CRA Abbreviations/ Terms Flashcards

1
Q

AE

A

Adverse Event

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2
Q

CNS

A

Central Nervous System

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3
Q

CRF

A

Case Report Forms

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4
Q

CRO

A

Clinical Research Organization/ Contract Research Organization

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5
Q

eCRF

A

Electronic Case Report Form

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6
Q

FDA

A

Food and Drug Administration

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7
Q

GCP

A

Good Clinical Practice

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8
Q

GLP

A

Good Laboratory Practice

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9
Q

ICF

A

Informed Consent Form

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10
Q

ICH

A

International Council on Harmonisation

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11
Q

IEC

A

Independent Ethics Committee

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12
Q

IND

A

Investigational New Drug

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13
Q

IRB

A

Institutional Review Board

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14
Q

MTD

A

Maximum Tolerated Dose

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15
Q

PK

A

Pharmacokinetic

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16
Q

QOL

A

Quality of Life

17
Q

RP2D

A

Recommended Phase 2 Dose

18
Q

SAE

A

Serious Adverse Event

19
Q

SUSAR

A

Suspected Unexpected Serious Adverse Reaction

20
Q

WCBP

A

Women of Childbearing Potential