Drug Evaluation Committee 2005-02 Handling of CVs of Clinical Trial Collaborators
Related classification: Principal investigators, subinvestigators, etc.
First published: May 2006
Revised: Mar. 2012
Question
This page is about the submission of resumes of clinical trial collaborators.
In this context, we have recently had a series of requests from foreign pharmaceutical companies for resumes of CRCs, which caused a bit of confusion in the field.
Originally, Japanese GCP states that physicians are responsible for submitting an up-to-date CV to the sponsor to confirm that they meet the requirements for investigators and subinvestigators.
However, I believe that the investigators are only reviewed by the IRB and approved by the Director, and is it really necessary to submit a CV? I wonder.
When I checked the contents of the CV with the sponsor, it seems that there are no particular uniform contents, such as name, age, gender, last education, and work history.
It is personal information, and if necessary, the sponsor will not refuse it, but the sponsor explains that it is "required globally." or "We have been asked to obtain your curriculum vitae from your home country. This is not satisfactory to the field. I don't think this is going to convince the field.
However, when I am consulted or asked such questions by medical institutions, I cannot say without any evidence, "You don't have to submit your resume. I am wondering how I should respond to them.
Will this trend become the mainstream when any clinical trial is commissioned in the future?
How should the implementing medical institution respond?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We do not think it is necessary to submit CRC resumes for the following reasons.
This case has the same meaning as the existence of medical institutions that require the submission of monitors' CVs, and is considered to be based on the SOP of the sponsor, and is not a standardized industry standard or a regulation, instruction, or request by the authorities.
Under GCP, the selection and appointment of CRCs is the responsibility of the investigator, and the sponsor does not have the authority to appoint or select CRCs. In addition, GCP does not state that the sponsor is to obtain CRC resumes (documents or records related to the clinical trial).
On the other hand, the "Guidelines for the Structure and Contents of the Summary Report of Clinical Trials (May 1, 1996, Pharmaceutical Affairs Council of Japan, No. 335)," on which the ICH E3 guidelines are based, requires the name, affiliation, role in the clinical trial, and qualifications of "nurses ... and others ... who observed key or important variables related to efficacy. However, this is only in the case of important observations, and in a multi-center study, general information on qualifications and roles in the study is sufficient, and a CRC's resume is rarely required.
Therefore, there is no need to submit a curriculum vitae for CRCs (Clinical Research Collaborators) under the Japanese GCP. Furthermore, CRC resumes are not required for clinical trials under the FDA's IND.
If a prospective sponsor requests a CRC's resume, the sponsor should request the reason and basis for the request, and if it is still difficult to accept the request, the sponsor may refuse the request after consulting with the principal investigator and others.
Reason for revision of opinion
Due to the revision of the Notice on GCP Site Surveillance, some relevant parts have been deleted.