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

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