Drug Evaluation Committee (1) Change of investigators (Part 1)
Related classification: investigators, subinvestigators, etc.
First published: December 2004
Revised publication date: March 2012
Question
This is a question regarding the documentation procedures when a principal investigator changes after the contract ends and no successor exists. In the case of a clinical trial where the contract ends at the end of the fiscal year and the investigator also happens to be transferred to another facility at the same time, the absence of the 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?
JPMA's Opinion
Since there is no investigator who should submit a clinical trial termination report to the head of the Investigator Site, it cannot be said that there is no problem in light of Article 49, Paragraph 3 of the GCP and the regulations of your institution. For this reason, we would like to request that the parties concerned at the Investigator 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 Investigation Termination Report when information on the change is obtained or on a regular basis.
After the investigator submits the study completion report to the head of the Investigator Site, there is no document that must be addressed to or issued by the investigator under GCP, so we believe that documents specific to the Investigator Site may be handled at the discretion of each Investigator Site. (2) After the submission of the clinical trial completion report After the submission of the completion report, the sponsor may inquire about the case report or visit the site for an audit, so please establish a system for the acceptance of such inquiries and the retention of related documents between the investigator and the subinvestigator or collaborator.
Reason for revision
In accordance with the revision of the "Implementation of Standards for Clinical Trials of 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 have changed the explanation in the opinion.