Drug Evaluation Committee 2004-04 Changes in Contracts due to a Change in the Head of a Medical Institution (Part 1)
Related classification: clinical trial contracting procedures
Initial release date: June 2004
Revised release date: December 2021
Question
The director of our hospital was changed in September last year. Since the contracts and other documents for clinical trials before that time were left as they were by the former hospital director, we thought it necessary to change the contracts for ongoing clinical trials, so we asked the sponsor to make changes. The sponsor replied, "There is no need to change anything in particular.
I think that the change of the representative of the medical institution should be addressed in a memorandum of understanding or something. Please let us know your opinion. Also, what about when the title of the principal investigator, etc. is changed?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in Article 13 of the GCP, the contract in question was concluded between your hospital and the sponsor company as a medical institution, and its validity is not lost due to a change in the representative. This is a required entry at the time of conclusion of the contract, and is to be entered as proof that the person in charge of the contract at the hospital has executed the contract. If the name or title of the person in charge of the contract changes, it is not considered necessary to change the contract or to submit a memorandum of understanding.
Reason for revision of opinion
The opinion text has been partially changed in accordance with the issuance of "Handling of Notification of a Clinical Trial Plan for a Drug by a Person Who Wants to Request a Clinical Trial (August 31, 2020, Pharmaceutical Affairs Bureau, No. 0831-10)".