Drug Evaluation Committee 2020-14 Date discrepancy between "List of investigators/contractors" and Delegation Log at the end of the study
Related classification: 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/contractors 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?
JPMA's Opinion
The investigator must submit the list to the head of the Investigator Site as soon as possible after any change in staff (addition of a new member or deletion of an existing member) because there is usually no space in the list of investigators and collaborators to indicate the start and end dates of each staff member (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 work upon approval of the Investigator Site Director, the start date in the Delegation Log is the date on which the staff member starts work. The end date can be either the date when the staff member no longer performs the work, or the date when the Investigator Site Director approves the revised list of investigators and research collaborators from which the staff member was 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.