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)
General
- SOP_I-A-1_Protocol selection
- SOP_I-A-2_ Notification
- SOP_I-A-3_Establishment of Date
- SOP_I-A-4_Record Selection
- SOP_I-A-5_IRB_File
- SOP_I-A-6_Worksheets
- SOP_I-A-7_Pre-interview
- SOP_I-A-8_Consent
- SOP_I-A-9_Participant Records
- SOP_I-A-10_Regulatory
- SOP_I-A-11_Testarticle
- SOP_I-A-12_Documentation and Dissemination
- SOP_I-A-13_Report Rating
- SOP_I-A-14_Prompt Reporting