Drug Evaluation Committee 2009-42 Direct Access after the End of Clinical Trial Report
Related classification: clinical trial contracting procedures
Date of first release: Feb. 2010
Question
We would like to ask you what to do when a sponsor's monitor requests direct access to a clinical trial after the completion of a clinical trial report.
According to publications on clinical trials, "After the investigational site accepts the study termination report, it is not possible to accept direct inspection by the monitor. After that, we need to re-sign the agreement." There is also the view that "the sponsor must submit a new application as an additional investigation (re-investigation), which must be reviewed and approved by the IRB, and then a new agreement must be signed.
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. is completed and there is no longer a need for direct inspection, and then the investigator prepares a report on the completion of the clinical trial, this may be avoided. I would like to know the relationship between the issuance of an end-of-study report and direct inspection by monitors.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP does not stipulate the relationship between the timing of the end of a clinical trial at the site and direct inspection by monitors. Although it is desirable that the direct inspection by the monitor be completed by the time of the investigator's report of the termination of the clinical trial, there is no problem even if it is conducted after the report of the termination 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.