Examination of Clinical Trial Costs and Barriers for Drug Development. List of Acronyms


Acronym Meaning

AIDS  Acquired immunodeficiency syndrome 
ASPE  Office of the Assistant Secretary of Planning and Evaluation 
BLA  Biologic License Application 
BLS  U.S. Bureau of Labor Statistics 
CDER  Center for Drug Evaluation and Research 
CFR  Code of Federal Regulations 
CPI  Consumer Price Index 
CRA  Clinical research associate 
CRF  Case report form 
CRN  Clinical Resource Network 
CRO  Contract research organization 
CSDD  Center for the Study of Drug Development (Tufts University) 
CTA  Clinical trial alert 
CTFG  Clinical Trials Facilitation Group 
CTTI  Clinical Trials Transformation Initiative (Duke University) 
EDC  Electronic data capture 
EHR  Electronic health records 
EMA  European Medicines Agency 
EMR  Electronic medical record 
ERB  Ethical Review Board 
ERG  Eastern Research Group, Inc. 
EU  European Union 
FDA  U.S. Food and Drug Administration 
FY  Fiscal Year 
GCP  Good Clinical Practice 
HHS  U.S. Department of Health and Human Services 
HIPAA  U.S. Health Insurance Portability and Accountability Act 
HIV  Human immunodeficiency virus 
ICH  International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
IND  Investigational New Drug 
IOM  Institute of Medicine 
IRB  Institutional review board 
KOL  Key opinion leader 
MIT  Massachusetts Institute of Technology 
MRI  Magnetic resonance imaging 
NCI  National Cancer Institute 
NDA  New Drug Application 
NIH  National Institutes of Health 
NME  New molecular entity 
NPV  Net present value 
OCR  Office for Civil Rights 
OHRP  Office for Human Research Protections 
PDUFA  Prescription Drug User Fee Act 
POETIC  Pediatric Oncology Experimental Therapeutics Investigators Consortium 
PRO  Patient-reported outcome 
SAE  Serious Adverse Event 
SDV  Source data verification 
SOP  Standard operating procedure 
VHP  Voluntary Harmonisation Procedure (European Union) 
WACC  Weighted average cost of capital 


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