Good Clinical Practice Guide
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Thread: Electronic Delegation Logs

  1. #1

    Electronic Delegation Logs

    Hello everyone,

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

    Advantages

    • 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.


    Disadvantages
    • 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!

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Posts
    121
    Just a few ideas:-
    Will the log require electronic signature by the PI if there is no longer a wet ink signature. Obviously it is a problem if passwords are shared such that others could have writing rights, this process should be made very secure indeed with identification of the author.

    Also you need to plan for “read-only” access for Inspectors (readily available and freely accessible) as well as monitors/auditors.
    How is “read-only” access maintained?
    How is the log maintained so that no unauthorised changes are made?
    Is the log and audit trail [of all changes and accesses (etc)] maintained securely and always available together (i.e. log and audit trail always bound together)? When the delegation log is archived by the investigator/institution (and also the sponsor copy archived with the sponsor) will they be archive according to GCP requirements and be readily available and readable for 25 years?
    Making sure that the audit trail of the log, is readily available and easily accessible in a “read-only” format for monitors/auditors/inspectors to see on their visits.

    Surely only the PI can approve the delegation of a trial related task? The PIs is required to perform all tasks themselves, unless they delegate tasks (& document PI oversight) to appropriate team personnel, who are documented as being qualified by education, training and experience, to carry out those tasks.
    Make sure that the PI not only prospectively and contemporaneously approves properly qualified and TRAINED team members, but also rescind/withdraw that delegation if personnel are non-compliant or are no longer performing that task. It is often found that personnel are delegated a task, but never have that duty withdrawn from them even when they are no longer working on the trial.

    If it is also combined with a signature log then there will be other concerns about access and secure authentication. Will there be any paper documentation? If so then there may be a need for both a paper (wet ink) signature log as well as an electronic one.

    Documented oversight of all trial personnel and tasks is vitally important (see ICH E 6 R2).

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