Acronyms Flashcards

1
Q

PQV

A

Pre Qualification Visit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

PSSV

A

Pre-Site Selection Visit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

QSV

A

Qualification Site Visit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

SIV

A

Site Initiation Visit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

IMV

A

Interim Monitoring Visit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

RMV

A

Routine Monitoring Visit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

IRB

A

Institutional Review Board

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

EC

A

Ethics Committee

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

CDA

A

Confidential Disclosure Agreement

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

PI

A

Principal Investigator

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Sub-I/Co-I

A

Sub-Investigator/Co-Investigator

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

CRC

A

Clinical Research Coordinator

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

AE

A

Adverse Event

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

ALCOAC

A

Attributable, Legible, Contemporaneous, Original, Accurate, Complete

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

AML

A

Acute Myeloid Leukemia

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

CAPA

A

Corrective and Preventive Action

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

CDA

A

Confidential Disclosure Agreement

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

CFR

A

Code of Federal Regulations

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

CLL

A

Chronic Lymphocytic Leukemia

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

COL

A

Clinical Operation Lead

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

COV

A

Close-Out Visit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

CMP

A

Clinical Monitoring Plan

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

CRA

A

Clinical Research Associate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

CRO

A

Contract Research Organization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
CS
Clinically Significant PI decision for abnormal lab values
26
CRF
Case Report Form
27
CTCAE
Common Terminology Criteria in Adverse Events
28
CTM
Clinical Trial Manager
29
CTMS
Clinical Trial Management System
30
CV
Resume
31
DCF
Data Correction/Change Form Form to update data entered incorrectly
32
DOA Log
Delegation of Authority Log
33
DM
Data Manager
34
DMC
Data Monitoring Committee
35
DSMB
Data and Safety Monitoring Board
36
eCRF
Electronic Case Report Form
37
EDC
Electronic Data Capture
38
ECOG
Eastern Cooperative Oncology Group
39
EHR
Electronic Health Record
40
EMR
Electronic Medical Record
41
ePRO
Electronic Patient-Reported Outcomes Electronic devices used to compete patient questionnaires. Supplied to sites by Sponsors
42
eTMF
Electronic Trial Master File
43
FDA
Food and Drug Administration
44
FDF
Financial Disclosure Form
45
FIH
First-In Human
46
FWA
Federal-Wide Assurance Documentation of an institution (IRB) commitment to comply with federal regulations
47
GCP
Good Clinical Practice
48
HIPAA
Health Insurance Portability and Accountability Act
49
ICF
Informed Consent Form
50
ICH-GCP
International Council for Harmonization-Good Clinical Practice
51
IEC
Independent Ethics Committee
52
IND
Investigational New Drug
53
IB
Investigator Brochure
54
IP
Investigational Product
55
ISL
Investigator Safety Letter
56
ISF
Investigator Site File
57
IVRS
Interactive Voice Response System
58
IWRS
Interactive Web Response System
59
LCRA
Lead Clinical Research Associate
60
LM
Line Manager
61
LTFU
Long Term Follow up
62
ML
Medical License
63
MRN
Medical Record Number
64
NCI
National Cancer Institute
65
NCS
Not Clinically Significant PI decision for abnormal lab values
66
NDA
New Drug Application
67
NTF
Note to File
68
PD
Protocol Deviation Pharmacodynamic The body’s response to the drug
69
PI
Principal Investigator
70
PK
Pharmacokinetics Blood drawn to determine the movement of a drug w/in the body which usually have specific time points.
71
PM
Project Manager
72
PSP
Protocol Signature Page
73
PSV
Pre Study Visit
74
RECIST
Response Evaluation Criteria in Solid Tumors
75
SAE
Serious Adverse Event