20 Aug Important Go-Live Preparation Steps for T1G2 Study Teams
TARGET 1 GROUP 2 GOES LIVE ON MONDAY, SEPTEMBER 17, 2018
In preparation for the go-live, some process changes will be in place as early as September 7. Study teams must familiarize themselves with the dates when mandatory changes will occur for study documentation and submission processes.
| Date | Changes |
|---|---|
| September 7 | For studies submitted to CRS: STOP new study submissions; resume in OnCore and directly to FH/CC-IRB on Sep 17 CRS will STOP issue of Consortium Protocol Numbers for T1G2 For studies submitted directly to FH/CC-IRB: STOP new study submissions; resume in OnCore and directly to FH/CC-IRB on Sep 17 For studies with billing activity: CRBB will STOP issue of RG#s |
| September 10 | Start submitting amendments, renewals and reportable events directly to IRB irbinbox@fredhutch.org |
| September 10-14 | If an exception is needed to submit a study (e.g., includes expanded access, compassionate use), contact regulatoryaffairs@fredhutch.org and iro@fredhutch.org |
| September 12 (at 5 PM) | Stop entering enrollment updates in PATS and Epic (as applicable) |
| September 17 | Resume enrollment updates in OnCore only Start submitting new IRB applications directly to irbinbox@fredhutch.org |
| Unchanged Processes: Continue sRAMP submissions for any study that already has a Consortium Protocol Number Continue submitting DSMC renewals via email to CRS |
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