A07-Attachment_1_Acronyms.docx

Attachment 1 Acronyms BLA – Biologics Licensing Application KO – Contracting Officer CONUS – Continental United States COR – Contracting Officer’s Representative CRF – Case Report Form DOD – Department of Defense ELA – Establishment Licensing Application FDA – Food and Drug Administration IND – Investigational New Drug Application NDA – New Drug Application IRB – Institutional Review Board, ensures research is conducted safely and ethically OCONUS – Outside Continental United States OHRP – Office of Human Research Protections PI – Principal Investigator, a physician or scientist who has the primary responsibility for executing a Clinical study PLA Product Licensing Application SOPs – Standard Operating Procedures USAMRMC – U.S. Army Medical Research and Materiel Command that is the overseeing Command for WRAIR USAMRD-G – US Army Medical Research Directorate-Georgia WRAIR – Walter Reed Army Institute of Research