Post approval monitoring of research studies involving human subjects is conducted to identify possible weaknesses and elicit process improvements in human subject’s protections. This internal strategy also serves to increase investigator awareness of regulatory requirements and improve the ethical conduct of research.
Post approval monitoring may be study-oriented or investigator-oriented. Post approval monitoring that is study-oriented, also referred to as “random”, is conducted routinely as a part of human subjects protection to maintain consistency and evaluate documents that have been submitted and approved as part of the IRB process.
Post approval monitoring designated as Investigator-oriented, frequently referred to as “for cause” is based on known or suspected information regarding an investigator’s procedures in conducting a study, will involve the study in question, and can subsequently lead to audits on all active studies conducted by the investigator.
Institutions that hold an Office for Human Research Protections (OHRP) Federal Wide Assurance (FWA) are required to have procedures in place that include formal mechanisms for monitoring compliance with human subjects requirements. Post approval monitoring provides one mechanism for ensuring compliance with this requirement.