COMMONLY USED ABBREVIATIONS AND TERMS in CLINCAL TRIALS
Abbreviation
ADR
AE
AUC
BLA
BUN
CAP
CBER
CDER
CDRH
CFR
CI
CLIA
Cmax
Cmin
CNT
Cr
CRA
CRC
CRF
CRO
CT
CTA
CTC
CTCAE
CYP
DAR
DHEA
DLT
DNA
DSMB
DSMP
Definition
Adverse Drug Reaction
Adverse Event
Area Under the Curve
Biologic Licensing Application
Blood Urea Nitrogen
College of American Pathologists
Center for Biologics Evaluation
and Research (FDA)
Center for Drug Evaluation and
Research (FDA)
Center for Devices and
Radiological Health (FDA)
Code of Federal Regulations
Confidence Interval
Clinical Laboratory Improvements
Amendments
Maximum Plasma Concentration
Minimum Plasma Concentration
Consented but Not Treated
Serum Creatinine
Clinical Research Associate
Clinical Research Coordinator
Case Report Form
Contract Research Organization
Computed Tomography
Clinical Trials Agreement
Circulating Tumor Cell Count
Common Terminology Criteria for
Adverse Events
Cytochrome P450
Drug or Device Accountability
Records
Dihydroepiandrosterone
Dose Limiting Toxicity
Deoxyribonucleic Acid
Data Safety Monitoring Board
Data Safety Monitoring Plan
EC
Ethics Committee
ECG
ECOG
Electrocardiogram
Eastern Cooperative Oncology
Group (Used to determine
Performance Status )
Electronic Data Capture
European Agency for the
Evaluation of Medicinal Products
Food and Drug Administration
Federal Wide Assurance number
(number assigned to IRB )
Good Clinical Practices
Good Laboratory Practices
Good Manufacturing Practices
Health Assessment Questionnaire
Humanitarian Device Exemption
(must be in place to use a HUD)
Humanitarian Use Device (for less
than 4, 000 subjects)
Investigator’s Brochure
Informed Consent Form
International Conference on
Harmonization
Inhibitory Concentration 50%
Investigational Device Exemption
Independent Ethics Committee
Investigational New Drug
Institutional Review Board
Injection Site Reaction
Intent-to-Treat
Interactive Voice Recognition
System
Inhibition Constant
Lactate Dehydrogenase
Medical Device Reporting
Medical Dictionary for Regulatory
Activities
Millimeters of Mercury
Medical Outcomes Study
Maximum Tolerated Dose
New Drug Application
EDC
EMEA
FDA
FWA number
GCP
GLP
GMP
HAQ
HDE
HUD
IB
ICF
ICH
IC50
IDE
IEC
IND
IRB
ISR
ITT
IVRS
Ki
LDH
MDR
MedDRA
mmHg
MOS
MTD
NDA
NSR
Tbili
TK
t1/2
TTP
WBC
WHO
Non-Significant Risk ( usually
refers to device research )
Office for Human Research
Protection
Pharmacodynamics
Progression-Free Survival
Principal Investigator
Pharmacokinetic
Pre- Market Approval
Post Marketing Surveillance
As Needed
Quality of Life
QT Interval Corrected by the
Fridericia Correction Formula
Response Evaluation Criteria in
Solid Tumors (Oncology )
Serious Adverse Event
Standard Deviation
Source Document Verification
Standard Error for the Mean
Site Evaluation Visit
Site Initiation Visit
Significant Risk (usually refers to
device research)
Total Bilirubin
Toxicokinetics
Half-Life
Time To Progression
White Blood Cell Count
World Health Organization
WMA
World Medical Association
OHRP
PD
PFS
PI
PK
PMA
PMS
prn
QOL
QTcF
RECIST
SAE
SD
SDV
SEM
SEV
SIV
SR