Drug Evaluation Committee 2009-41 Change of investigators (Part 4)
Related classification: Principal investigators, subinvestigators, etc.
Date of first release: Feb. 2010
Question
Background
Due to the investigator's poor health, emergency hospitalization and long-term medical treatment (hospitalization for the time being) are required. The site is in the process of implementing procedures for changing the principal investigator. The investigator is still hospitalized, but documents and other information can be confirmed. In addition, a substitute has been appointed by the executing medical institution, and procedures are being carried out in consideration of the safety of the subjects.
Currently, the investigative protocol and other documents are promptly agreed upon, and the new investigator will nominate a collaborator before the IRB.
Question
Who should apply for various changes (change of investigator, change of consent document, clinical trial agreement) due to the change of investigators: the sponsor + current investigator or the sponsor + new investigator? Since there is a change in the consent document, is it not necessary to apply for the new investigator? Also, should we generate a separate form for the consent document only?
Currently, the sponsor is of the opinion that the application by the current investigator is acceptable, but we would like to know if there is any problem with this in terms of GCP.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
A principal investigator is officially appointed after deliberation by the investigational review committee, approval by the head of the medical institution, and conclusion of a contract. In the case of a change of investigator, the new investigator is a candidate and not the principal investigator. Therefore, it is appropriate for the applicant to be the "sponsor + current principal investigator. However, if the current investigator's condition is not good and the application procedure cannot be completed, it is unavoidable to submit the application as "the sponsor + new investigator" after discussion with the sponsor.
In addition, for the revision of the explanatory document, after the change of investigator is approved, the new investigator will be asked to submit a request for review of the revised version prepared by the new investigator. However, if the new investigator has already prepared a revised version, there is no problem in submitting the application together from the viewpoint of continuing the clinical trial.