Policies and Procedures

The Education and Compliance Support for Human Subject Research (ECS-HSR) Policies and Procedures are applicable to Food and Drug Administration (FDA) regulated Investigational New Drug (IND) and Investigational Device Exemption (IDE) held by qualified University of Pittsburgh faculty members (i.e., University-based).  The ECS-HSR Standard Operating Procedures (SOPs) are utilized by the Division for internal day-to-day operations. 

The ECS-HSR: Policies and Procedures 

The ECS-HSR: Standard Operating Procedures

Compliance Activity Review Subcommittee (CARS)