Drug Evaluation Committee 2012-45 Revision and re-consent of the explanatory document coinciding with the change of investigators
Related classification: Obtaining consent
First published: March 2013
Question
Due to the timing of the change of investigators and the provision of the revised investigational new drug summary, we request the current investigators (hereafter referred to as "old investigators") to revise the explanatory documents for subjects and the physicians who will become investigators (hereafter referred to as "new investigators") to prepare the explanatory documents.
Is it acceptable to prepare the same version of the revised explanatory document after consulting with each of the new and old investigators? Or should the new and old investigators each prepare separate revised versions of the explanatory document, and both should be approved by the Investigational Review Committee?
I believe that the change of investigator, the review by the Investigational Review Committee for the revised investigator summary and the revised explanatory document will be conducted at the same time, and a notice of direction and decision by the head of the site will be issued promptly, but the conclusion of the memorandum regarding the change of investigator is likely to be one month away. The new safety information, which is the revised part of the explanatory document, will be promptly explained to the subjects, and oral consent will be obtained. However, if the same version of the revised explanatory document is prepared by the old and new investigators, written consent using the revised version will not be obtained again until after the conclusion of the above memorandum, which will be slightly later.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Assuming that "change of investigator," "revision of investigator's summary," and "revision of explanatory document" will be reviewed by the Investigational Review Committee at the same time, the following is the concept of the method of confirming the subject's willingness to continue the study.
We think there is no problem if the new investigator and the old investigator discuss the contents of the safety information to be included in the explanatory document following the revision of the drug outline, and prepare a revised version of the explanatory document. However, as the name of the investigator to be listed in the explanatory document, it is acceptable to list only the name of the new investigator if the change of investigator is explained to subjects.
In addition, if the revision of the investigational new drug summary corresponds to "information that is deemed to influence the subject's decision on whether or not to continue participating in the clinical trial," as stipulated in Article 54, Paragraph 1 of the GCP, the investigator must promptly convey this information to the subject and confirm his/her willingness to continue participating in the clinical trial. The investigator is required to confirm the subject's willingness to continue to participate in the clinical trial. Therefore, we believe that there is no problem in confirming the subject's willingness to continue without waiting for the Trial Review Committee's deliberation, and obtaining consent again in writing using the revised explanatory document after the Trial Review Committee approves it.
Please also refer to our previous opinions on the necessity of Trial Review Committee review ( 2008-05) and the necessity of subject's re-consent ( 2011-32 ) for the revision of the explanatory document in which only the investigator's name is changed.