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Recherche clinique > Termes > Flashcards

Termes Flashcards

1
Q

SOP

A

MOD Mode Opératoire normalisé

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2
Q

Storage conditions

A

Conditions d’entreposage

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3
Q

Medical devices

A

Appareils médicaux

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4
Q

Advanced therapy medicinal products ATMP

A

Médicaments de thérapie innovante

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5
Q

IMP Investigational medical product

A

Médicaments expérimental, produit de recherche médicaments sous investigation

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6
Q

GCPClinical Clinical practice

A

BPC Bonnes pratiques cliniques

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7
Q

PI Principal investigator

A

Investigateur principal

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8
Q

EC/IRB Ethics committee institutional review board

A

CEI/CEE/CPP

Comité d’éthique indépendant /comité d’examen de l’établissement /comité de protection des personnes

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9
Q

Institution

A

Établissement

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10
Q

CDA confidentiality disclosure agreement

A

Accord de confidentialité NDA

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11
Q

ICH international Council for harmonization

A

ICHConférence internationale sur l’harmonisation

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12
Q

CRO Contract research organization

A

CRO Prestataire dans la recherche clinique, organisme de recherche sous contrat

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13
Q

TMF Trail master file

A

Dossier principal de l’essai clinique

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14
Q

Regulatory requirements

A

Exigences réglementaires

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15
Q

standard

A

Norme

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16
Q

Clinical trials subject

A

Sujet d’essai clinique

17
Q

CRA/monitor

A

ARC/surveillant

18
Q

Risk benefit.Ratio

A

Les Avantages l’emporte sur les risques

19
Q

Approval

A

Approbation opinion favorable préalable

20
Q

GDPR

A

RGDP règlement généralSur la protection des données

21
Q

CRF

A

Support de recueil des données

22
Q

Regulatory submission

A

Soumission réglementaire

Recherche clinique (2 decks)

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