The Safety and Pharmacovigilance Team (SPT) within OPCRO serve as subject matter experts and advisors to DAIDS and external stakeholders in matters related to safety and pharmacovigilance. A cross section of DAIDS SPT responsibilities includes:

ProPEP has a two-part mandate. ProPEP staff (i) serve as the Division’s Human Subjects Protection experts, and (ii) oversee the development and maintenance of DAIDS' Clinical Research Policies by:

The DAIDS Clinical Laboratory Oversight Team (DCLOT), made up of DAIDS laboratory staff from the Vaccine, Therapeutic and Prevention Programs at DAIDS, is responsible for lab establishment, oversight and implementation of laboratory policies, evaluation of lab performance, and follow-up on lab-related issues. DCLOT members serve as Point of Contacts (POC) to each of the funded clinical trial Networks.

The DAIDS Protocol Registration Team (PRT) establishes internal procedures and processes for the DAIDS RSC Protocol Registration Office (PRO). DAIDS PRO receives and processes all protocol registration materials submitted by Clinical Research Sites (CRSs) participating in DAIDS-supported and/or -sponsored clinical trials.

As sponsor, NIAID DAIDS is required to monitor DAIDS sponsored and/or supported clinical trials to ensure protection of human subjects, accurate and complete reporting of trial data, and protocol compliance by Clinical Research Sites (CRSs), in accordance with 21 CFR §312.56 and ICH Good Clinical Practices (GCP) Section 5.18. The Monitoring Operations Branch (MOB) in the Office of Clinical Site Oversight (OCSO) directs the monitoring function for DAIDS-sponsored clinical trials to meet the rigor of all applicable regulations and guidelines.