Clinical Trials Acronyms & Abbreviations
While conducting clinical trials, you will encounter a multitude of acronyms and abbreviations. Here's a list of some of the more common ones.
What are Clinical Trials?
A clinical trial is a trial conducted with patients, evaluating new treatments, drugs or devices, in patients. They can also test improved procedures of treating, preventing, screening and diagnosing disease in patients.
For those who conduct clinical trials, the amount of new information can be overwhelming; acronyms, abbreviations and new terminology can be a major stumbling block for new triallists. Here, we provide some of the more common acronyms and terminology you'll encounter. This list isn't exhaustive, but should provide you with a jumping off point.
Common Acronyms
ADE Adverse Device Effect
ADR Adverse Drug Reaction
ALCOA Attributable, Legible, Contemporaneous, Original, Accurate
ANZCTR Australia and New Zealand Clinical Trials Registry
AR Annual Report
ASE Annual Safety Report
CAP Consumer Advisory Panel
CAPA Corrective and Preventative Actions
CI Co-Investigator
CRA Clinical Research Associate
CRC Clinical Research Coordinator
CRF Case Report Form
CRO Contract Research Organisation
CSO Consumer Safety Officer (FDA)
CRN Clinical Research Nurse
CSR Clinical Study Report
CTAC Clinical Trials Advisory Committee
CTC Clinical Trial Co-ordinator
CTMS Clinical Trial Management System
CTN Clinical Trial Notification (Scheme)
CTX Clinical Trial Exemption (Scheme)
DSMC Data Safety Monitoring Committee
EC Ethics Committee
eCRF Electronic Case Report Form
ED Essential Documents
EDC Electronic Data Capture
ECG: Electrocardiogram
EMR: Electronic Medical Record
ePRO: Electronic Patient-Reported Outcomes
eTMF Electronic Trial Master File
EU European Union
EMR Electronic Medical Records
FDA Food and Drug Administration
FIH First in Human
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 of 1996
HREC Human Research Ethics Committee
IB Investigator's Brochure
ICF Informed Consent Form
ICH International Conference on Harmonization
IDSMC Independent Data Safety Monitoring Committee
IIT Investigator Initiated Trials
IMP Investigational Medicinal Product
IND Investigational New Drug
IVRS Interactive Voice Recognition System
IRB Institutional Review Board
ISF Investigator Site File
IRIS Medical Device Incident Reporting and Investigation Scheme (TGA)
MD Medical Device
NDA New Drug Application
NHMRC National Health and Medical Research Centre
PI Principal Investigator
PK Pharmacokinetic
PD: Pharmacodynamic
PSQV Pre-Study Qualification Visit
QA Quality Assurance
QC Quality Control
RCA Root Cause Analysis
RBM Risk Based Monitoring
RGO Research Governance Office
SADE Serious Adverse Device Effect
SaMD Software as a Medical Device
SDV Source Document Verification
SOC Standard of Care
SQV Site Qualification Visit
SSV Site Selection Visit
SMF Site Master File
SOP Standard Operating Procedure
SSR sample size re-estimation (used in adaptive design clinical trials)
SUSAR Serious Unexpected Suspected Adverse Reaction
TGA Therapeutic Goods Administration
TLF Tables, listings and figures (used in clinical study reports)
TMF Trial Master File
Tx Treatment
UADE Unanticipated Adverse Device Effect
UADR Unexpected Adverse Drug Reaction
WHO World Health Organization