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Principal Investigator: Betsey Herpin
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2020
Award: $21,635,765
Funding agency: National Institute of Allergy and Infectious Diseases
The Office of Clinical Research Policy and Regulatory Operations (OCRPRO) supported the conduct of 224 active clinical trials in FY20 from 24 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) institutional review board functions; (3) data and safety board management; (4) clinical safety reporting, and; (5) clinical trial monitoring for study compliance. Additionally, OCRPRO manages 101 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 17 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. Moreover, the policy staff of OCRPRO continue to provide consultation on requirements and evaluation for an NIAID-wide quality management system. 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 Indonesia Research Partnership on Infectious Diseases (INA-RESPOND). In FY 2020, OCRPRO staff supported the extension phase of the Ebola PALM trial in the Democratic Republic of the Congo. 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. In early 2020, OCRPRO provided support to the University of Minnesota Statistical Data Management Center / INSIGHT programs for the implementation of multinational COVID-19 clinical trials. 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.
Terms: <2019 novel coronavirus><2019-nCoV><AIDS><AIDS Virus><Academic Medical Centers><Acetylsalicylic Acid><Acquired Agammaglobulinemia><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immuno-Deficiency Syndrome><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Acquired Immunologic Deficiency Syndrome><Active Follow-up><Antibodies><Area><Aspirin><Atopic Dermatitis><Atopic Eczema><Atopic Neurodermatitis><Belgian Congo><Benchmarking><Best Practice Analysis><Biological><Blood><Blood Reticuloendothelial System><Body Tissues><COVID-19><COVID19><Cellular Immune Function><Chronic Granulomatous Disease><Clinical><Clinical Research><Clinical Study><Clinical Trials><Clotting><Coagulation><Coagulation Process><Coccidioidomycosis><Collaborations><Common Variable Immunodeficiency><Communicable Diseases><Consultations><Country><Cysticercosis><Data><Deficiency Diseases><Democratic Republic of the Congo><Dengue><Devices><Disease><Disorder><Disseminated Neurodermatitis><Disseminated eosinophilic collagen disease><EBOV><East Indies><Ebola><Ebola virus><Elements><Emerging Communicable Diseases><Emerging Infectious Diseases><Ensure><Eosinophilia><Evaluation><Formulation><Fungus Diseases><Genetic><Genetic Markers><Goals><Grippe><HIV><Hepatitis><Human Immunodeficiency Viruses><Hyper-IgE Syndrome><Hypereosinophilic Syndrome><Hyperimmunoglobulin E Syndrome><Hyperimmunoglobulin E-Recurrent Infection Syndrome><IRB><IRBs><IgE><Immune><Immune system><Immunes><Immunochemical Immunologic><Immunodeficiency Disorder><Immunodeficiency Syndrome><Immunoglobulin E><Immunologic><Immunologic Deficiency Syndromes><Immunological><Immunological Deficiency Syndromes><Immunologically><Immunologics><Indonesia><Infection><Infectious Disease Pathway><Infectious Diseases><Infectious Diseases / Laboratory><Infectious Diseases Research><Infectious Disorder><Inflammatory><Influenza><Injury to Liver><Institutional Review Boards><Intramural Program><Intramural Research Program><Investigation><Investigational Drugs><Investigational New Drugs><Investigators><Job's Syndrome><LAV-HTLV-III><Leukocyte Adhesion Deficiency><Liberia><Lyme Borreliosis><Lyme Disease><Lymphadenopathy-Associated Virus><Lymphocytopenia><Lymphopenia><M tuberculosis infection><M. tb infection><M. tuberculosis infection><M.tb infection><M.tuberculosis infection><MTB infection><Malaria><Malay Archipelago><Measures><Medical><Minnesota><Modeling><Monitoring Clinical Trials><Mycobacterial Infection><Mycobacterium Infections><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><Mycoses><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Netherlands East Indies><Operations Research><Paludism><Participant><Phase><Plasmodium Infections><Policies><Predisposition><Process><Program Development><R-Series Research Projects><R01 Mechanism><R01 Program><Refractory><Regulation><Reporting><Research><Research Grants><Research Personnel><Research Project Grants><Research Projects><Researchers><Respiratory syncytial virus><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Safety><Services><Severe acute respiratory syndrome coronavirus 2><Susceptibility><Syndrome><System><TB infection><Time><Tissues><Training><Tuberculosis><United States National Institutes of Health><Universities><University Medical Centers><Virus Replication><Virus-HIV><Work><Wuhan coronavirus><ZIKA><Zaire><active followup><allergic dermatitis><allergic eczema><allergic/immunologic body system><allergic/immunologic organ system><clinical center><common variable immune deficiency><common variable immuno-deficiency><corona virus disease 2019><coronavirus disease 2019><data management><disseminated TB><disseminated tuberculosis><ebolavirus><flu infection><follow up><follow-up><followed up><followup><fungal infection><fungus infection><genetic biomarker><hepatic damage><hepatic injury><hypoimmunity><immune deficiency disorder><immune function><immune reconstitution><immunodeficiency><infection due to Mycobacterium tuberculosis><infection recurrence><influenza infection><international center><liver damage><liver injury><non-tuberculosis mycobacteria><non-tuberculosis mycobacterial><non-tuberculous mycobacteria><non-tuberculous mycobacterial><nontuberculosis mycobacterial><nontuberculous mycobacteria><nontuberculous mycobacterial><operation><programs><protocol development><recurrent infection><response><success><tuberculosis infection><tuberculous spondyloarthropathy><viral multiplication><viral replication><virus multiplication>