Clinical Research Acronyms and Abbreviations You Should Know
We all know there are numerous acronyms and abbreviations used in clinical research. While some can be easily deciphered, others may take some searching to find their meaning. Particularly with the recent surge in electronic systems and regulations, it can be hard to keep track of necessary abbreviations and terms.
Whether you’re new to the clinical research world or need a refresher, here’s a condensed list of common acronyms and abbreviations you may come across.
AACI: Association of American Cancer Institutes
AAHRPP: Association for the Accreditation of Human Research Protection Programs
ABSA: Association of Biosafety and Biosecurity
ACRP: Association of Clinical Research Professionals
ACTS: Association for Clinical and Translational Science
ADME: Absorption, Distribution, Metabolism, and Elimination
ADR: Adverse Drug Reaction
AE: Adverse Event
ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
AMC: Academic Medical Center
API: Active Pharmaceutical Ingredient
API: Application Program Interface
ARO: Academic Research Organization
ASCO: American Society of Clinical Oncology
ASCPT: American Society for Clinical Pharmacology and Therapeutics
ASGCT: American Society of Gene & Cell Therapy
BA/BE: Bioavailability/Bioequivalance
BLA: Biological Licensing Application
BSM: Biospecimen Management
caBIG: Cancer Biomedical
CAPA: Corrective and Preventive Action
CAR-T: Chimeric Antigen Receptors and T cells
CBER: Center for Biologics Evaluation and Research
CBRN: California Board of Registered Nursing
CCEA: Complete, Consistent, Enduring, Available
CCOP: Community Clinical Oncology Program
CCR: Center for Cancer Research
CCSG: Cancer Center Support Grant
CCTO or CTO: Centralized Clinical Trials Office or Clinical Trials Office
CDASH: Clinical Data Acquisition Standards Harmonization
CDER: Center for Drug Evaluation and Research
CDM: Clinical Data Management
Related article: “Improve Data Quality with 5 Fundamentals of Clinical Data Management”
CDP: Clinical Development Plan
CDRH: Center for Devices and Radiological Health
CDS: Clinical Data System
CDUS: Clinical Data Update System
CFR: Code of Federal Regulations
CMO: Contract Manufacturing Organization
CMS: Centers for Medicare & Medicaid Services
CRA: Clinical Research Associate
CRC: Clinical Research Coordinator
Related article: “Deciphering the CRC Career Path: Key Skills and Responsibilities”
CRF: Case Report Form
CRMS: Clinical Research Management System
CRO: Contract Research Organization
CRPC: Clinical Research Process Content
CSO: Contract Safety Organization
CSR: Clinical Study Report
CTA: Clinical Trial Authorization
CTCAE: Common Terminology Criteria for Adverse Events
CTMS: Clinical Trial Management System
CTRP: Clinical Trials Reporting Program
CTSA: Clinical and Translational Science Award
DDI: Drug-Drug Interaction
DHHS: Department of Health and Human Services
DM: Data Manager
DMC: Data Monitoring Committee
DSMB: Data and Safety Monitoring Board
EC: Ethics Committee
eCOA: Electronic Clinical Outcome Assessment
eCRF: Electronic Case Report Form
EDC: Electronic Data Capture
Learn more about Advarra’s electronic data capture system, Advarra EDC.
EHR: Electronic Health Record
EMR: Electronic Medical Record
ePRO: Electronic Patient-Reported Outcomes
eTMF: Electronic Trial Master File
FAIR: Findable, Accessible, Interoperable, Reusable
FDA: Food and Drug Administration
FE: Food Effect
FIH: First In Human
FWA: Federalwide Assurance
GCRC: General Clinical Research Center
GDP: Good Documentation Practice
GLP: Good Laboratory Practice
GMP: Good Manufacturing Practice
GVP: Good Pharmacovigilance Practice
HIPAA: Health Insurance Portability and Accountability Act
HRPP: Human Research Protection Program
IBC: Institutional Biosafety Committee
ICF: Informed Consent Form
ICH: International Council for Harmonization
IDE: Investigational Device Exemptions
IEC: Independent Ethics Committee
IHCRA: In House Clinical Research Associate
IIT: Investigator Initiated Trial
IND: Investigational New Drug (Application)
IP: Investigational Product
IRB: Institutional Review Board
ITT: Intent to Treat
IVRS: Interactive Voice Response System
IWRS: Interactive Web Response System
LTFU: Long Term Follow Up
LRAA: Local Regulatory Affairs Associate
MAC: Medicare Administrative Contractor
MAD: Multiple Ascending Dose
MCA: Medicare Coverage Analysis
Related webinar: Build a Better Budget: Using Medicare Coverage Analysis to Streamline Study Startup.
MRN: Medical Record Number
NCI: National Cancer Institute
NDA: New Drug Application
NHV: Normal Healthy Volunteer
NIH: National Institutes of Health
NLM: National Library of Medicine
OCT: Office of Clinical Trials
OHRP: Office for Human Research Protections
OSR: Outside Safety Report
PAC: Post Approval Commitments
PC: Protocol Coordinator
PD: Protocol Director
PHI: Protected Health Information
PI: Principal Investigator
PK/PD: Pharmacokinetic/Pharmacodynamic
PRE: Prompt Reporting Event
PRMC: Protocol Review and Monitoring Committee
PRMS: Protocol Review and Monitoring System
QC: Quality Control
QCT: Qualifying Clinical Trial
QMS: Quality Management System
SAD: Single Ascending Dose
SAE: Serious Adverse Event
SC: Study Coordinator
SDR: Source Document Review (Also Source Data Review)
SDTM: Study Data Tabulation Model
SDV: Source Document Verification
SIF: Site Investigator File
SMO: Site Management Organization
SOC: Standard of Care
SOE: Schedule of Events
SOP: Standard Operating Procedure
Related article: “Data Collection in Clinical Trials: 4 Steps for Creating an SOP”
SPOREs: Specialized Programs for Research Excellence
SRB: Scientific Review Board
SRC: Scientific Review Committee
SUSAR: Suspected Unexpected Serious Adverse Reaction
SVT: Subject Visit Template
TMF: Trial Master File (also eTMF)
TMO: Trial Management Organization
UADE: Unanticipated Adverse Device Effect
UADR: Unexpected Adverse Drug Reaction
UAP: Unanticipated Problem
Is there an abbreviation or acronym you see regularly in clinical research that isn’t listed here? Let us know.
To learn more about the fundamentals of clinical research, check out these free resources:
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