eResearch Regulatory Management (eRRM) was updated on April 19, 2021 to version 4.5. System changes in this release include the following:
HUM Application, Amendment
- THIS HAS BEEN POSTPONED INDEFINITELY - Beginning May 3, 2021, studies with No Continuing Review that include interaction/intervention with subjects must submit an Annual Status Report.
- A new IRBMED Approval Letter template for Not Regulated Quality Assurance/Quality Improvement (QA/QI) studies was created.
IRB Approval Letter templates were updated to reflect the requirement of 5 days to report action in an AE/ORIO or Amendment.
Core IRB Staff and Committee Members
The requirement to add a Vote Time in the Update Meeting History activity was removed.