Drug Evaluation Committee 2014-01 Timing for Submission of Clinical Trial Termination Reports (Part 2)
Related classification: Clinical trial contract 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. This question is similar to the above, but if the collection of CRF and investigational new drug have already been completed and only the confirmation of essential documents has not yet been completed, would it be acceptable to submit the termination report first and confirm the essential documents after the submission of the termination report?
JPMA's Opinion
GCP does not stipulate the relationship between the timing of the Investigator Site's report on the completion of the clinical trial and the timing of the confirmation of stored documents (confirmation of storage status) by the monitor. In the End of Clinical Trial Report, the investigator reports to the head of the Investigator Site that the clinical trial (medication, observation, etc.) at the Investigator Site has ended. Although it would be desirable for the monitors at Investigator Site to check the storage status by the time of the Investigator Site's report on the completion of the clinical trial, there is no problem under GCP if this is done after the report on the completion of the clinical trial. In addition to the previous Opinion 2007-22, please refer to Opinion 2007-16 and Opinion 2009-42.