Abstract

RCHSPB supported the conduct of 79 clinical trials through 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.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Clinical Support Services Intramural Research (ZID)
Project #
1ZIDAI009001-01
Application #
7970178
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2009
Total Cost
$10,312,316
Indirect Cost

  Institution

Name
National Institute of Allergy and Infectious Diseases
Department
Type
DUNS #
City
State
Country
Zip Code

  Publications

Lévy, Yves; Lane, Clifford; Piot, Peter et al. (2018) Prevention of Ebola virus disease through vaccination: where we are in 2018. Lancet 392:787-790
Larson, Gregg S; Baseler, Beth R; Hoover, Marie L et al. (2017) Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency. Am J Trop Med Hyg 97:10-15
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