Drug Evaluation Committee 2020-14 Date discrepancy between "List of investigators/contractors" and Delegation Log at the end of the study
Related classification: Principal investigators, subinvestigators, etc.
Initial release date: Jul. 2020
Question
I have a question about the list of investigators/contractors and the Delegation Log.
We are assuming that we will put the end date in the Delegation Log first and issue the list of investigators/contractors later.
Due to a personnel transfer, I finished my work at the previous hospital and requested my successor to delete my name from the list of investigators and collaborators and to terminate my work in the Delegation Log. After the transfer, I was informed that they were planning to add a new investigator to the list and that the timing of removing me and adding a new investigator would be timed to coincide. Since I have already been transferred, I will not be working, but I will still remain on the list of investigators and collaborators and on the Delegation Log.
At this time, would it be okay if I terminate my duties in the Delegation Log first and issue the list of investigators and collaborators later (remove me and add a new CRC)? Or should I delete me and add a new one each time without waiting for the new addition?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Normally, there is no column in the list of investigators and collaborators to indicate the start and end dates of the work of each member of the investigational staff (investigator or collaborator). The Delegation Log, on the other hand, does not have a column for the start date of each member.
On the other hand, the Delegation Log must include the start and end dates of each staff member. Since clinical trial staff can only start their work with the approval of the site director, the start date in the Delegation Log will be after that date. The end date can be either the date when the staff member no longer actually performs the work or the date when the head of the site approves the revised list of investigators and collaborators from which the staff member has been removed. However, please make sure that the same rules and processes are used for both the start date and end date of the work, and that there are no inconsistencies in the list of investigators and research collaborators.