Is auditing or monitoring required?
After the Institutional Review Board (IRB) has approved a SmartForm Application (PRO), the IRB has the responsibility to ensure that procedures are carried out as described in the PRO. The IRB utilizes the Quality Improvement team (QI) for monitoring research activities following approval. These include the following:
Routine reviews are a mechanism for the MCW Human Research Protection Program (HRPP) to provide internal oversight of the conduct of human research studies that are reviewed and approved by the MCW/FH IRBs.
Examples of events which may generate "For Cause" audits and an overview of the process, including determination of the need for an audit.