Drug Evaluation Committee 2008-05 Review by the Clinical Trial Review Committee of a Revised Explanatory Document for a Change of Principal Investigator
Related classification: Clinical Trial Review Committee
Date of first publication: August 2008
Question
The secretariat requested that the name and affiliation of the investigator be blank and reviewed by the IRB because a change in the investigator is scheduled in three months. I felt that there was no problem, as the IRB would confirm whether there were any changes in the information when the investigator was changed. I was told that blanks are acceptable for the investigators, but what do you think?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As you know, the investigator is required to prepare the explanatory document (GCP Article 51, Paragraph 1). Therefore, in this case, the new investigator needs to confirm the contents of the explanatory document when the investigator is changed. If the new investigator determines that there is no need to change the contents of the explanatory document already approved by the investigator review committee (i.e., if only the investigator's name is changed), then it would be of minimal significance for the investigator review committee to review this itself.
There is no problem in leaving the section for the investigator in charge blank in the explanatory document and entering the actual investigator in charge approved by the Investigational Review Committee when explaining to the subject.
In this case, it is assumed that the current investigator knows before the start of the clinical trial that he/she will be unable to continue his/her responsibilities after 3 months. We think it is important to discuss with the investigator and the site in advance that the investigator has enough time to conduct the clinical trial (GCP Article 42) and that a successor investigator can be selected promptly.