When we talk to people who are new to our industry, one of the toughest things for them to wrap their heads around is the clinical trial acronyms we use.
Life science professionals use a multitude of clinical trial abbreviations, and we often rattle off a sentence packed with esoteric acronyms that we assume our listeners will be familiar with. Here is a question that came up on a call recently:
“Does GDPR contradict the FDA’s stance on remote SDV and CRFs stored in the cloud?”
Now, most people could probably tell you who the FDA is, but if you ask a layperson about SDV and CRFs and how they fit into ICH-GCP under GDPR jurisdictions, you might as well be speaking Klingon.
To help, we’ve developed a list of clinical trial acronyms that we use frequently in order to make sure new hires are able to decipher the letters we throw around. If you’re new to the industry or just need to lookup an obscure clinical acronym, we hope this helps.
Clinical Trials and Medical Terminology
ACA: Affordable Care Act
ADaM: Analysis Data Model
ADR: Adverse Drug Reaction
AE: Adverse Event
ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
AMC: Academic Medical Center
ARO: Academic Research Organization
CCEA: Complete, Consistent, Enduring, Available
CDASH: Clinical Data Acquisition Standards Harmonization
CDISC: The Clinical Data Interchange Standards Consortium
CDS: Clinical Data System
CMO: Contract Manufacturing Organization
COA: Clinical Outcome Assessments
CRA: Clinical Research Associate
CRC: Clinical Research Coordinator
CRF: Case Report Form (less frequently: Change Request Form)
CRO: Contract Research Organization
CSDD: Center for the Study of Drug Development
CSO: Contract Safety Organization
CTMS: Clinical Trial Management System
CVM: Center for Veterinary Medicine
DDC: Direct Data Capture
DM: Data Manager
DSMB: Data and Safety Monitoring Board
eCOA: Electronic Clinical Outcome Assessments
eCRF: Electronic Case Report Form
ePRO: Electronic Patient-Reported Outcome
EHR: Electronic Health Record
eICD: Electronic Consent Document
EMR: Electronic Medical Record
eSource: Electronic Source Data
eTMF: Electronic Trial Master File
FDA: Food and Drug Administration
FIH: First in Human
FPI: First Patient In
GCP: Good Clinical Practice
GDP: Good Documentation Practices
GDPR: General Data Protection Regulation
HHS: Department of Health and Human Services
HIPAA: The Health Insurance Portability and Accountability Act
IC: Informed Consent
ICD: Informed Consent Document
ICF: Informed Consent Form
ICH: International Council for Harmonization
IEC: Independent Ethics Committee
IIT: Investigator-Initiated Trial
IND: Investigational New Drug
IRB: Institutional Review Board
MD: Doctor of Medicine
MDR: Medical Devices Regulation (EMA)
NBE: New Biopharmaceutical Entity
NCE: New Chemical Entities
NDA: New Drug Application
NIH: National Institutes of Health
OCT: Office of Clinical Trials
OHRP: Office for Human Research Protections (Overseen by the Department of Health and Human Services)
PCR: Pending Changes Report
PDUFA: Prescription Drug User Fee Act
PHI: Protected Health Information
PII: Personally Identifiable Information
Pl: Principal Investigator
RTSM: Randomization and Trial Supply Management
SAE: Serious Adverse Event
SDTM: Study Data Tabulation Model
SDV: Source Document Verification
SOP: Standard Operating Procedure
tSDV: Targeted Source Document Verification
TMF: Trial Master File
General Software Terms
API: Application Program Interface (also: Active Pharmaceutical Ingredient)
CSV:Comma-Separated Values
GUI: Graphical User Interface
IRT: Interactive Response Technology
IVR: Interactive Voice Response
ODM: Operational Data Model
SaaS: Software as a Service solutions
SAS: Statistical Analysis System
SPSS: Statistical Package for the Social Sciences
TFS: Team Foundation Server
UAT: User Acceptance Testing