Hello everyone,

I work with a UK site which has suggested we use their electronic delegation log rather than the normal paper log.


  • the pages cannot be physically "lost" and can be updated from any location in the hospital (I understand Trust computers must be used to access the system and these cannot be accessed at home)
  • the end result is much cleaner and the audit trail is much clearer
  • easier for contemporaneous updates. PI is championing the move to eDLs so I expect will be happier to sign people/updates off in real-time.

  • unclear regulatory requirements
  • password protection must be very strong

Is this something others have come across before, and if so could you let me know whether you have received push back from Sponsors/Auditors and what we need to know from the site in terms of the specifications? The questions I have for the site so far are:

  • Will there be a separate signature log?
  • How are Auditors/CRAs provided with access to the working log before the end of the study?
  • How are Sponsors provided with access to the final log at the end of the study?
  • Will we be able to view the audit trail for all changes made?
  • Can any team member make changes to the delegation log?
  • Can we request the addition of different tasks depending on study requirements?

Help much appreciated!