Drug Evaluation Committee 2007-16 Recall of Case Report Forms and Investigational New Drugs after expiration of the contract period
Related classification: clinical trial contracting procedures
Initial release date: Jan. 2008
Revised publication date: Mar 2021
Question
I had a clinical trial with a contract date of December last year and a contract end date of October 31, 2007,
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Is there a problem if the collection of CRFs and investigational products is not completed within the contract period?
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Is it a problem that the CRF is not fixed and, likewise, the termination report cannot be submitted within the contract period (because the efficacy and safety are not FIXed)?
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We received a request from the sponsor to continue the discussion at the IRB meeting in November 2007.
Can you please tell me what is the best way to do this?
I think we can extend the contract period, but the client's view seems to be that the contract = subject handling.
Incidentally, the protocol of the clinical trial stipulates that the trial period shall be the last day of the hospital visit as stipulated in the protocol.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 13, Paragraph 1, Item 7 of the GCP stipulates "the duration of the clinical trial" as a matter to be described in the clinical trial agreement. It is important for the sponsor and the investigational site to have a common understanding of the interpretation of the clinical trial period in the clinical trial agreement. Normally, the clinical trial period is interpreted as the period during which the administration and observation specified in the protocol are completed, and is considered to be the same as the clinical trial period described in the clinical trial agreement.
In this case, it is desirable to collect the CRF and unused study drug within the trial period, but depending on the timing of the last subject's participation, there may be cases where the collection of these items exceeds the trial period stated in the agreement. In addition, the termination report prepared by the investigator and the termination notice from the head of the site would also have to be handled after the trial period for cases like the above. As for the continuation procedures after the trial period, I assume that the sponsor is requesting a continuation review of the collected adverse drug reaction information because the investigators have not submitted a termination report. In this case, too, there is no problem with the information being reviewed after the clinical trial period, but if the administration of the investigational drug and observation have already been completed, there is no need for the investigator to review the safety information at the investigator review committee. However, it is important to have the investigator submit a termination report as soon as possible after the completion of the clinical trial.
Reason for revision of opinion
In accordance with the revision of the GCP Ministerial Ordinance (Ministry of Health, Labor and Welfare Ordinance No. 155, August 31, 2020) and the revision of the GCP Guidance (Pharmaceutical Affairs Council Announcement No. 0831-15, August 31, 2020), we have changed some of the questions and statements of opinion.