Clinical Trials 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)

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