Abbreviations Flashcards
1
Q
IRB
A
Institutional Review Board
2
Q
NCI
A
National Cancer Institute
3
Q
FDA
A
Federal Drug Administration
4
Q
OHRP
A
Office of Human Research Protections
5
Q
AE
A
Adverse event
6
Q
SAE
A
Severe adverse event
7
Q
ADR
A
Adverse drug reaction
8
Q
CRO
A
Contract Research Organization
9
Q
SMO
A
Site Management Organization
10
Q
GCP
A
Good Clinical Practice
11
Q
CRA
A
Clinical research associate
12
Q
CRF
A
Case report form
13
Q
PI
A
Principal investigator
14
Q
ICH
A
International Council on Harmonisation
15
Q
CFR
A
Code of federal regulations
16
Q
IND
A
Investigational New Drug Application
17
Q
NIH
A
National Institutes of Health
18
Q
SOP
A
Standard Operating Procedure
19
Q
CRC
A
Clinical research coordinator
20
Q
DSMB
A
Data and Safety Monitoring Board
21
Q
DSMC
A
Data and Safety Monitoring Committee
22
Q
ICF
A
Informed consent form
23
Q
IDE
A
Investigational Device Exemption
24
Q
FWA
A
Federalwide Assurance
25
CV
Curriculum Vitae
26
GLP
Good laboratory practice
27
GMP
Good manufacturing practice
28
HIPAA
Health insurance portability and accountability act
29
IEC
Independent ethics committee
30
NDA
New drug application
31
PK
Pharmacokinetics
32
PD
Pharmacodynamics
33
PMA
Pre-market appreoval
34
PHI
Protected Health Information
35
IB
Investigator brochure
36
IDB
Investigator drug brochure
37
LAR
Legally authorized representative
38
DOD
Department of defense
39
QA
Quality assurance
40
QC
Quality control
41
CBER
Center for biologics evaluation and research
42
FDAAA
Federal drug administration amendments act
