21 Jun Important Cutover Notes for T1G1 Study Teams
There are a number of upcoming process changes that will affect study teams in T1G1. These study teams should:
- Stop submitting new studies to CRS by end-of-day on July 6
- Submissions will resume on July 16 in OnCore and directly to CC-IRB
- Between July 9-13, if an exception is needed to submit a study (e.g., includes expanded access, compassionate use), contact regulatoryaffairs@fredhutch.org and iro@fredhutch.org
- Stop entering subject enrollment and status changes in PATS and Epic after 5:00 PM on Thursday July 12
- CRS will stop issuing Consortium Protocol Numbers for T1G1 after end-of-day on July 6
- Start submitting amendments and renewals directly to IRB on Monday July 9
- Continue to submit reportable events directly to irbinbox@fredhutch.org
- Continue submitting DSMC renewals via email to CRS