Drug Evaluation Committee (1) Change of Responsible Clinical Investigators (Part 1)
Related classification: Principal investigators, subinvestigators, etc.
First published: December 2004
Revised publication date: March 2012
Question
This is a question regarding the documentation procedures when a clinical investigator changes after the contract ends and there is no successor. In the case of a clinical trial where the contract ends at the end of the fiscal year and the principal investigator also happens to be transferred to another facility at the same time, the absence of the principal investigator will cause inconvenience in the documents generated from April onward.
If the contract is continued, there is no problem because the successor investigator takes over the contract, but in the above case, there is no investigator at all.
For example, at our hospital, after the new GCP is enforced, the chief of the department and the principal investigator are supposed to submit a report on the completion of the clinical trial to the hospital director (jointly named in the form) at the end of the clinical trial.
In such a case, is there any problem under GCP even if only the signature and seal of the department head is required?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since there is no investigator who is supposed to submit the completion report to the head of the site, this would not be a problem in light of Article 49, Paragraph 3 of GCP and the regulations of your facility. For this reason, we would like to request that the parties concerned at the site, for example, take the following points into consideration in order to avoid the above situation.
Principal investigator
(1) If the clinical trial is expected to be completed by the date of transfer, a completion report should be submitted immediately after the completion of the clinical trial. (2) If the clinical trial is not expected to be completed by the date of transfer, the procedures for changing the investigator will be promptly implemented.
Secretariat, etc.
(3) The investigator will be informed of the necessity of submitting an Investigational Trial Termination Report when information on the change is obtained or on a regular basis.
After the investigator submits the study termination report to the head of the site, there is no document that must be addressed to or issued by the investigator under GCP, so we believe that site-specific documents can be handled at the discretion of each site. (2) After the submission of the clinical trial completion report After the submission of the clinical trial completion report, the sponsor may make inquiries related to the case report form or visit the site for an audit, so we ask that a system be established for the acceptance of such inquiries and the retention of related documents between the investigator and the subinvestigator or collaborator.
Reason for revision of opinion
In accordance with the revision of the "Implementation of Standards for Clinical Trials for Pharmaceuticals" (October 24, 2011), we have reviewed the necessity of the investigator's name and seal or signature on the clinical trial completion report, and changed the explanation in the opinion.