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Clinical Research > Acronyms > Flashcards

Acronyms Flashcards

1
Q

ADR

A

Adverse Drug Reaction

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2
Q

AEs

A

Adverse Events

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3
Q

ALCOA

A

Attributable, Legible, Contemporaneous, Original, Accurate

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4
Q

BIMO

A

Bioresearch Monitoring

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5
Q

BLA

A

Biologics License Application

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6
Q

CAPA

A

Corrective Action/Preventive Action

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7
Q

CBC

A

Complete Blood Count

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8
Q

CBER

A

Center for Biologics Evaluation and Research

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9
Q

CDA

A

Confidential Disclosure Agreement

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10
Q

CDER

A

Center for Drug Evaluation and Research

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11
Q

CDRH

A

Center for Devices and Radiological Health

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12
Q

CDSCO

A

Central Drug Standard Control Organization

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13
Q

CFR

A

Code of Federal Regulations

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14
Q

cGMP

A

Current Good Manufacturing Practices

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15
Q

cGTP

A

Current Good Tissue Practice

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16
Q

CIOMS

A

Council for International Organizations of Medical Sciences

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17
Q

CMS

A

Centers for Medicare and Medicaid Services

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18
Q

CoC

A

Certificate of Confidentiality

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19
Q

CPT

A

Current Procedure Terminology

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20
Q

CRA

A

Clinical Research Associate

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21
Q

CQMP

A

Clinical Quality Management Plan

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22
Q

CRFs

A

Case Report Forms

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23
Q

CRO

A

Clinical Research Organization

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24
Q

CV

A

Curriculum Vitae

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25
Q

DBT

A

Department of Biotechnology

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26
Q

DCC

A

Drug Consultative Committee

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27
Q

DMAC

A

Drugs Medical Advisory Committee

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28
Q

DOJ

A

Department of Justice

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29
Q

DSMB

A

Data Safety Monitoring Board

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30
Q

DTAB

A

Drugs Technical Advisory Board

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31
Q

EC

A

Ethics Committee

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32
Q

eCRF

A

Electronic Case Report Form

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33
Q

EDC

A

Electronic Data Capture System

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34
Q

EHR

A

Electronic Health Record

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35
Q

EKG

A

Electrocardiogram

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36
Q

EMA

A

European Medicines Agency

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37
Q

ePHI

A

Electronic Protected Health Information

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38
Q

ESCs

A

Embryonic Stem Cells

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39
Q

EU

A

European Union

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40
Q

FDA

A

US Food and Drug Administration

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41
Q

FIH

A

First In Human

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42
Q

Form FDA 1572

A

Statement of the Inspection

43
Q

Form FDA 482

A

Notice of Inspection

44
Q

Form FDA 483

A

Statement of Observation

45
Q

FWA

A

Federal Wide Assurance

46
Q

GCP

A

Good Clinical Practice

47
Q

HCT/P

A

Human Cell Tissue/Products

48
Q

hESC

A

Human Embryonic Stem Cells

49
Q

HHS

A

US Department of Health and Human Services

50
Q

HIPAA

A

Health Insurance Portability and Accountability Act

51
Q

HIV

A

Human Immunodeficiency Virus

52
Q

IB

A

Investigator Brochure

53
Q

ICD

A

Informed Consent Document

54
Q

ICFs

A

Informed Consent Forms

55
Q

ICH

A

International Conference of Harmonisation

56
Q

IDE

A

Investigational Device Exemption

57
Q

IEC

A

Independent Ethics Committee

58
Q

IND

A

Investigational New Drug

59
Q

IP

A

Intellectual Property

60
Q

iPSC

A

Induced Pluripotent Stem Cells

61
Q

IRB

A

Institutional Review Board

62
Q

IV

A

Intravenous

63
Q

LAR

A

Legally Authorized Representative

64
Q

LCD

A

Local Coverage Determination

65
Q

MDUFA

A

Medical Device User Fee and Modernization Act

66
Q

MOHFW

A

Ministry of Health & Family Welfare

67
Q

MRI

A

Magnetic Resonance Imaging

68
Q

MTP

A

Medical Termination of Pregnancy

69
Q

NABH

A

National Accreditation Board for Hospitals and Health Care Providers

70
Q

NAI

A

No action Indicated

71
Q

NCD

A

National Coverage Determination

72
Q

NCI

A

National Cancer Institute

73
Q

NDA

A

New Drug Application

74
Q

NGSCR

A

National Guidelines for Stem Cell Research

75
Q

NIDPOE

A

Notice of Initiation of Disqualification Proceedings and Opportunity to Explain

76
Q

NIH

A

National Institutes of Health

77
Q

NSR

A

NonSignificant Risk

78
Q

OAI

A

Official Action Indicated

79
Q

OCP

A

Office of Combination Products

80
Q

OCR

A

Office for Civil Rights

81
Q

OHRP

A

Office of Human Research Protection

82
Q

OIG

A

Office of the Inspector General

83
Q

PHI

A

Protected Health Information

84
Q

PHS

A

Public Health Service

85
Q

PI

A

Principle Investigator

86
Q

PIS

A

Patient Information Sheet

87
Q

PMA

A

Premarket Approval

88
Q

PMOA

A

Primary Mode of Action

89
Q

QA

A

Quality Assurance

90
Q

QC

A

Quality Control

91
Q

RA

A

Rheumatoid Arthritis

92
Q

RBM

A

Risk-Based Monitoring

93
Q

RCA

A

Root Cause Analysis

94
Q

SADR

A

Serious Adverse Drug Reactions

95
Q

SAEs

A

Serious Adverse Events

96
Q

SE

A

Schedule of Events

97
Q

SOC

A

Standard of Care

98
Q

SOP

A

Standard Operating Procedure

99
Q

SR

A

Significant Risk

100
Q

SSC

A

Somatic Stem Cells

101
Q

URL

A

Uniform Resource Locator

102
Q

VAI

A

Voluntary Action Indicated

103
Q

WHO

A

World Health Organization

Clinical Research (1 decks)

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