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

AE              Adverse Event (same as Adverse Drug Experience, Adverse Experience, Adverse Drug Reaction, Adverse Reaction)

ADE           Adverse Device Effect

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)

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

eTMF          Electronic Trial Master File

EU              European Union

EMR           Electronic Medical Records

FDA           Food and Drug Administration

GCP           Good Clinical Practice

GLP            Good Laboratory Practice

GMP           Good Manufacturing 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

IMP            Investigational Medicinal Product

IND             Investigational New Drug

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

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

SMF           Site Master File

SOP           Standard Operating Procedure

SUSAR       Serious Unexpected Suspected Adverse Reaction

TGA            Therapeutic Goods Administration

TMF            Trial Master File

WHO          World Health Organization