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