Abbreviations Flashcards

1
Q

AE

A

Adverse event

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2
Q

ALCOA

A

Attributable, legible, contemporaneous, original, accurate

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3
Q

CCEA

A

Complete, consistent, enduring, available

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4
Q

CDM

A

Clinical data management

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5
Q

eCRF

A

Electronic case report form

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6
Q

CRO

A

Contract research organization

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7
Q

CTCAE

A

Common terminology criteria for adverse events

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8
Q

CTMS

A

Clinical trial management system

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9
Q

DM

A

Data management

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10
Q

EC

A

Ethics committee

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11
Q

EDC

A

Electronic data capture

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12
Q

EMR

A

Electronic medical record

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13
Q

ePRO

A

Electronic patient reported outcomes

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14
Q

GCP

A

Good clinical practice

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15
Q

GDP

A

Good documentation practice

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16
Q

ICF

A

Informed consent form

17
Q

ICH

A

International council for harmonization

18
Q

IRB

A

Investigational review board

19
Q

ISF

A

Investigator site file

20
Q

IWRS

A

Interactive web response system

21
Q

NDA

A

New drug application

22
Q

QI

A

Qualified investigator

23
Q

SAE

A

Serious adverse event

24
Q

SC

A

Study coordinator

25
Q

SDV

A

Source document verification

26
Q

SI

A

Sub-investigator

27
Q

SIF

A

Site investigator file

28
Q

SUSAR

A

Suspected unexpected serious adverse reaction