Regulatory Support Services

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

Abstract

The Office of Clinical Research Policy and Regulatory Operations (OCRPRO) supported the conduct of 184 material and active clinical trials in FY23 from 17 NIAID laboratories and other clinical research projects by providing an array of services to ensure that FDA and other DHHS regulations were fulfilled including; (1) appropriate management of investigational new drug sponsor responsibilities; (2) data and safety board management; (3) clinical safety reporting, and; (4) clinical trial monitoring for study compliance. Additionally, OCRPRO manages over 96 Investigational New Drugs, Investigational Devices, and Master Files for studies conducted at the NIH Clinical Center, at academic medical centers throughout the US, and in 13 countries. These activities constitute a collective safety system to protect research participants and enhance the integrity of study conduct for NIAID sponsored research. OCRPRO staff continued to provide a comprehensive protocol development program to assist intramural clinical researchers in the launching of new studies.. While many of these activities took place within the context of the traditional NIAID intramural program conducted at the NIH Clinical Center, several of the actions assisted in the accomplishment of larger NIAID actions conducted through NIAID ICERs (International Centers for Excellence in Research), disease-specific networks), and programmatic networks such as the DOD Uniformed Services University Infectious Disease Clinical Research Program (IDCRP) and the Indonesia Research Partnership on Infectious Diseases (INA-RESPOND). Additionally, OCRPRO staff remained involved in supporting the Partnership for Research on Ebola Virus in Liberia (PREVAIL) as well as extension of follow-up for multi-sponsor/multi-partner PREVAC study. Further, the PALM partnership in the Democratic Republic of Congo (DRC) was another project involving OCRPRO staff with the initiation of a monkeypox therapeutic study at two sites in DRC during this time period as well as a study of MPox vaccine in healthcare workers. All OCRPRO activities were conducted with a focus on coordination of activities by the respective regulatory functions in an effort to promote the timely and effective operation of the research enterprise to include the intramural research programs in HIV, biological defense, and emerging infectious diseases. OCRPRO acts as IND sponsor for COVID studies operationalized by the INSIGHT network which is an international network of sites able to respond rapidly to emerging infectious disease (EID) outbreaks.