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Glossary of Important Terms Related to Clinical Trials

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Location Settings

Asia-Pacific

AU -  Sydney
AU -  Melbourne
AU -  Brisbane
CN -  Hong Kong
CN -  Shanghai
IN -  Bangalore
MY -  Kuala Lumpur
PH -  Metro Manila
KR -  Seoul
CN -  Taipei City
TH -  Bangkok
NZ -  New Zealand

North America

US -  San Francisco
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English

The following list are common terms that are often associated with clinical research and trials.

Adverse Event (AE): A negative change or medical event that occurs during a clinical trial, or soon afterwards. It may or may not be caused by the treatment received in the trial.

Allocation: A method used to assign participants to an arm of a clinical study. (Includes random and non-random allocation).

Arm: A group or subgroup of participants in a clinical trial who either receive treatment or no intervention at all, according to the trial’s protocol.

Arm Type: Identifies the intervention that participants receive.

Background Therapy: The current medication/treatment that is taken for a particular disease or condition.

Baseline: The time point in a clinical trial that provides the basis for assessing any changes. Various tests are carried out at this time.

Blinding: One or more of the groups involved in the trial (participant or researchers) have no knowledge of what treatments have been assigned to particular participants.

Clinical Study/Trial: Research which uses human volunteers (participants) and are aimed at evaluating a medical, surgical or behavioural intervention. The most effective way for researchers and medical professionals to find out if a particular new treatment or medication is safe and effective to use.

Clinical Trial Exemption (CTX): An approval process. The Therapeutic Goods Administration (TGA) directly reviews the planned clinical trial and must give their approval for the clinical trial to go ahead.

Clinical Trial Notification (CTN): A notification process. The Human Research Ethics Committee (HREC) reviews the scientific and ethical nature of the proposed clinical trial. The Therapeutic Goods Administration (TGA) is also notified about the clinical trial.

Control: The standard (control) treatment is compared against the experimental treatment. It shows that the already approved treatment works and is an easy way to find out if the experimental treatment is effective at all.

Consent Form: The written document which is signed by the participant, showing that they give informed consent (permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits).

Cross-Over Trial: Where groups of participants are given two or more interventions in a specific order (one group will receive ‘Drug A’ at the beginning of the trial and then switch to ‘Drug B’, while another group will be given ‘Drug B’ first and then ‘Drug A’. All the participants will be given both drugs during the trial.

Data Management: The process of gathering, using and storing the personal information given by participants, and any documentation gathered during the clinical trials.

Dosing Discontinuation: When a participant stops taking a study drug for any reason (this can occur during or after the clinical trial).

Double-Blind: When neither the participants or the researchers know what drugs or treatments the participants are receiving. This eliminates any biases.

Early Patient Withdrawal: When a participant pulls out of a clinical trial before its completion (due to various factors).

Efficacy: An indication that the experimental medication or treatment produces a desired result during the clinical trial.

Eligibility Criteria: The requirements that participants must meet before taking part in a clinical trial. It includes both inclusion and exclusion criteria.

Good Clinical Practice (GCP): An International scientific quality and ethical standard with regards to conduct, design, monitoring, performance, recording, auditing, analysis and reporting of clinical studies.

Health Authority: National and international health agencies that authorises and regulates a clinical trial.

Human Research Ethics Committee (HREC): A regulatory body which reviews all research proposals to ensure that they are ethically responsible.

Informed Consent: When permission to take part in a clinical study is granted by a participant who has full knowledge of the possible risks and benefits they might face.

Intervention: A medication or treatment that is tested for clinical research purposes.

Investigational Drug: The experimental drug which is being evaluated in the clinical trial.

Masking: When one or more groups taking part in the clinical trial don’t know what experimental treatments the participants have been assigned. Includes both single and double-blind masking.

Medication Number: A unique number on each experimental medication package which is used to track medication dosages.

National Health and Medical Research Council (NHMRC): A statutory authority and the main Australian agency who is responsible for medical and public health research. They fund high quality health and medical research to increase research capability and encourage the translation of research into better health outcomes. They also promote the highest ethical standards for health and medical research.

Observational Study: Assesses health outcomes of participants in their everyday lives, while they are assigned the experimental treatment as part of their regular medical care.

Open Label Trial: When participants and researchers know what medication or treatment is being administered.

Outcome Measure: A set measurement which is outlined in the clinical trial protocol and is used to evaluate the effect an experimental drug or treatment has on a participant.

Phases: Used to describe the different stages of a clinical trial which is based on the number of participants, the objective of the study, the dosage of medication given, and the length of the study. There are generally 4 phases in a clinical trial.

Placebo: A sugar or inactive pill which is used in clinical trials to test the effectiveness of an experimental drug.

Protocol: A detailed plan/guide of the clinical trial which outlines the objectives, design, methodology, ethical issues, and organisation of a trial.

Quality Assurance (QA): Ensures that all the data is generated, recorded, and reported in compliance with Good Clinical Practice (GCP) standards.

Quality Control (QC): Ensures that the internal operations of the clinical trial are all performed within the quality assurance system to verify that the requirements have been fulfilled. (form checks, monitoring, reports, etc).

Randomization: Assigning participants to different control groups or treatments by random chance.

Regulatory Authority: A public authority or government agency which exercises complete control over an industry in a regulatory or supervisory capacity, especially when the products within that sector can pose a high risk to the public.

Research: When a study is carried out to answer a question or find a solution.

Screening Process: A process which evaluates whether people are eligible to take part in the clinical trial. Various tests will be carried out and the person will be asked about their personal and family medical history.

Serious Adverse Event: An adverse event that is serious or life threatening. It may or may not be a result of the clinical trial.

Single-Blind Research Design: When either the researchers or participants don’t know what treatment or medication they’re being given in the clinical trial.

Standard Treatment: The treatment that is considered to be the most effective and readily available at the time of the clinical trial.

Subject Number: A unique number which is given to each participant in the clinical trial to keep track of their progress or any issues that may arise.

Therapeutic Goods Administration (TGA): A regulatory authority which is part of the Australian Government Department of Health. It was established in 1989 under the Therapeutic Goods Act 1989, and ensures that all therapeutic products meet the acceptable standards of quality and safety. Unmasking/Unblinding: When the participants and the researchers are made aware of what treatment(s) the participants have been receiving.