Drug Evaluation Committee 2012-34 Finalization of the Minutes of the Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Initial release date: December 2012
Revised publication date: December 2021
Question
At the investigational new drug review boards (IRBs) that we support, minutes are prepared for each review item after the IRB meeting. The minutes are sent to all committee members in advance of the IRB meeting so that they can confirm the contents. If there are no questions about the minutes sent in advance, the minutes are fixed at the next IRB meeting, and the date of confirmation by the IRB chair is printed on the day following the IRB meeting, with the chair's name and seal affixed as the final version.
Please tell me about the confirmation date. Is it a problem to print the date of confirmation? We recently received an opinion from a sponsor that the confirmation date should be handwritten. We have determined that there is no particular problem even if it is printed since the operation is clearly defined and the IRB members understand this fact. Some sponsors do not have a problem with this, and we have not received any comments on this matter during our on-site inspections.
If this is not a problem, we would like to continue to prepare the protocol in printed form.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In GCP, the basic concept is that the person who signs the document should write the date when signing the document for agreement or declaration of intent, such as when signing the clinical trial protocol (GCP Article 7, Paragraph 4/5, Guidance 4) or the consent document (Article 52). However, GCP does not require the date and signature or name and seal on the record of the Clinical Trial Review Committee meeting (minutes), so it is considered sufficient to prepare and finalize the minutes in the manner prescribed for each Clinical Trial Review Committee. It may look unnatural if only the date of confirmation is printed, but in the case of your question, the process includes confirmation of the minutes by committee members, fixing, printing the specified date of confirmation, printing out the minutes, and signing and sealing the minutes, so that the sealer himself can check the appropriateness of the date when he seals the minutes.
Therefore, we believe that there is no problem as long as the name and seal are affixed within the pre-printed date.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3), the opinion text has been partially changed.