Drug Evaluation Committee 2009-41 Change of investigators (Part 4)
Related classification: investigators, subinvestigators, etc.
First published: 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. Investigator Site is in the process of replacing the principal investigator. The investigator is hospitalized, but documents and other information can be confirmed. The Investigator Site has appointed a substitute, and the procedure is being carried out in consideration of the safety of the subject.
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 Explanation 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.
JPMA's Opinion
The investigator is officially appointed after deliberation by the Clinical Trial Review Committee, approval by the Chairperson of the Investigator Site, and conclusion of the contract. In the case of a change of principal investigator, the new principal investigator is a candidate and not a 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 enough to proceed with the application, it is unavoidable to submit the application as "the sponsor + new investigator" after consultation 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.