Drug Evaluation Committee 2004-05 Changes in Contracts due to a Change in the Head of a Medical Institution (Part 2)
Related classification: clinical trial contracting procedures
Date of first publication: June 2004
Question
The director of a medical institution has recently been replaced. So, here is the change contract. The first part of the form says, "Director of XX Hospital (hereinafter referred to as "A") and Director of XX Hospital (hereinafter referred to as "B")". (hereinafter referred to as "A") and (hereinafter referred to as "B") (hereinafter referred to as "the First Party") and (hereinafter referred to as "the Second Party"), dated as of the month of the 21st of this year," should the name of the Director of the hospital at the time of the most recent contract be entered? According to some clients, we are asked to enter the most recent contract.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If that form is used, it would be appropriate to enter the name of the contractor at the time of the date of conclusion of the referenced contract in the first section.
However, according to Article 13 of the GCP, a clinical trial contract is to be concluded with the "executing medical institution," not with the individual contractor of the executing medical institution. Therefore, the contract is valid as it is even if the person in charge of the contract (in the case of your question, the head of the implementing medical institution) is changed, and it is not necessary to change the clinical trial contract.
In light of the above, we recommend that only the name of the medical institution be listed as the first party in the first part of the change agreement. If you have any other similar forms, we recommend that you consider the description of the first part.