Drug Evaluation Committee 2007-22 Timing for Submission of Clinical Trial Termination Report
Related classification: clinical trial contracting procedures
Initial release date: Jan. 2008
Revised publication date: Mar 2021
Question
If a subject has already been administered the investigational drug and observed, is it acceptable to submit an End of Study Report even if the CRF and investigational drug have not been collected?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since you said that "the subject's administration of the investigational drug and observation have been completed," we recommend that you first promptly complete the submission of the case report form and return of the unused investigational drug in cooperation with the investigator and sponsor.
In accordance with GCP Article 49, Paragraph 3, the investigator must submit and report a "Report on Termination of Clinical Trial" to the head of the investigational site when the clinical trial is terminated. Although GCP does not stipulate the specific details of the summary to be reported, it is acceptable for the investigator to submit a termination report prior to the submission of the case report, as long as the investigator can include the necessary items stipulated in the termination report of the medical institution in question. However, if the investigator is able to include the required information in the termination report of the medical institution, there should be no problem if the investigator submits the termination report before submitting the case report.
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.