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SOCRA Abbreviations
SOCRA CCRP Abbreviations
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07/12/2019
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Term
IND
 Definition
Investigational New Drug
Term
NDA
 Definition
New Drug Application
Term
FDA
 Definition
Food and Drug Administration
Term
OHRP
 Definition
Office for Human Research Protections
Term
DHHS
 Definition
Department of Health and Human Services
Term
HHS
 Definition
Health and Human Services
Term
IRB
 Definition
Institutional Review Board
Term
IDE
 Definition
Investigational Device Exemption
Term
PMA
 Definition
Pre-Market Approval
Term
CDER
 Definition
Center for Drug Evaluation and Research
Term
CBER
 Definition
Center for Bioethics Evaluation and Research
Term
CDRH
 Definition
Center for Devices and Radiological Health
Term
OCP
 Definition
Office of Clinical Pharmacology
Term
CVM
 Definition
Center for Veterinary Medicine
Term
ORI
 Definition
Office of Research Integrity
Term
FWA
 Definition
Federal Wide Assurance
Term
ICH
 Definition
International Conference on Harmonization
Term
CRA
 Definition
Clinical Research Associate
Term
CRC
 Definition
Clinical Research Coordinator
Term
CRO
 Definition
Contract Research Organization
Term
UPIRSO
 Definition
Unanticipated Problem Involving Risks to Subjects or Others
Term
UP
 Definition
Unanticipated Problem
Term
AE
 Definition
Adverse Event
Term
SAE
 Definition
Serious Adverse Event
Term
VAI
 Definition
Voluntary Action Indicated
Term
OAI
 Definition
Official Action Indicated
Term
NAI
 Definition
No Action Indicated
Term
CIP
 Definition
Certified IRB Professional
Term
DMC
 Definition
Data Monitoring Committee
Term
DoH
 Definition
Department of Health
Term
GCP
 Definition
Good Clinical Practices
Term
CRF
 Definition
Case Report Form
Term
HSP
 Definition
Human Subject Protections
Term
CFR
 Definition
Code of Federal Regulations
Term
DSMB
 Definition
Data Safety Monitoring Board
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