Drug Evaluation Committee 2011-12 Procedures for changing the name of a clinical department at a medical institution conducting a clinical trial
Related classification: Principal investigators, subinvestigators, etc.
First published: Aug 2011
Question
The name of the department conducting the clinical trial has been changed from Department of Cardiology to Department of Cardiology. The Clinical Research Office's opinion is that it is possible to use a letter to change the name of the department, but we are having a hard time doing so because there are differences in the opinions of the sponsors. However, we are at a loss as each sponsor has a different view.
Incidentally, when we checked with the sponsor of the current clinical trial, one company responded that we can handle everything including the contract (list of investigators and collaborators, curriculum vitae, consent document, etc.) with a replacement letter, but one company said that we need to submit a change application form (Form 10), change the contract, and update the curriculum vitae.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 28, Paragraph 2, Guidance 2 (7) (ii) of the GCP, a change in the name of a department is treated as a change related to administrative matters. Such changes in administrative matters should be handled in accordance with your hospital's operational procedures.
The change in the name of the department is considered to be a matter that is well known within the site, so there should be no problem in using a replacement letter, etc., as you have asked (please refer to our previous Opinion 2007-33 ).
In addition, when explaining participation in a clinical trial to new subjects, it would be desirable to use an explanatory letter that includes the name of the most recent department as contact information. Therefore, we believe that a review by the Clinical Trial Review Committee is not necessary.