Drug Evaluation Committee 2009-42 Direct Inspection after a Clinical Trial Completion Report
Related classification: Clinical trial contract procedures
First published: Feb 2010
Question
We would like to ask you how to respond to a request from a sponsor's monitor for direct inspection after the completion of a clinical trial report.
According to publications on clinical trials, "After the Investigator Site has accepted the study completion report, direct inspection by monitors is not allowed. After that, we need to re-sign the agreement." The GCP also states that "the investigational new trial must be conducted by the investigational new trial sponsor.
On the other hand, some sponsors take the view that "if the original contract stipulates that direct inspection can be conducted to the extent necessary to fix the CRF even after the issuance of the study completion report, direct inspection can be conducted without re-signing the contract. The opinion of the investigator and the sponsor may be expressed as follows.
If the investigator and the sponsor confer to confirm that the fixing of the CRF, etc. has been completed and there is no longer a need for direct inspection, and then prepare a report on the completion of the clinical trial, I think this could be avoided. I would like to know the relationship between the issuance of an end-of-study report and direct inspection by monitors.
JPMA's Opinion
GCP does not stipulate the relationship between the timing of the completion of a clinical trial at Investigator Site and direct inspection by monitors. Although it is desirable for the direct inspection by monitors to be completed by the time of the investigator's report on the completion of the clinical trial, there is no problem even if it is conducted after the report on the completion of the clinical trial (see past Opinions 2007-16 and 2007-22 ). If a termination report is not submitted even though the clinical trial (medication, observation, etc.) has essentially ended, because of the possibility of direct inspection, the clinical trial procedural work, such as deliberation of safety information by the Clinical Trial Review Committee, will also continue.