Post Submission

This page describes the scenarios that could arise after protocol submission or follow-on submission from the PI and study staff perspective.


Clarification Requested

During multiple steps of the IACUC approval process, the IACUC office or committee may request clarification. There can be notes in the clarification request, as well as in the protocol itself.

Comments in the protocol from IACUC staff or committee can be seen with comment bubbles on each smart form and question. The Investigator should see all comments and respond to any that are response required. Once any requested changes have been made, the Investigator can submit their clarification.


Modification Required

If modifications are required on a protocol after member or committee review, the Investigator will get a modifications required letter.  The Investigator will get an email notification and protocol will show in “modifications required” status. As with clarifications requested, the Investigator should read and respond to any comments on the protocol or within the mods required letter. After any changes have been made, the Investigator can submit their response.


Approval Withheld

If a protocol goes through Full Committee Review (FCR) and approval is withheld, the Investigator will receive a letter and the protocol will move to modifications required for the Investigator to make all of the appropriate changes and resubmit when ready. Approval withheld differs from modifications required because the protocol will now re-enter pre-review when the protocol is resubmitted.


Approved

If a protocol is approved through DMR or FCR, the Investigators will receive a notification and the protocol will move to Review Complete.


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