Drug Evaluation Committee 2005-07 Change of Responsible Clinical Investigators (Part 2)
Related classification: Principal investigators, subinvestigators, etc.
First published: May 2006
Revised: Mar. 2012
Question
I was wondering if the IRB can review in advance the change of investigator at the IRB meeting in March, when the investigator has not yet been assigned, and then the investigator can become a principal investigator at the hospital where the investigator is assigned from April 1, after the investigator is scheduled to retire as of March 31.
My colleagues are divided in their opinions. I personally think it is a no-no, but some are of the opinion that it is possible.
Each of them has their own rationale, but what is the original position?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding the sudden transfer of a clinical investigator, the revised edition of the Q&A Handbook on the New GCP (published by Elsevier Japan K.K.) states the following in 6-A4.
In the case of a transfer of a principal investigator, the IRB should discuss the notification of change of principal investigator and consider it so that there is no period of time when the principal investigator is absent. Since it is not possible to conduct a clinical trial without a principal investigator, if there are continuing patients, we ask that the change of investigator be made promptly so as not to disadvantage the patients."
We believe that the key points of the response are to eliminate the period of investigator's absence and to ensure that it is not to the disadvantage of the subject.
On the other hand, the following procedure is usually assumed for changing the investigator.
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Investigation/evaluation of the selection of a potential investigator by the sponsor
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Agreement on the study protocol between the sponsor and the new investigator candidate
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Notification by the current investigator to the subjects of the change of investigator/confirmation of their willingness to continue the study
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Review/preparation of explanation documents for subjects by the new investigator candidate
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Preparation and submission of a list of collaborating investigators by the new investigator candidate
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Approval of the list of investigator collaborators by the head of the medical institution
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Review of the new investigator by the Investigational Review Committee
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Conclusion of change of contract
Of the above procedures, (1) is difficult to confirm that the requirements of GCP Article 42 are met before the new investigator is assigned (time available at the new location, securing clinical trial staff, securing subjects within the period, etc.), and (5) may be problematic if the medical institution will accept the change.
The way to avoid these problems is to appoint the current investigator as the new principal investigator, but if this is inappropriate for various reasons, it is most important to ensure that the subject is not disadvantaged.
If there are ongoing subjects, it is possible for the new investigator to continue the clinical trial if a meeting with the potential new investigator is held in advance to discuss post-assignment duties and ensure that the requirements for a principal investigator are met, and if the assignment is certain, if regulations within the medical institution are established to allow the above procedures to be carried out in advance. We believe that it is possible for the new principal investigator to continue the clinical trial.
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Clinical Trials for Pharmaceuticals," "Approval of the list of investigator collaborators by the head of the medical institution" was changed to "Approval of the list of investigator collaborators by the head of the medical institution.