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@BROK > Afkortingen > Flashcards

Afkortingen Flashcards

1
Q

ABR

A

Algemeen beoordelings- en registratieformulier

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2
Q

ADE

A

Adverse Device Effect

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3
Q

AE

A

Adverse Event

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4
Q

AVG

A

Algemene verordening gegevensbescherming

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5
Q

BAI

A

Besluit actieve implantaten

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6
Q

BCB

A

Besluit centrale beoordeling medisch-wetenschappelijk
onderzoek met mensen

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7
Q

BI

A

Bevoegde Instantie

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8
Q

BMH

A

Besluit medische hulpmiddelen

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9
Q

BROK

A

Basiscursus Regelgeving en Organisatie voor Klinisch
onderzoekers

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10
Q

BW

A

Burgelijk Wetboek

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11
Q

CAPA

A

Corrective and preventive action

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12
Q

CBG

A

College ter Beoordeling van Geneesmiddelen

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13
Q

CCMO

A

Centrale Commissie Mensgebonden Onderzoek

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14
Q

CE

A

Conformitée Européenne

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15
Q

CIP

A

Clinical investigational plan

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16
Q

CRO

A

Contract Research Organization

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17
Q

CSB

A

Centrum-specifieke bijeenkomst

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18
Q

CTD

A

Clinical Trials Directive

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19
Q

CV

A

Curriculum vitae

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20
Q

DCRF

A

Dutch Clinicial Research Foundation

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21
Q

DMP

A

Datamanagementplan

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22
Q

DMS

A

Data Management System

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23
Q

DPIA

A

Data Protection Impact Assessment

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24
Q

DSMB

A

Data and Safety Monitoring Board

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25
Q

DTA

A

Data transfer agreement

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26
Q

(e)CRF

A

(elektronisch) Case Report Form

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27
Q

ECTR

A

European Clinical Trials Regulation

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28
Q

EDC

A

Electronic data capture

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29
Q

EMA

A

European Medicines Agency

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30
Q

EPD

A

Elektronisch patiëntendossier

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31
Q

EU

A

Europese Unie

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32
Q

FDA

A

Food and Drug Administration

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33
Q

GCP

A

Good Clinical Practice

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34
Q

GMP

A

Good Manufacturing Practice

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35
Q

GGO

A

Genetisch gemodificeerde organismen

36
Q

HACCP

A

Hazard Analysis and Critical Control Points

37
Q

IB

A

Investigator’s Brochure

38
Q

IC

A

Informed consent

39
Q

ICF

A

Informed consent formulier

40
Q

ICH GCP E6(R2)

A

Richtsnoer ‘Good Clinical Practice’ van ‘The International Council
for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use’

41
Q

ICMJE

A

De internationale organisatie voor editors van medische
publicaties

42
Q

IGJ

A

Inspectie gezondheidszorg en jeugd

43
Q

IMD

A

Investigational Medical Device

44
Q

IMDD

A

Investiational Medical Device Dossier

45
Q

IMP

A

Investigational Medicinal Product

46
Q

IMPD

A

Investigational Medicinal Product Dossier

47
Q

IRB

A

Institutional review board

48
Q

ISF

A

Investigator site file

49
Q

IVDR

A

Medische hulpmiddelen voor in-vitrodiagnostiek; regulation (EU)
2017/746

50
Q

Lareb

A

Landelijke Registratie en Evaluatie van Bijwerkingen -
Nederlands Bijwerkingen Centrum

51
Q

MDCG

A

Medical Device Coordination Grouup

52
Q

MDR

A

Medical Devices Regulation; regulation (EU) 2017/745

53
Q

MEDDEV

A

Medical devices vigilance system

54
Q

METC

A

Medisch ethische toetsingscommissie

55
Q

NDA

A

Non-disclosuere agreement

56
Q

NFU

A

Nederlandse Federatie van Universitair Medische Centra

57
Q

nIMP

A

non Investigational Medicinal Product

58
Q

NB

A

Notified body

59
Q

PI

A

Principal investigator

60
Q

PIF

A

Proefpersonen-informatieformulier

61
Q

PMCF

A

Post-market clinical follow-up

62
Q

RCT

A

Randomized clinical trials

63
Q

RET

A

Richtlijn externe toetsing

64
Q

RIVM

A

Rijksinstituut voor volksgezondheid en milieu

65
Q

RvB

A

Raad van Bestuur

66
Q

SAE

A

Serious adverse event

67
Q

SAR

A

Serious adverse reaction

68
Q

SDR

A

Source data review

69
Q

SDV

A

Source data verification

70
Q

SmPC

A

Summary of product characteristics

71
Q

SOP

A

Standard operating procedure

72
Q

SSF

A

Site specific file

73
Q

STZ

A

Samenwerkende topklinische opleidingsziekenhuizen

74
Q

SUSAR

A

Suspected unexpected serious adverse reaction

75
Q

TMF

A

Trial master file

76
Q

ToL

A

ToetsingOnline

77
Q

umc

A

Universitair medisch centrum

78
Q

USADE

A

Unanticipated Serious Adverse Device Effect

79
Q

VWS

A

Ministerie van Volksgezondheid, Welzijn en Sport

80
Q

WBO

A

Wet op het bevolkingsonderzoek

81
Q

Wet BIG

A

Wet beroepen in de individuele gezondheidszorg

82
Q

WGBO

A

Wet op de geneeskundige behandelingsovereenkomst

83
Q

Wkkgz

A

Wet kwaliteit, klachten en geschillen zorg

84
Q

WMA

A

World Medical Association

85
Q

WMH

A

Wet op medische hulpmiddelen

86
Q

WMO

A

Wet medisch-wetenschappelijk onderzoek met mensen

@BROK (6 decks)

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