Abbreviations Flashcards
(28 cards)
1
Q
AE
A
Adverse event
2
Q
ALCOA
A
Attributable, legible, contemporaneous, original, accurate
3
Q
CCEA
A
Complete, consistent, enduring, available
4
Q
CDM
A
Clinical data management
5
Q
eCRF
A
Electronic case report form
6
Q
CRO
A
Contract research organization
7
Q
CTCAE
A
Common terminology criteria for adverse events
8
Q
CTMS
A
Clinical trial management system
9
Q
DM
A
Data management
10
Q
EC
A
Ethics committee
11
Q
EDC
A
Electronic data capture
12
Q
EMR
A
Electronic medical record
13
Q
ePRO
A
Electronic patient reported outcomes
14
Q
GCP
A
Good clinical practice
15
Q
GDP
A
Good documentation practice
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
SDV
Source document verification
26
SI
Sub-investigator
27
SIF
Site investigator file
28
SUSAR
Suspected unexpected serious adverse reaction
