Abbreviation Glossary
A glossary of frequently used abbreviations in clinical research
- ADR
- Adverse Drug Reaction
- AE
- Adverse Event
- ALCOA
- Attributable, Legible, Contemporaneous, Original, Accurate
- API
- Active Pharmaceutical Ingredient
- BfArM
- Federal Institute for Drugs and Medical Devices (Germany)
- BfS
- Federal Office for Radiation Protection (Germany)
- BLA
- Biologics License Application
- CAPA
- Corrective and Preventive Action
- CFR
- Code of Federal Regulations
- CMC
- Chemistry, Manufacturing, and Controls
- COV
- Close-Out Visit
- CRA
- Clinical Research Associate
- CRC
- Clinical Research Coordinator
- CRF
- Case Report Form
- CRO
- Contract Research Organization
- CSR
- Clinical Study Report
- CTA
- Clinical Trial Application/Authorization
- CTIMP
- Clinical Trial of an Investigational Medicinal Product
- CTIS
- Clinical Trials Information System
- CTMS
- Clinical Trial Management System
- DSMB
- Data and Safety Monitoring Board
- DSUR
- Development Safety Update Report
- EC
- European Commission
- eCOA
- Electronic Clinical Outcome Assessment
- eCRF
- Electronic Case Report Form
- EDC
- Electronic Data Capture
- EHR
- Electronic Health Record
- EMA
- European Medicines Agency
- ePRO
- Electronic Patient-Reported Outcome
- FDA
- Food and Drug Administration
- GCP
- Good Clinical Practice
- GDP
- Good Documentation Practice
- GLP
- Good Laboratory Practice
- GMP
- Good Manufacturing Practice
- GVP
- Good Pharmacovigilance Practice
- HIPAA
- Health Insurance Portability and Accountability Act
- IB
- Investigator's Brochure
- IBR
- Institutional Biosafety Review
- ICF
- Informed Consent Form
- ICH
- International Council for Harmonisation
- IEC
- Independent Ethics Committee
- IMP
- Investigational Medicinal Product
- IMV
- Interim Monitoring Visit
- IND
- Investigational New Drug application
- IRB
- Institutional Review Board
- ISF
- Investigator Site File
- ITT
- Intent-to-Treat
- LOCF
- Last Observation Carried Forward
- MHRA
- Medicines and Healthcare products Regulatory Agency
- NDA
- New Drug Application
- PD
- Pharmacodynamics
- PEI
- Paul-Ehrlich-Institut (German Federal Institute for Vaccines and Biomedicines)
- PI
- Principal Investigator
- PK
- Pharmacokinetics
- PSUR
- Periodic Safety Update Report
- QoL
- Quality of Life
- RMP
- Risk Management Plan
- RSI
- Reference Safety Information
- SAE
- Serious Adverse Event
- SAR
- Serious Adverse Reaction
- SDV
- Source Data Verification
- SIV
- Site Initiation Visit
- SMO
- Site Management Organization
- SOP
- Standard Operating Procedure
- Sub-I
- Sub-Investigator
- SUSAR
- Suspected Unexpected Serious Adverse Reaction
- TMF
- Trial Master File
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