Hi all,

I have an upcoming audit with a sponsor, and I am a very nervous/concerned about having an audit finding related to timely notification to sites of updated IB and ICF from CRA. I missed the original email notification from the project lead on their approval, and did not get notification sent out to sites until the original notification email was followed up on by the project lead almost 3 weeks later.

All of my sites are in the beginning stages of identifying subjects to screen/enroll, and none have enrolled/screened any subjects yet. So, it will not be an issue that any subjects were consented with an outdated ICF, thank God.

I know that sites being provided most recent IB and ICF is something that auditors and inspectors look for.

How big was my screw up? What timeline is acceptable for notification of new approved IB/ICF?