Is it possible to add a field to a report which indicates whether the audit trail was reviewed or not, and by which user?
I know that you can draw an audit trail report, but our audit trails can be 80 pages long! So if we can just add a field to one of our other reports that will indicate whether or not the audit trail for a results set was reviewed, then we won't need to print out the 80 page audit trail and can just keep a digital copy on file.
With CDS 2.5 a work around is to use the e-signature rules to force an audit trail e-signature before an instrument user is allowed to apply their signature regarding the results. This example will assume the person performing the audit trail review isn't the same person that would traditionally sign a result set. This procedure will be SOP based with some software controls enforcing the order of signatures being performed.
First at the Project level setup the rules to enforce a signature order with the Audit Trail Reviewer as the first step in the process. If preferred, an automatic lock of the data files can be enforced at step 1 to ensure the results aren't changed after the Audit Trail Reviewer has signed off. For step 2 the person for your company who traditionally signed the result set is allowed to sign, and so on and so on for any follow up steps.
Below is a an example screenshot. In case it is difficult to make out, the default meaning I gave the Audit Trail Approver is "I have reviewed the audit trail".
Depending how tightly one wants to control this process, one can modify the steps even further. Such as instrument user performs the first sign off and the results set lock, then step 2 is audit trail reviewer reviews the audit trails and then signs off, then the instrument user performs a sign off at step 3 again before going further up the chain of approvals.
Please keep in mind setting something up like this is a way of putting in a procedural control to get the outcome you want. In this case the e-signature by the audit trail reviewer means only they confirm the audit trail was reviewed by them, not that the results of the injections are valid or pass any sort of criteria. The instrument user signature is what represents the results are valid or pass some sort of criteria. Side bonus, now that the audit trail reviewer was made a part of the e-signature process, when you print an e-signature report you have your indication that the result set audit trail was reviewed without printing out the 80 page audit trail. Which was a goal of the original post.
This is just an example of what the CDS 2.5 software is capable of. Run any procedures by your QA or validation department for validation if you are in a regulated environment.
