CRIO: Navigating Potential eRegulatory Issues
As you know, DelRicht has moved to an eRegulatory platform. While it is exciting being one of the first Sites to convert to electronic, it has introduced a few new (potential) nuances. It is our goal to work with each CRA to iron out any issues not only for our Site, but for the industry as a whole.
Listed below are issues that have been brought to our attention as well as any solutions and suggestions:
- Issue 1: How to download
- Issue 2: Length of Delegation Log
- Solution: The CRIO generated delegation is lengthy as it shows the audit trail of when each delegation is signed off on. The first four pages of the delegation log will have all the information a paper-based log would have.
- Issue 1: Location
- Issue 2: Location of general certificates and CVs
- Issue: Why are the signatures attached to a separate page?
- When a document is downloaded from CRIO, the signature shows up on a separate page – system design. However, when you are logged into CRIO, you can see the audit trail of that document and when the signature was obtained.
Downloading documents with signatures
- Issue: How to download documents
- Solution: Video Link
- Issue: Account does not appear to be active/can’t access study
- Solution: Reach out to the DelRicht team (insert Regulatory or Start Up contact). They will be able to “turn on” your account for your visit.
- Issue: How can we prove everything is compliant with FDA Guidelines?
- The Regulatory Team will be able to provide you with the appropriate documentation and certification including the Statement of Compliance and FDA Intent of Use
How to view different versions of a document:
- Issue: I can see the current version of a document (e.g. Medical License), but where is the previous version?