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CRA Study Guide > Acronyms > Flashcards

Acronyms Flashcards

1
Q

PQV

A

Pre Qualification Visit

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2
Q

PSSV

A

Pre-Site Selection Visit

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3
Q

QSV

A

Qualification Site Visit

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4
Q

SIV

A

Site Initiation Visit

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5
Q

IMV

A

Interim Monitoring Visit

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6
Q

RMV

A

Routine Monitoring Visit

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7
Q

IRB

A

Institutional Review Board

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8
Q

EC

A

Ethics Committee

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9
Q

CDA

A

Confidential Disclosure Agreement

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10
Q

PI

A

Principal Investigator

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11
Q

Sub-I/Co-I

A

Sub-Investigator/Co-Investigator

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12
Q

CRC

A

Clinical Research Coordinator

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13
Q

AE

A

Adverse Event

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14
Q

ALCOAC

A

Attributable, Legible, Contemporaneous, Original, Accurate, Complete

Standard in which data must be entered in a clinical trial.

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15
Q

AML

A

Acute Myeloid Leukemia

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16
Q

CAPA

A

Corrective and Preventive Action

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17
Q

CDA

A

Confidential Disclosure Agreement

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18
Q

CFR

A

Code of Federal Regulations

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19
Q

CLL

A

Chronic Lymphocytic Leukemia

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20
Q

COL

A

Clinical Operation Lead

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21
Q

COV

A

Close-Out Visit

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22
Q

CMP

A

Clinical Monitoring Plan

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23
Q

CRA

A

Clinical Research Associate

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24
Q

CRO

A

Contract Research Organization

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25
Q

CS

A

Clinically Significant

PI decision for abnormal lab values

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26
Q

CRF

A

Case Report Form

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27
Q

CTCAE

A

Common Terminology Criteria in Adverse Events

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28
Q

CTM

A

Clinical Trial Manager

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29
Q

CTMS

A

Clinical Trial Management System

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30
Q

CV

A

Resume

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31
Q

DCF

A

Data Correction/Change Form

Form to update data entered incorrectly

32
Q

DOA Log

A

Delegation of Authority Log

33
Q

DM

A

Data Manager

34
Q

DMC

A

Data Monitoring Committee

35
Q

DSMB

A

Data and Safety Monitoring Board

36
Q

eCRF

A

Electronic Case Report Form

37
Q

EDC

A

Electronic Data Capture

38
Q

ECOG

A

Eastern Cooperative Oncology Group

39
Q

EHR

A

Electronic Health Record

40
Q

EMR

A

Electronic Medical Record

41
Q

ePRO

A

Electronic Patient-Reported Outcomes

Electronic devices used to compete patient questionnaires. Supplied to sites by Sponsors

42
Q

eTMF

A

Electronic Trial Master File

43
Q

FDA

A

Food and Drug Administration

44
Q

FDF

A

Financial Disclosure Form

45
Q

FIH

A

First-In Human

46
Q

FWA

A

Federal-Wide Assurance

Documentation of an institution (IRB) commitment to comply with federal regulations

47
Q

GCP

A

Good Clinical Practice

48
Q

HIPAA

A

Health Insurance Portability and Accountability Act

49
Q

ICF

A

Informed Consent Form

50
Q

ICH-GCP

A

International Council for Harmonization-Good Clinical Practice

51
Q

IEC

A

Independent Ethics Committee

52
Q

IND

A

Investigational New Drug

53
Q

IB

A

Investigator Brochure

54
Q

IP

A

Investigational Product

55
Q

ISL

A

Investigator Safety Letter

56
Q

ISF

A

Investigator Site File

57
Q

IVRS

A

Interactive Voice Response System

58
Q

IWRS

A

Interactive Web Response System

59
Q

LCRA

A

Lead Clinical Research Associate

60
Q

LM

A

Line Manager

61
Q

LTFU

A

Long Term Follow up

62
Q

ML

A

Medical License

63
Q

MRN

A

Medical Record Number

64
Q

NCI

A

National Cancer Institute

65
Q

NCS

A

Not Clinically Significant

PI decision for abnormal lab values

66
Q

NDA

A

New Drug Application

67
Q

NTF

A

Note to File

68
Q

PD

A

Protocol Deviation

Pharmacodynamic
The body’s response to the drug

69
Q

PI

A

Principal Investigator

70
Q

PK

A

Pharmacokinetics

Blood drawn to determine the movement of a drug w/in the body which usually have specific time points.

71
Q

PM

A

Project Manager

72
Q

PSP

A

Protocol Signature Page

73
Q

PSV

A

Pre Study Visit

74
Q

RECIST

A

Response Evaluation Criteria in Solid Tumors

75
Q

SAE

A

Serious Adverse Event

CRA Study Guide (6 decks)

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