Drug Evaluation Committee 2010-14 Changes to "List of investigators and collaborators in a clinical trial" prior to the conclusion of a clinical trial agreement
Related classification: investigators, subinvestigators, etc.
Date of first publication: June 2010
Question
Although the clinical trial was approved at the first IRB meeting, the sponsor and the site had to discuss the contents of the contract, and the contract was concluded less than two months after the first IRB meeting.
Since a change in the investigator occurred between the initial IRB and the conclusion of the clinical trial agreement, the "List of investigators and collaborators" was changed and updated once (at that time, the list was issued without any questions). This time, a second change/update request (deletion of CRC) has been received for said list.
Is there any problem with changing or updating the "list of investigators and collaborators" between the first IRB and the conclusion of the clinical trial agreement?
We could not read it from the GCP, so we would appreciate it if you could enlighten us.
JPMA's Opinion
The names and job titles of the collaborators are not included in the clinical trial agreement (GCP Article 13, Paragraph 1). Therefore, there is no problem if the list of investigators and collaborators is updated "by the time the relevant collaborator starts to perform the clinical trial-related tasks assigned by the investigator," rather than "by the time the clinical trial agreement is signed," as you mentioned in your question.