Regulatory Support Services

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications & trials

Abstract

The Office of Clinical Research Policy and Regulatory Operations (OCRPRO) supported the conduct of 249 clinical trials in FY17 by providing an array of services to ensure that FDA and other DHHS regulations were fulfilled to include investigational drug management, institutional drug management, institutional review board management, data and safety board management, clinical safety reporting, and clinical trial monitoring for study compliance. These activities constitute a collective safety system to protect research participants and enhance the integrity of study conduct for NIAID sponsored research. 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 (Influenza Research Collaboration), and programmatic networks (DoD Infectious Disease Clinical Research Program (IDCRP) and the South East Asia Research Network). Additionally, OCRPRO staff remained involved in supporting the Partnership for Research on Ebola Virus in Liberia (PREVAIL) as well as the multi-sponsor/multi-partner PREVAC study. Moreover, these 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.