Afkortingen

Question 1

ABR

Answer 1

Algemeen beoordelings- en registratieformulier

Question 2

ADE

Answer 2

Adverse Device Effect

Question 3

AE

Answer 3

Adverse Event

Question 4

AVG

Answer 4

Algemene verordening gegevensbescherming

Question 5

BAI

Answer 5

Besluit actieve implantaten

Question 6

BCB

Answer 6

Besluit centrale beoordeling medisch-wetenschappelijk
onderzoek met mensen

Question 7

BI

Answer 7

Bevoegde Instantie

Question 8

BMH

Answer 8

Besluit medische hulpmiddelen

Question 9

BROK

Answer 9

Basiscursus Regelgeving en Organisatie voor Klinisch
onderzoekers

Question 10

BW

Answer 10

Burgelijk Wetboek

Question 11

CAPA

Answer 11

Corrective and preventive action

Question 12

CBG

Answer 12

College ter Beoordeling van Geneesmiddelen

Question 13

CCMO

Answer 13

Centrale Commissie Mensgebonden Onderzoek

Question 14

CE

Answer 14

Conformitée Européenne

Question 15

CIP

Answer 15

Clinical investigational plan

Question 16

CRO

Answer 16

Contract Research Organization

Question 17

CSB

Answer 17

Centrum-specifieke bijeenkomst

Question 18

CTD

Answer 18

Clinical Trials Directive

Question 19

CV

Answer 19

Curriculum vitae

Question 20

DCRF

Answer 20

Dutch Clinicial Research Foundation

Question 21

DMP

Answer 21

Datamanagementplan

Question 22

DMS

Answer 22

Data Management System

Question 23

DPIA

Answer 23

Data Protection Impact Assessment

Question 24

DSMB

Answer 24

Data and Safety Monitoring Board

Question 25

DTA

Answer 25

Data transfer agreement

Question 26

(e)CRF

Answer 26

(elektronisch) Case Report Form

Question 27

ECTR

Answer 27

European Clinical Trials Regulation

Question 28

EDC

Answer 28

Electronic data capture

Question 29

EMA

Answer 29

European Medicines Agency

Question 30

EPD

Answer 30

Elektronisch patiëntendossier

Question 31

EU

Answer 31

Europese Unie

Question 32

FDA

Answer 32

Food and Drug Administration

Question 33

GCP

Answer 33

Good Clinical Practice

Question 34

GMP

Answer 34

Good Manufacturing Practice

Question 35

GGO

Answer 35

Genetisch gemodificeerde organismen

Question 36

HACCP

Answer 36

Hazard Analysis and Critical Control Points

Question 37

IB

Answer 37

Investigator's Brochure

Question 38

IC

Answer 38

Informed consent

Question 39

ICF

Answer 39

Informed consent formulier

Question 40

ICH GCP E6(R2)

Answer 40

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

Question 41

ICMJE

Answer 41

De internationale organisatie voor editors van medische publicaties

Question 42

IGJ

Answer 42

Inspectie gezondheidszorg en jeugd

Question 43

IMD

Answer 43

Investigational Medical Device

Question 44

IMDD

Answer 44

Investiational Medical Device Dossier

Question 45

IMP

Answer 45

Investigational Medicinal Product

Question 46

IMPD

Answer 46

Investigational Medicinal Product Dossier

Question 47

IRB

Answer 47

Institutional review board

Question 48

ISF

Answer 48

Investigator site file

Question 49

IVDR

Answer 49

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

Question 50

Lareb

Answer 50

Landelijke Registratie en Evaluatie van Bijwerkingen - Nederlands Bijwerkingen Centrum

Question 51

MDCG

Answer 51

Medical Device Coordination Grouup

Question 52

MDR

Answer 52

Medical Devices Regulation; regulation (EU) 2017/745

Question 53

MEDDEV

Answer 53

Medical devices vigilance system

Question 54

METC

Answer 54

Medisch ethische toetsingscommissie

Question 55

NDA

Answer 55

Non-disclosuere agreement

Question 56

NFU

Answer 56

Nederlandse Federatie van Universitair Medische Centra

Question 57

nIMP

Answer 57

non Investigational Medicinal Product

Question 58

NB

Answer 58

Notified body

Question 59

PI

Answer 59

Principal investigator

Question 60

PIF

Answer 60

Proefpersonen-informatieformulier

Question 61

PMCF

Answer 61

Post-market clinical follow-up

Question 62

RCT

Answer 62

Randomized clinical trials

Question 63

RET

Answer 63

Richtlijn externe toetsing

Question 64

RIVM

Answer 64

Rijksinstituut voor volksgezondheid en milieu

Question 65

RvB

Answer 65

Raad van Bestuur

Question 66

SAE

Answer 66

Serious adverse event

Question 67

SAR

Answer 67

Serious adverse reaction

Question 68

SDR

Answer 68

Source data review

Question 69

SDV

Answer 69

Source data verification

Question 70

SmPC

Answer 70

Summary of product characteristics

Question 71

SOP

Answer 71

Standard operating procedure

Question 72

SSF

Answer 72

Site specific file

Question 73

STZ

Answer 73

Samenwerkende topklinische opleidingsziekenhuizen

Question 74

SUSAR

Answer 74

Suspected unexpected serious adverse reaction

Question 75

TMF

Answer 75

Trial master file

Question 76

ToL

Answer 76

ToetsingOnline

Question 77

umc

Answer 77

Universitair medisch centrum

Question 78

USADE

Answer 78

Unanticipated Serious Adverse Device Effect

Question 79

VWS

Answer 79

Ministerie van Volksgezondheid, Welzijn en Sport

Question 80

WBO

Answer 80

Wet op het bevolkingsonderzoek

Question 81

Wet BIG

Answer 81

Wet beroepen in de individuele gezondheidszorg

Question 82

WGBO

Answer 82

Wet op de geneeskundige behandelingsovereenkomst

Question 83

Wkkgz

Answer 83

Wet kwaliteit, klachten en geschillen zorg

Question 84

WMA

Answer 84

World Medical Association

Question 85

WMH

Answer 85

Wet op medische hulpmiddelen

Question 86

WMO

Answer 86

Wet medisch-wetenschappelijk onderzoek met mensen