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English coaching | Flashcards > 95 Clinical Research Acronyms > Flashcards

95 Clinical Research Acronyms Flashcards

Practice most common terms used Clinical Research teams.

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Proverbs and Idioms flashcards
1
Q

ADR

A

ADVERSE DRUG REACTION

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2
Q

ADR

A

ADVERSE EVENT

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3
Q

ALCOA

A

ATTRIBUTABLE, LEGIBLE, CONTEMPORANEOUS, ORIGINAL, ACCURATE

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4
Q

API

A

ACTIVE PHARMACEUTICAL INGREDIENT/APPLICATION PROGRAM INTERFACE (IT)

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5
Q

ARO

A

ACADEMIC RESEARCH ORGANIZATION

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6
Q

BA/BE

A

BIOAVAILABILITY/BIOEQUIVALENCE

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7
Q

BLA

A

BIOLOGICAL LICENSING APPLICATION

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8
Q

BSM

A

BIOSPECIMEN MANAGEMENT

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9
Q

CA

A

COMPETENT AUTHORITY

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10
Q

CAPA

A

CORRECTIVE AND PREVENTATIVE ACTION

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11
Q

CCEA

A

COMPLETE, CONSISTENT, ENDURING, AVAILABLE

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12
Q

CCTO/CTO

A

CENTRALISED CLINICAL TRIALS OFFICES/CLINICAL TRIALS OFFICE

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13
Q

CDM

A

CLINCAL DATA MANAGEMENT

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14
Q

CDP

A

CLINICAL DEVELOPMENT PLAN

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15
Q

CDS

A

CLINICAL DATA SYSTEM

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16
Q

CDUS

A

CLINICAL DATA UPDATE SYSTEM

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17
Q

CI

A

CONFIDENCE INTERVAL

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18
Q

CMO

A

CONTRACT MANUGACTURING ORGANIZATION

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19
Q

CNT

A

CONSENTED BUT NOT TREATED

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20
Q

CPM

A

CLINICAL PROJECT
MANAGER

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21
Q

CRA

A

CLINICAL RESEARCH ASSOCIATE

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22
Q

CRC

A

CLINICAL RESEARCH COORDINATOR

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23
Q

CRF

A

CASE REPORT FORM

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24
Q

CRO

A

CLINICAL RESEARCH ORGANISATION/ CONTRACT RESEARCH ORGANISATION

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25
Q

CSR

A

CLINICAL STUDY REPORT

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26
Q

CSO

A

CONTRACT SAFETY ORGANISATION

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27
Q

CTA

A

CLINICAL TRIAL AUTHORISATION/AGREEMENT

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28
Q

CTCAE

A

COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS

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29
Q

CTMS

A

CLINICAL TRIAL MANAGEMENT SYSTEM

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30
Q

CTRP

A

CLINICAL TRIALS REPORTING PROGRAMS

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31
Q

DDI

A

DRUG-DRUG INTERACTION

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32
Q

DM

A

DATA MANAGER

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33
Q

DMC

A

DATA MONITORING COMMITTEE

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34
Q

DMP

A

DATA MANAGEMENT PLAN

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35
Q

DSMB

A

DATA SAFETY MONITORING BOARD

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36
Q

EC

A

ETHICS COMMITTEE

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37
Q

eCOA

A

ELECTRONIC CLINICAL OUTCOME ASSESMENT

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38
Q

eCRF

A

ELECTRONIC CASE REPORT FORM

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39
Q

EDC

A

ELECTRONIC DATA CAPTURE

40
Q

EHR

A

ELECTRONIC DATA CAPTURE

41
Q

EMR

A

ELECTRONIC MEDICAL RECORD

42
Q

eTMF

A

ELECTRONIC TRIAL MASTER FILE

43
Q

FAIR

A

FINDABLE, ACCESSIBLE, INTEROPERABLE, REUSABLE

44
Q

FDA

A

FOOD AND DRUG ADMINISTRATION

45
Q

FIH

A

FIRST IN HUMAN

46
Q

GCP

A

GOOD CLINICAL PRACTICE

47
Q

GDPR

A

GENERAL DATA PROTECTION REGULATION

48
Q

GLP

A

GOOD LABORATORY PRACTICE

49
Q

GMP

A

GOOD MANUFACTURING PRACTICE

50
Q

GVP

A

GOOD PHARMACOVIGILANCE PRACTICE

51
Q

ICF

A

INFORMED CONSENT FORM

52
Q

IDE

A

INVESTIGATIONAL DEVICE EXEMPTIONS

53
Q

IEC

A

INDEPENDENT ETHICS COMMITTEEI

54
Q

IHCRA

A

IN HOUSE CLINICAL TRIAL ASSOCIATE

55
Q

IMP

A

INVESTIGATIONAL MEDICAL PRODUCT

56
Q

IMPD

A

INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (EUDRA)

57
Q

IND

A

INVESTIGATIONAL NEW DRUG APPLICATION (US FDA)

58
Q

IRB

A

INSTITUTIONAL REVIEW BOARD

59
Q

IP

A

INVESTIGATIONAL PRODUCT

60
Q

ITT

A

INTENT TO TREAT

61
Q

LTFU

A

LONG TERM FOLLOW UP

62
Q

MAA

A

MARKETING AUTHORISATION APPLICATION (EUDRA)

63
Q

MAD

A

MULTIPLE ASCENDING DOSE

64
Q

MRN

A

MEDICAL RECORD NUMBER

65
Q

MP

A

MONITORING PLAN

66
Q

NDA

A

NEW DRUG APPLICATION (US FDA)

67
Q

NHV

A

NORMAL HEALTHY VOLUNTEER

68
Q

OSR

A

OUTSIDE SAFETY REPORT

69
Q

PC

A

PROTOCOL COORDINATOR

70
Q

PHI

A

PROTECTED HEALTH INFORMATION

71
Q

PD

A

PROTOCOL DIRECTOR

72
Q

PI

A

PRINCIPAL INVESTIGATOR

73
Q

PRMS

A

PROTOCOL REVIEW AND MONITORING SYSTEM

74
Q

PRO

A

PATIENT-REPORTED OUTCOMES

75
Q

QC

A

QUALITY CONTROL

76
Q

QCT

A

QAULIFYING CLINICAL TRIAL

77
Q

QMS

A

QUALITY MANAGEMENT SYSTEM

78
Q

QOL

A

QUALITY OF LIFE

79
Q

RBM

A

RISK-BASED MONITORING

80
Q

REC

A

RESEARH ETHICS COMMITTEE

81
Q

SAD

A

SINGLE ASCENDING DOSE

82
Q

SAE

A

SERIOUS ADVERSE EVENT

83
Q

SAP

A

STATISTICAL ANALYSIS PLAN

84
Q

SC

A

STUDY COORDINATOR

85
Q

SDV

A

SOURCE DOCUMENT (DATA) VERIFICATION

86
Q

SIF

A

SITE INVESTIGATOR FILE

87
Q

SOC

A

STANDARD OF CARE

88
Q

SOE

A

SHEDULE OF EVENTS

89
Q

SOP

A

STANDARD OPERATIING PROCEDURES

90
Q

SRB

A

SCIENTIFIC REVIEW BOARD

91
Q

SUSAR

A

SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION

92
Q

TMF

A

TRIAL MASTER FILE

93
Q

TMO

A

TRIAL MANAGEMENT ORGANISATION

94
Q

UADE

A

UNANTICIPATED ADVERSE DEVICE EFFECT

95
Q

UADR

A

UNEXPECTED ADVERSE DRUG REACTION

English coaching | Flashcards (17 decks)

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