Drug Evaluation Committee 2015-46 Temporary Leave of Absence for Clinical Trial Collaborators during Clinical Trials
Related classification: Principal investigators, subinvestigators, etc.
Date of first publication: 04/2016
Question
If a clinical trial collaborator takes a leave of absence due to maternity leave or other reasons during a clinical trial, do we need to temporarily remove her from the list of investigators and clinical trial collaborators and delete all vendor-related accounts as well? It depends on the length of the leave, but if the return date is known and it is at the end of the clinical trial, then of course it would be necessary to delete the accounts, but if the return date is not known, it would not be necessary to delete them.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If it is clear that the collaborator will not return to the study before the end of the study period, we think it is necessary to delete the investigator from the list of investigators and collaborators. On the other hand, if it is assumed that the investigator will return to work during the clinical trial period, we believe that it is sufficient to determine the necessity of removing the investigator from the list after considering the continuity of the current duties and the implementation system including the successor who is on leave.
However, with regard to computer system accounts, it is considered a security issue to keep the accounts of those who are not likely to use the system for a certain period of time, and therefore, the need to delete or disable the accounts should be determined after considering the policy of the system owner, the sponsor, and other factors. Therefore, the necessity of deleting or deactivating the account should be determined after considering the policy of the sponsor, who is the system owner.
We do not see any problem in deleting accounts in the computer system without deleting them from the list of investigators and collaborators.