SOCRA 2024 Annual Conference Program Book - Flipbook - Page 77
TERMINOLOGY
356 h (FDA Form) Application to Market a New Drug,
Biologic or an Antibiotic Drug for Human Use
1571 (FDA Form) Investigational New Drug
Application
1572 (FDA Form) - Statement of Investigator
3454 (FDA Form) Certification: Financial Interest and
Arrangements of Clinical Investigators
482 (FDA Form) - Notice of Inspection
483 (FDA Form) - Inspectional Observations
484 (FDA Form) - Receipt for Samples
510(k) 3 Premarket Notification Submission
ADE - Adverse Drug Event
ADR 3 Adverse Drug Reaction
AE 3 Adverse Event
AERS 3 Adverse Events Reporting System
AIP 3 Application Integrity Policy
ALCOA 3 A = Attributable; L = Legible; C =
Contemporaneous; O = Original, A = Accurate
ANDA 3 Abbreviated New Drug Application
ANPR - Advanced Notice of Proposed Rulemaking
BA 3 Bioavailability
BE 3 Bioequivalence
BIMO - Bioresearch Monitoring (FDA)
BLA 3 Biologics License Application
BPR- Basic Physiological Research (Devices)
caAERS 3 Cancer Adverse Event Reporting System
CAPA 3 Corrective and Preventive Action
CBER - (FDA) Center for Biologics Evaluation and
Research
CDASH 3 Clinical Data Acquisition Standards
Harmonization
CDER - (FDA) Center for Drug Evaluation and
Research
CDRH - (FDA) Center for Devices and Radiological
Health
CFR - Code of Federal Regulations (U.S.)
CFSAN 3 (FDA) Center for Food Safety and Applied
Nutrition
cGCP 3 Current Good Clinical Practices
cGMP 3 Current Good Manufacturing Practices
CI 3 Clinical Investigator
Clinical Trial - 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
CPGM 3 Compliance Program Guidance Manual
CRA - Clinical Research Associate (may be with
sponsor or site)
CRC 3 Clinical Research Coordinator
CRF - Case Report Form / Case Record Form
CRO 3 Contract Research Organization
CS - Clinically Significant
CSO 3 (FDA) Consumer Safety Officer
CTMS 3 Clinical Trials Management System
CV - Curriculum Vitae
CVM 3 Center for Veterinary Medicine
DBM 3 Division of Bioresearch Monitoring (CDRH)
DDMAC 3 Division of Drug Marketing, Advertising and
Communication
DHHS 3 Department of Health and Human Services
Division 5 - Section of TPD regulations relating to
clinical Trials
DMAIC 3 Define, Measure, Analyze, Improve, Control
(Six Sigma Project Management)
DO 3 (FDA) District Office
DQ 3 Disqualification
DSI 3 Division of Scientific Investigations (CDER)
DSMB 3 Data Safety Monitoring Board
DSMC 3 Data Safety Monitoring Committee
DSMICA 3 Division of Small Manufacturers,
International and Consumer Assistance CDRH
HER 3 Electronic Health Record
EI 3 (FDA) Establishment Inspection
EIR 3 (FDA) Establishment Inspection Report
EMEA 3 European Medicines Evaluation Agency
(European Union)
EOP1 - End of Phase 1
EOP2 3 End of Phase 2
FD&C Act 3 Federal Food, Drug, and Cosmetic Act (the
Act)
FDA - Food and Drug Administration
FDAAA 3 Food and Drug Administration Amendment
Acts of 2007
FDAMA 3 Food and Drug Administration
Modernization Act (1997)
FOI 3 Freedom of Information
FOIA 3 Freedom of Information Act
FR 3 Federal Register
FY 3 Fiscal Year (October 1 3 September 30)
GCP 3 Good Clinical Practice
- 77 -
