The Office of Clinical Research Policy and Regulatory Operations (OCRPRO) supported the conduct of 218 clinical trials in FY15 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 were substantially involved in supporting the NIAID Ebola Clinical Research response both domestically and in West Africa. 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.
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|Pierson, Jerome F; Kirchoff, Matthew C; Orsega, Susan M et al. (2017) Collaboration of the NIH and PHS Commissioned Corps in the International Ebola Clinical Research Response. Fed Pract 34:18-25|
|Kirchoff, Matthew Carl; Pierson, Jerome F (2017) Considerations for Use of Investigational Drugs in Public Health Emergencies. Ther Innov Regul Sci 51:146-152|
|Pierson, Jerome F; Kirchoff, Matthew Carl; Tyee, Rev Tijli et al. (2017) Establishment of a research pharmacy to support Ebola clinical research in Liberia. J Am Pharm Assoc (2003) 57:542-546|
|Zuckerman, Judith; van der Schalie, Barbara; Cahill, Kelly (2015) Developing training for Data Safety Monitoring Board members: A National Institute of Allergy and Infectious Diseases case study. Clin Trials 12:688-91|