Drug Evaluation Committee 2014-01 Timing for Submission of Clinical Trial Termination Reports (Part 2)
Related classification: clinical trial contracting procedures
Date of first publication: June 2014
Question
In Clinical Trial 119 Opinion 2007-22, there is a response stating that a termination report can be submitted even before the CRF is collected, as long as all the information that can be included in the termination report is available. I have a similar question. If the CRF and investigational new drug collections have been completed, but only the required archived documents have not yet been confirmed, would it be acceptable to submit the termination report first and confirm the required archived documents after the submission of the termination report?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP does not stipulate the relationship between the timing of the end-of-study report at the site and the timing of the confirmation of archived documents (confirmation of storage status) by the monitor. The clinical trial termination report is a report by the investigator to the head of the medical institution that the clinical trial (medication, observation, etc.) at the medical institution has been completed. Although it is desirable for the monitors at the site to check the preservation status by the time of the investigator's report on the completion of the clinical trial, there is no problem under GCP if it is done after the completion of the clinical trial report. In addition to the previous Opinion 2007-22, please refer to Opinion 2007-16 and Opinion 2009-42.