eRRM: Have an In-Progress Submission Returned to Study Team for Editing (HUM/AME/ADV/CR) in eResearch Regulatory Management

Environment

eResearch Regulatory Management (eRRM)

Issue

After a study has been submitted for review, the study team may want it returned for further edits.  (HUM/AME/ADV/CR) 

Resolution

Study teams are only permitted to edit submissions (HUM/AME/ADV/CR) when they are in the following states:

  • Pre-Submission
  • Changes Requested by <ANY Committee or Reviewer>
  • Changes Required by <ANY Committee or Reviewer>
  • Contingencies Pending 

In all cases where a study team needs to have a submission returned to make edits, the study team must post correspondence and request that the committee currently reviewing the submission return the submission for changes.

To ensure the current reviewing committee receives email notification of the correspondence, please check the box for the reviewing committee at the bottom of the Post Correspondence activity window.

Additional Information

See the Post Correspondence step-by-step procedure.