Extended AuditTrail recording user role changes within study

toskrip

Hi,

I would like to open a topic in this discussion in order to see if there is an interest about such feature. I came into a requirement where it would be feasible to keep and electronic audit record of changes in assigned user roles within a trial (during trial lifetime). Basically the typical audit log that stores when the change of role occurred for which user and by whom it was performed.

is anybody else interested to have something like this in OpenClinica?

best

Tomas

haensel

Hi Tomas

This sounds like a reasonable requirement since every change to the study and its configuration should be logged. I'm not aware of a request of somebody for it but this might be a question of time only.
I find it useful but have no urgent need for it.

Regards,
Christian

GerbenRienk

Hi Tomas,
Yes, I support that idea. And not only for user-rights, but also for changes to the study-status, from design to available etc, and also for the changes to the study structure: events being created, crf's assigned, removed, etc.
At various times I have been asked about this information, especially with long-running studies and/or keen auditors.
If I can help in any way, please let me know.
Gerben Rienk

jacob.rousseau

Hi Tomas,
this is a good suggestion which I also support. However this introduces a new type of logging on the study level. All the current audit-logging is done on the subject-level. In my opinion this new hierarchical level forms large chunk of work. The simple solution is writing all changes to a logfile without a presentation-layer in the user-interface.

Regards Jacob

mtaylor

Yes I would find this feature very useful so that we can provide evidence that access is given to users only in keeping with dates on the delegation logs at participating study centres

kristiak

I fully agree, specially Gerben's ideas about logging any changes to the original study design-