Clinical Abbreviations Flashcards by Keowanna Hedgepeth | Brainscape

Q

ACRP

A

Association of Clinical Research Professionals

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Q

ADE

A

Adverse Drug Experience

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Q

ADR

A

Adverse Drug Reaction

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Q

AE

A

Adverse Event

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Q

ARO

A

Academic Research Organization

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Q

BLA

A

Biologic License Application

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Q

CBER

A

Center for Biologics Evaluation and Research

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Q

CDER

A

Center for Drug Evaluation and Research

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Q

CEC

A

Clinical Endpoints Committee

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Q

CFR

A

Code of Federal Regulations

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Q

CRA

A

Clinical Research Associate

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Q

CRC

A

Clinical Research Coordinator

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Q

CRF

A

Case Report Form

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Q

CRO

A

Clinical Research Organization

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Q

CSR

A

Clinical Study Report

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Q

DCF

A

Data Clarification Form

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Q

DHHS

A

Department of Health and Human Services

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Q

DIA

A

Drug Information Association

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Q

DSMB

A

Data and Safety Monitoring Board

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Q

EC

A

Ethics Committee

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Q

eCRF

A

electronic Case Report Form

Q

EDC

A

Electronic Data Capture

Q

FDA

A

Food and Drug Administration

Q

FWA

A

Federalwide Assurance

Q

GCP

A

Good Clinical Practice

Q

GLP

A

Good Laboratory Practices

Q

GMP

A

Good Manufacturing Practice

Q

HIPAA

A

Health Insurance Portability and Accountability Act

Q

ICH

A

International Conference on Harmonisation

Q

IDE

A

Investigational Device Exemption

Q

IEC

A

Independent Ethics Committee

Q

IND

A

Investigational New Drug

Q

IRB

A

Institutional Review Board/Independent Review Board

Q

IVRS

A

Interactive Voice Response System/Service

Q

NDA

A

New Drug Application

Q

NIH

A

National Institutes of Health

Q

OHRP

A

Office for Human Research Protections

Q

PHI

A

Protected Health Information

Q

PI

A

Principal Investigator

Q

PMA

A

Premarket Application

Q

PMN

A

Premarket Notification [501(k)]

Q

PMS

A

Postmarketing Surveillance

Q

QA

A

Quality Assurance

Q

QI

A

Quality Initiative

Q

QOL

A

Quality of Life

Q

RCT

A

Randomized Controlled Trial

Q

REB

A

Research Ethics Board (Canada)

Q

SAE

A

Serious Adverse Event

Q

SMO

A

Site Management Organization

Q

SoCRA

A

Society of Clinical Research Associates

Q

SOP

A

Standard Operating Procedure

Q

WMA

A

World Medical Association