One question we often get relates to disabling Oracle Clinical (OC) and Remote Data Capture (RDC) accounts. What happens to the OC/RDC accounts of users who separate from a company or roll off of a clinical trial?
The answer is relatively simple, though not necessarily obvious, because the only way to tell if an account is active is by querying the back-end tables in OC/RDC.
In cases where a user separates from the company, we recommend that the sponsor or CRO expires the password and locks the account (accounts are never removed from the system). This process is typically initiated with a request to the system administrator to disable the account. It’s important to note that disabled/inactive accounts are still associated with and viewable in study and/or site records via the audit trail. When study/site access is not removed for locked accounts, accounts will appear active within the application. And again, the only way to tell the true account status is to query the back-end.
In the other situation, when a site coordinator, principal investigator, or CRA completes a study and still needs access to other ongoing studies, the solution is different. We recommend that the study/site privileges for those users are removed from completed studies and added to other studies/sites, as necessary.
If you have questions about best practices for OC/RDC user accounts at your organization, drop us a line. We’d love to help!
