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