As one of our patients memorably put it clinical trials can feel like an ‘orgy of acronyms’ — or, to put it more politely, an overwhelming tangle of letters and shorthand.
This glossary explains common terms used in cancer research and clinical trials across Australia and New Zealand. It’s designed to make trial information easier to follow and empower you to take part in conversations about research and care.
A
Adverse Event (AE)
Any unwanted medical occurrence during a trial, whether or not it’s related to the treatment.
C
Case Report Form (CRF)
The record used by study staff to collect all data for each participant.
Contract Research Organisation (CRO)
A company contracted to manage parts of a trial such as data collection or monitoring.
Clinical Trial (CT)
A research study testing new ways to prevent, detect or treat disease.
Common Terminology Criteria for Adverse Events (CTAE / CTCAE)
The standard system for grading side-effects in cancer trials.
Sydney Clinical Trials Centre, University of Sydney (Sydney)
A major Australian academic trials centre partnering with groups like TOGA.
Clinical Trial Centre Management (CTCMS)
The database used to track trial operations, ethics, sites and documents.
Clinical Trials Group (CTG)
A not-for-profit collaborative network (e.g. TOGA) that designs and conducts academic trials.
Clinical Trial Notification (CTN)
The TGA process that allows approved trials to commence in Australia.
Clinical Trial Centre Management (CTCMS)
The database used to track trial operations, ethics, sites and documents.
Clinical Trials Research Agreement (CTRA)
The legal contract between sponsor and site covering responsibilities, insurance and payment.
Complete Pathological Response (CPR)
No viable cancer cells found after treatment (usually surgery).
Material Transfer Agreement (CTRA Addendum (MTA))
Governs transfer of human tissue or samples between institutions.
Trial Management Committee (CTRC / TMC)
Oversees daily trial operations and decision-making.
Clinical Quality Registry (CQR)
Collects outcome data to monitor and improve standards of care outside formal trials.
D
Database lock
The point when data entry and cleaning are complete and the dataset is “locked” for statistical analysis.
Data management
The systematic collection, cleaning and storage of trial data to ensure accuracy, consistency and confidentiality.
Disease-Free Survival (DFS)
The time after treatment during which no cancer is detected.
Data Safety Monitoring Board / Independent Data Monitoring Committee (DSMB / IDMSC / SDMC)
Independent experts who review safety and efficacy data during a trial.
E
Expanded Access Program (EAP)
Allows access to an investigational drug outside a formal trial (also called compassionate use or Special Access Scheme (SAS)).
Event-Free Survival (EFS)
The time from trial enrolment until disease progression, recurrence, or another defined event such as withdrawal or death.
European Thoracic Oncology Platform (ETOP)
An international research network TOGA often collaborates with.
F
US Food and Drug Administration (FDA)
Regulates medicines and clinical trials in the United States.
First Patient In (FPI)
Date the first participant provides consent and is enrolled in the trial.
First Patient First Visit (FPFV)
Date the first participant receives their first dose or study intervention.
G
Good Clinical Practice (GCP)
International ethical and scientific quality standard for designing and running trials.
Good Manufacturing Practice (GMP)
Quality standards ensuring medicines are consistently produced and controlled.
H
Human Research Ethics Committee (AUS/NZ) / Institutional Review Board (US) (HREC / IRB)
Reviews research for participant safety and ethics.
Health-Related Quality of Life / Quality of Life (HRQoL / QoL)
Patient-reported measure of wellbeing used as a secondary or exploratory endpoint.
Health Technology Assessment (HTA)
Evaluates clinical and cost-effectiveness to inform public funding decisions.
Hypothesis
The specific statement a trial is designed to test (e.g. “Drug A will improve survival compared with standard care”).
I
Investigator’s Brochure (IB)
Summary of all known information about the trial drug or treatment, provided to investigators.
Investigational Medicinal Product (IMP)
The new drug or therapy being tested in a trial.
IND / CTN / CTX
Regulatory pathways that permit investigational products to be used in trials (Australia uses CTN or CTX schemes).
Intention-to-Treat / Per-Protocol analysis (ITT / PP)
Two main approaches to analysing trial data.
L
Last Patient In (LPI)
Date the final participant is enrolled.
Last Patient First Visit (LPFV)
When the last participant receives their first study treatment.
Last Patient Last Visit (LPLV)
Completion date of the final participant’s final visit; marks the end of data collection.
M
Medicare Benefits Schedule (MBS)
Australia’s list of subsidised medical services, relevant when trial procedures are billed.
MedSafe
New Zealand’s medicines and medical-devices regulator.
Monitoring
Regular on-site or remote review of trial conduct and data by monitors or CROs to ensure participant safety, data accuracy and compliance with GCP and the protocol.
Material Transfer Agreement (MTA)
Legal document governing the transfer of biological materials between organisations.
O
Objective Response Rate (ORR)
The proportion of patients with tumour shrinkage (partial + complete responses).
Overall Survival (OS)
The time from enrolment or diagnosis until death from any cause.
P
Pharmaceutical Benefits Advisory Committee (PBAC)
Evaluates evidence to decide if a drug should be subsidised on the PBS.
Pharmaceutical Benefits Scheme (PBS)
Australia’s subsidised medicines program.
Progression-Free Survival (PFS)
The time during which cancer does not grow or spread.
Pharmac
New Zealand’s agency that decides which medicines are publicly funded.
Population, Intervention, Comparator, Outcome (PICO)
Framework for structuring a research.
Participant Information and Consent Form / Statement (PICF / PIS)
Explains a trial and records that a participant understands and agrees.
Patient-Reported Outcomes / Measures / Experience Measures (PRO / PROMs / PREMs)
Data directly from participants about symptoms, quality of life or care experience.
Protocol
The detailed plan describing a trial’s aims, design and conduct.
Q
Quality-Adjusted Life Year (QALY)
Combines quality and length of life to assess treatment value; often used in HTA.
R
Research Electronic Data Capture (REDCap)
Secure web-based platform for building and managing trial databases and eCRFs; widely used in academic research.
S
Serious Adverse Event (SAE)
An event that results in hospitalisation, disability or death.
Statistical Analysis Plan (SAP)
Outlines how trial data will be analysed.
Source Data Verification (SDV)
Process of checking trial data against original source records (e.g. patient notes) to ensure accuracy and completeness.
Site Initiation Visit (SIV)
Meeting to train site staff before recruitment begins.
Site
A hospital or clinic approved to recruit participants and deliver the trial treatment.
Source data
The original record of clinical observations and measurements (e.g. hospital charts, lab reports, scan results) from which trial data are derived.
Start-up
The early phase of trial preparation, including contracts, ethics and governance approvals, budgeting and site set-up.
Suspected Unexpected Serious Adverse Reaction (SUSAR)
A serious and unanticipated side-effect of a study drug.
T
Therapeutic Goods Administration (TGA)
Australia’s regulator for medicines, devices and clinical trials.
Trial Master File (TMF)
The central record of all essential trial documents.
Trial Management / Steering Committee (TMC / TSC)
Groups guiding operational and strategic decisions.
