Clinical Trials Acronyms & Abbreviations

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)

DAEN - Database of Adverse Event Notifications – medicines or devices

DCF - Data Correction Form

DCT - Decentralised Clinical Trial

DLT - Dose Limiting Toxicity

DM - Data Manager

DMP - Data Management Plan

DOA - Delegation of Authority

DSMC(B) - Data Safety Monitoring Committee (or Board)

DSUR - Development Safety Update Report

EC - Ethics Committee

eCOA - Electronic Clinical Outcome Assessments

eCRF - Electronic Case Report Form

eSource - Electronic Source Data

ED - Essential Documents

EDC - Electronic Data Capture

EMA - European Medicines Agency

EMR - Electronic Medical Record

EOS - End of Study

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

FPI - First Patient In (recruited to a trial)

FPFV - First Patient First Visit

GCDMP - Good Clinical Data Management Practice

GCP - Good Clinical Practice

GDP - Good Documentation Practice

GDRP - General Data Protection Regulation

GLNR - Greater than Low Risk

GLP - Good Laboratory Practice

GMO - Genetically Modified Organism

GMP - Good Manufacturing Practice

GVP - Good Pharmacovigilance Practice

HCP - Health Care Provider

HIPAA - Health Insurance Portability and Accountability Act

HREA - Human Research Ethics Application

HREC - Human Research Ethics Committee

IB - Investigator's Brochure

ICF - Informed Consent Form

ICH -  International Conference on Harmonization

IDMC - Independent Data Monitoring Committee

IIT - Investigator Initiated Trials

IP - Investigational Product

IMD - Investigational Medicinal Device

IMP - Investigational Medicinal Product

IMV - Interim Monitoring Visit

IND - Investigational New Drug

IVRS - Interactive Voice Recognition System

IRB - Institutional Review Board

ISF - Investigator Site File

LHD - Local Health District

LNR - Low and Negligible Risk

LOI - Letter of Intent

LPLV - Last Patient Last Visit

MD - Medical Device

MMP - Medical Monitoring Plan

MP - Monitoring Plan

MTA - Material Transfer Agreement

NCTGF - National Clinical Trials Governance Framework

NDA - New Drug Application

NIH - National Institutes of Health (US)

NMA - National Mutual Acceptance

NHMRC - National Health and Medical Research Council

OGTR - Office of Gene Technology Regulator

PHA - Public Health Act

PHI -  Protected Health Information

PHO - Public Health Organisation

PI - Principal Investigator

PICF - Patient Information Sheet and Consent Form

PIS - Patient Information Sheet

PK - Pharmacokinetic

PD - Pharmacodynamic

PSQV - Pre-Study Qualification Visit

PV - Pharmacovigilance (Safety)

QA - Quality Assurance

QC - Quality Control

QMS - Quality Management System

QOL - Quality of Life

QRM - Quality Risk Management

RA - Research Associate

RCA - Root Cause Analysis

RCT - Randomised controlled trial

RBM - Risk Based Monitoring

REGIS - Research Ethics and Governance Information System (NSW & ACT)

RGO - Research Governance Office

RWD(E) - Real World Data (or Evidence)

SADE - Serious Adverse Device Effect

SAE - Serious Adverse Effect

SAR - Serious Adverse Reaction

SaMD - Software as a Medical Device

SC - Study Coordinator

SDTM - Study Data Tabulation Model (statistics standard)

SDV - Source Document Verification

SIV - Site Initiation Visit

SMP - Safety Monitoring Plan

SOA - Schedule of Assessments

SOC - Standard of Care

SOP - Standard Operating Procedure

SQV - Site Qualification Visit

Sub-I - Sub Investigator

SSI - Significant Safety Issue

SSU - Study Start Up

SSV - Site Selection Visit

SMF - Site Master File

SOP - Standard Operating Procedure

SSA (STE) - Site Specific Assessment (Research Governance application)

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

USADE - Unanticipated Serious Adverse Device Effect

UADR - Unexpected Adverse Drug Reaction

USM - Urgent Safety Measure

WHO - World Health Organization