Drug Evaluation Committee 2010-16 Necessity of Continuation Review at the End of Clinical Trial
Related classification: Clinical Trial Review Committee
First published: August 2010
Question
We would appreciate it if you could tell us about the necessity of a continuation review for a clinical trial that will soon reach the end of its contract (one year from the end of the contract).
All the investigational drug administration, subject visits, etc. have been completed. The investigator has not yet submitted the termination report, the CRF has not been fixed, SDV, etc., and the termination report will not be submitted for a while longer.
The sponsor is of the opinion that the clinical trial period is from the date of contract signing (clinical trial start date) to the last visit date of the stipulated visits (not including AE and other follow-up visits), and that if the last visit of the stipulated cases at the site concerned does not exceed one year from the date of contract signing (clinical trial start date), no further review is required. However, the medical institution believes that the clinical trial is still ongoing and a continuing review is necessary until the completion of the clinical trial report is submitted.
However, as a medical institution, we believe that the clinical trial is still ongoing and a continuation review is necessary until the completion of the study end report.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As I stated in my opinion in response to Question No. ( 2008-12: Starting date of the timing of the continuing review ), the purpose of the continuing review by the Investigational Review Committee is to review the status of the clinical trial from the perspective of protecting the human rights, safety, and welfare of the subjects. However, if the appropriateness of continuing a clinical trial can be properly reviewed, I do not see any problem with a delay of a few days. Furthermore, the "duration of the clinical trial" in GCP Article 31, Paragraph 1 is interpreted as "the period during which the medication, observation, etc. specified in the clinical trial protocol are administered.
In the case of your question, "all administration of the investigational drug, visits by subjects, etc. have been completed," so I do not think a continuation review as defined in GCP Article 31, Paragraph 1, is necessary. However, the head of the medical institution (clinical trial office) has no choice but to conclude that the clinical trial is still ongoing unless a termination report is submitted. Therefore, it is necessary to obtain the understanding of the monitor, principal investigator, etc. about proceeding with the procedures for fixing the CRF and submitting a termination report as soon as possible.