Internally monitoring and self-auditing human research studies is a valuable way for researchers to ensure that participants’ rights, safety and welfare are protected and that the research is conducted in accordance with the approved research plan and documented according to best practices.
- The Key Elements for Monitoring Adherence (PDF) guides researchers in a holistic review of their studies.
- The Self-Audit Tool (DOC) is designed to help researchers document their internal review processes.
- The Screening and Enrollment Log Guide and Template allow researchers to capture participant enrollment information in a consistent and concise manner.
This entire toolkit is intended to be manipulated by researchers to fit their studies. Any non-compliance discovered during a self-audit should be reported to HRPO in accordance with their reporting guidelines.