Clinical Abbreviations Flashcards

1
Q

ACRP

A

Association of Clinical Research Professionals

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2
Q

ADE

A

Adverse Drug Experience

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3
Q

ADR

A

Adverse Drug Reaction

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4
Q

AE

A

Adverse Event

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5
Q

ARO

A

Academic Research Organization

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6
Q

BLA

A

Biologic License Application

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7
Q

CBER

A

Center for Biologics Evaluation and Research

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8
Q

CDER

A

Center for Drug Evaluation and Research

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9
Q

CEC

A

Clinical Endpoints Committee

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10
Q

CFR

A

Code of Federal Regulations

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11
Q

CRA

A

Clinical Research Associate

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12
Q

CRC

A

Clinical Research Coordinator

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13
Q

CRF

A

Case Report Form

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14
Q

CRO

A

Clinical Research Organization

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15
Q

CSR

A

Clinical Study Report

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16
Q

DCF

A

Data Clarification Form

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17
Q

DHHS

A

Department of Health and Human Services

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18
Q

DIA

A

Drug Information Association

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19
Q

DSMB

A

Data and Safety Monitoring Board

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20
Q

EC

A

Ethics Committee

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21
Q

eCRF

A

electronic Case Report Form

22
Q

EDC

A

Electronic Data Capture

23
Q

FDA

A

Food and Drug Administration

24
Q

FWA

A

Federalwide Assurance

25
Q

GCP

A

Good Clinical Practice

26
Q

GLP

A

Good Laboratory Practices

27
Q

GMP

A

Good Manufacturing Practice

28
Q

HIPAA

A

Health Insurance Portability and Accountability Act

29
Q

ICH

A

International Conference on Harmonisation

30
Q

IDE

A

Investigational Device Exemption

31
Q

IEC

A

Independent Ethics Committee

32
Q

IND

A

Investigational New Drug

33
Q

IRB

A

Institutional Review Board/Independent Review Board

34
Q

IVRS

A

Interactive Voice Response System/Service

35
Q

NDA

A

New Drug Application

36
Q

NIH

A

National Institutes of Health

37
Q

OHRP

A

Office for Human Research Protections

38
Q

PHI

A

Protected Health Information

39
Q

PI

A

Principal Investigator

40
Q

PMA

A

Premarket Application

41
Q

PMN

A

Premarket Notification [501(k)]

42
Q

PMS

A

Postmarketing Surveillance

43
Q

QA

A

Quality Assurance

44
Q

QI

A

Quality Initiative

45
Q

QOL

A

Quality of Life

46
Q

RCT

A

Randomized Controlled Trial

47
Q

REB

A

Research Ethics Board (Canada)

48
Q

SAE

A

Serious Adverse Event

49
Q

SMO

A

Site Management Organization

50
Q

SoCRA

A

Society of Clinical Research Associates

51
Q

SOP

A

Standard Operating Procedure

52
Q

WMA

A

World Medical Association