Version 4.5

April 19, 2021

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.

AE/ORIO, Amendment

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.