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CCRP Terminology, Abbreviations & Acronyms
CCRP Terminology, Abbreviations & Acronyms
170
Medical
06/30/2011

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Term
Term
Definition
Definition
Term
1571 (FDA Form)
Definition
lnvestigational New Drug Application
Term
1572 (FDA Form)
Definition
Statement of Investigator
Term
3454 (FDA Form)
Definition
Certification: Financial Interest and Arrangements of Clinical Investigators
Term
356 h (FDA Form)
Definition
Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use
Term
482 (FDA Form)
Definition
Notice of Inspection
Term
483 (FDA Form)
Definition
lnspectional Observations
Term
484 (FDA Form)
Definition
Receipt for Samples
Term
510(k)
Definition
Premarket Notification Submission
Term
ADE
Definition
Adverse Drug Event
Term
ADR
Definition
Adverse Drug Reaction
Term
AE
Definition
Adverse Event
Term
AERS
Definition
Adverse Events Reporting System
Term
AIP
Definition
Application Integrity Policy
Term
ALCOA
Definition
A = Attributable; L = Legible; C = Contemporaneous; O = Original, A = Accurate
Term
ANDA
Definition
Abbreviated New Drug Application
Term
ANPR
Definition
Advanced Notice of Proposed Rulemaking
Term
BA
Definition
Bioavailability
Term
BE
Definition
Bioequivalence
Term
BIMO
Definition
Bioresearch Monitoring (FDA)
Term
BLA
Definition
Biologics License Application
Term
BPR
Definition
Basic Physiological Research (Devices)
Term
caAERS
Definition
Cancer Adverse Event Reporting System
Term
CAPA
Definition
Corrective and Preventive Action
Term
CBER
Definition
(FDA) Center for Biologics Evaluation and Research
Term
CDASH
Definition
Clinical Data Acquisition Standards Harmonization
Term
CDER
Definition
(FDA) Center for Drug Evaluation and Research
Term
CDRH
Definition
(FDA) Center for Devices and Radiological Health
Term
CFR
Definition
Code of Federal Regulations (U.S.)
Term
CFSAN
Definition
(FDA) Center for Food Safety and Applied Nutrition
Term
cGCP
Definition
Current Good Clinical Practices
Term
cGMP
Definition
Current Good Manufacturing Practices
Term
CI
Definition
Clinical Investigator
Term
Clinical Trial
Definition
Any experiment or research study in which a drug or treatment is given to one or more human subjects to determine the safety and / or effectiveness of the drug or treatment
Term
CPGM
Definition
Compliance Program Guidance Manual
Term
CRA
Definition
Clinical Research Associate (may be with sponsor or site)
Term
CRC
Definition
Clinical Research Coordinator
Term
CRF
Definition
Case Report Form / Case Record Form
Term
CRO
Definition
Contract Research Organization
Term
CS
Definition
Clinically Significant
Term
CSO
Definition
(FDA) Consumer Safety Officer
Term
CTMS
Definition
Clinical Trials Management System
Term
CV
Definition
Curriculum Vitae
Term
CVM
Definition
Center for Veterinary Medicine
Term
DBM
Definition
Division of Bioresearch Monitoring (CDRH)
Term
DDMAC
Definition
Division of Drug Marketing, Advertising and Communication
Term
DHHS
Definition
Department of Health and Human Services
Term
Division 5
Definition
Section of TPD regulations relating to clinical Trials
Term
DMAIC
Definition
Define, Measure, Analyze, lmprove, Control (Six Sigma Project Management)
Term
DO
Definition
(FDA) District Office
Term
DQ
Definition
Disqualification
Term
DSI
Definition
Division of Scientific Investigations (CDER)
Term
DSMB
Definition
Data Safety Monitoring Board
Term
DSMC
Definition
Data Safety Monitoring Committee
Term
DSMICA
Definition
Division of Small Manufacturers, international and Consumer Assistance CDRH
Term
EHR
Definition
Electronic Health Record
Term
EIR
Definition
(FDA) Establishment Inspection Report
Term
El
Definition
(FDA) Establishment Inspection
Term
EMEA
Definition
European Medicines Evaluation Agency (European Union)
Term
EOP1
Definition
End of Phase 1
Term
EOP2
Definition
End of Phase 2
Term
FD&C Act
Definition
Federal Food, Drug, and Cosmetic Act (the Act)
Term
FDA
Definition
Food and Drug Administration
Term
FDAAA
Definition
Food and Drug Administration Amendment Acts of 2007
Term
FDAMA
Definition
Food and Drug Administration Modernization Act (1997)
Term
FOIA
Definition
Freedom of Information Act
Term
FOl
Definition
Freedom of Information
Term
FR
Definition
Federal Register
Term
FY
Definition
Fiscal Year (October 1 - September 30)
Term
GCP
Definition
Good Clinical Practice
Term
GCPP
Definition
Good Clinical Practices Program (in Office of the FDA Commissioner)
Term
GGP
Definition
Good Guidance Practices
Term
GLP
Definition
Good Laboratory Practice
Term
GMP
Definition
Good Manufacturing Practice (see QSR below)
Term
HDE
Definition
Humanitarian Device Exemption
Term
HF
Definition
Routing code for mail to the Office of the Commissioner of the FDA
Term
HFD
Definition
Routing code for mail to CDER
Term
HFM
Definition
Routing code for mail to CBER
Term
HFS
Definition
Routing code for mail to CFSAN
Term
HFV
Definition
Routing code for mail to CVM
Term
HFZ
Definition
Routing code for mail to CDRH
Term
HIPAA
Definition
Health Insurance Portability and Accountability Act
Term
HlE
Definition
Health Information Exchange
Term
HQ
Definition
Headquarters
Term
HSP
Definition
Human Subject Protection
Term
HUD
Definition
Humanitarian Use Device
Term
IB
Definition
Investigator Brochure
Term
IC
Definition
informed Consent
Term
ICD
Definition
informed Consent Document
Term
ICF
Definition
Informed Consent Form
Term
ICH
Definition
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Term
ICMJE
Definition
International Committee of Medical Journal Editors
Term
IDB / IB
Definition
lnvestigational Drug Brochure / Investigator Brochure
Term
IDE
Definition
lnvestigational Device Exemption
Term
IEC
Definition
Independent Ethics Committee
Term
IG
Definition
(Office of the) Inspector General
Term
INAD
Definition
lnvestigational New Animal Drug
Term
IND
Definition
lnvestigational New Drug (Application)
Term
IRB
Definition
institutional Review Board
Term
IRC
Definition
Institutional Review Committee
Term
ISO
Definition
International Organization for Standardization
Term
IT
Definition
Information Technology
Term
IVD
Definition
in Vitro Diagnostic
Term
lC/ lCF/ ICD
Definition
Informed Consent / Informed Consent Form / informed Consent Document
Term
IRC
Definition
Institutional Review Committee
Term
MDR
Definition
Medical Device Report (part of MedWatch)
Term
MDUFMA
Definition
Medical Device User Fee and Modernization Act (2002)
Term
MedDRA
Definition
Medical Dictionary for Regulatory Activities
Term
NAI
Definition
No Action Indicated (FDA inspection classification)
Term
NCI
Definition
National Cancer Institute
Term
NCS
Definition
Not Clinically Significant
Term
NDA
Definition
New Drug Application
Term
NEJM
Definition
New England Journal of Medicine
Term
NIDPOE
Definition
Notice of Initiation of Disqualification Proceeding and Opportunity to Explain
Term
NIH
Definition
National Institutes of Health, Health and Human Services
Term
NME
Definition
New Molecular Entity
Term
NOOH
Definition
Notice of Opportunity for Hearing
Term
NSR
Definition
Non Significant Risk (Devices)
Term
OAI
Definition
Official Action Indicated (FDA inspection classification)
Term
OC
Definition
Office of Compliance or Office of the Commissioner
Term
OCC
Definition
Office of Chief Counsel
Term
OCI
Definition
Office of Criminal Investigations
Term
ODE
Definition
Office of Device Evaluation
Term
OEI
Definition
Official Establishment inventory
Term
OGC
Definition
Office of General Counsel
Term
OGD
Definition
Office of Generic Drugs
Term
OHRP
Definition
Office for Human Research Protections (Health and Human Services)
Term
OIVD
Definition
Office of In Vitro Diagnostic Device Evaluation and Safety
Term
OMP
Definition
Office of Medical Policy CDER
Term
OND
Definition
Office of New Drugs CDER
Term
ORA
Definition
(FDA) Office of Regulatory Affairs
Term
ORI
Definition
Office of Research Integrity
Term
OTC
Definition
Over the Counter
Term
OTCOM
Definition
Office of Training and Communications CDER
Term
P&A
Definition
Promotion and Advertising
Term
PDP
Definition
Product Development Protocol
Term
PDUFA
Definition
Prescription Drug User Fee Act of 1992
Term
PEB
Definition
Program Enforcement Branch
Term
Pl
Definition
Principal Investigator (in reference to Public Health Service grant recipient)
Term
PMA
Definition
Premarket Application
Term
PMA
Definition
Premarket Approval Application
Term
PMDA
Definition
Pharmaceutical and Medical Device Agency (Japan)
Term
PMN or 510(k)
Definition
Premarket Notification
Term
QA
Definition
Quality Assurance
Term
QC
Definition
Quality Control
Term
Ql
Definition
Qualified Investigator (Canada)
Term
QS
Definition
Quality System
Term
QSR
Definition
Quality System Regulation (GMP for devices)
Term
R&D
Definition
Research and Development
Term
RAPS
Definition
Regulatory Affairs Professionals Society
Term
REB
Definition
Research Ethics Board
Term
REMS
Definition
Risk Evaluation and Mitigation Strategy
Term
RIN
Definition
Regulation Identifier Number (in Unified Agenda) or Regulatory Information Number (FR Vol. 71 No. 240 75148)
Term
SADR
Definition
Suspected Adverse Drug Reaction
Term
SAE
Definition
Serious Adverse Event
Term
SBR
Definition
Small Business Representative (ORA)
Term
SIB
Definition
Special Investigations Branch (CDRH)
Term
SMO
Definition
Site Management Organization
Term
SoCRA
Definition
Society of Clinical Research Associates
Term
SOP
Definition
Written Procedures, Standard Operating Procedures
Term
SPA
Definition
Special Protocol Assessment
Term
SR
Definition
Significant Risk (Device)
Term
SSED
Definition
Summary of Safety and Effectiveness Data
Term
The Act
Definition
The Federal Food, Drug, and Cosmetic Act
Term
TPD
Definition
Therapeutic Products Directorate of Health Canada
Term
UADE
Definition
Unanticipated Adverse Device Effect
Term
UL
Definition
Untitled Letter
Term
VA
Definition
Veterans Administration
Term
VAl
Definition
Voluntaiy Action indicated (FDA inspection classification)
Term
WL
Definition
Warning Letter