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Contact the NIAID News & Science Writing Branch.
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.
Welcome to the DAIDS Group Training Pages on the DAIDS Learning Portal. Please use the links below to visit dedicated landing pages for selected groups within DAIDS. You will find general information about each group and a list of related DLP trainings
DCLOT oversees laboratories at all DAIDS Clinical Research Sites (CRSs). Please see this page for lab related trainings from DAIDS.
PAB establishes and oversees requirements for DAIDS-supported pharmacies and the use of study products associated with DAIDS-supported and/or -sponsored clinical trials. Please see this page for more information about PAB and a list of related training offerings on the DLP.
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. Please see this page for more information about MOB and a list of monitoring related training offerings on the DLP.
OPCRO groups include Protocol Registration Team (PRT), DAIDS Protection of Participants, Evaluation and Policy (ProPEP) Branch, and DAIDS Safety and Pharmacovigilance Team (SPT). Please follow the link to the OPCRO page to see an introduction for each group and lists of related training offerings on the DLP.
A pre-exposure prophylaxis (PrEP) regimen containing an investigational long-acting form of the HIV drug cabotegravir injected once every eight weeks was safe and more effective than a daily oral PrEP regimen at preventing HIV acquisition among a group of cisgender women. The women, from southern and east Africa, are enrolled in a clinical trial sponsored by the National Institutes of Health.
Submit a Media Request
Contact the NIAID News & Science Writing Branch.
Submit a Media Request
Contact the NIAID News & Science Writing Branch.