Clinical Trials Acronyms & Abbreviations

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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

ADaM - Analysis Data Model (statistics standard)

ADE - Adverse Device Effect

ADR - Adverse Drug Reaction

AE - Adverse Event

AI - Associate Investigator

ALCOA - Attributable, Legible, Contemporaneous, Original, Accurate

ANZCTR - Australia and New Zealand Clinical Trials Registry

AR - Adverse Reaction

ARTG - Australian Register of Therapeutic Goods

ASR - Annual Safety Report

CAP - Consumer Advisory Panel

CAPA - Corrective and Preventative Action

CDA - Confidentiality Disclosure Agreement

CDASH - Clinical Data Acquisition Standards Harmonisation (statistics standard)

CDISC - The Clinical Data Interchange Standards Consortium

CI - Chief-Investigator

CMO - Contract Manufacturing Organisation

COA - Clinical Outcome Assessments

Co-I - Co-Investigator

COV - Close-Out Visit

CPI - Coordinating Principal Investigator

CRA - Clinical Research Associate

CRC - Clinical Research Coordinator

CRF  - Case Report Form

CRO - Contract Research Organisation

CSO - Contract Safety Organisation

CRN - Clinical Research Nurse

CSR - Clinical Study Report

CT - Clinical Trial

CTA - Clinical Trial Approval (scheme) – previously Clinical Trial Exemption (CTX)

CTAC(P) - Clinical Trials Advisory Committee (or Panel)

CTC - Clinical Trial Co-ordinator

CTCAE - Common Terminology Criteria for Adverse Events

CTMS - Clinical Trial Management System

CTN - Clinical Trial Notification (Scheme)