Marketing Adverse Reaction Reports and Clinical Trial Adverse Reaction Reports in Response to the E2B (R3) Implementation Guide".