Access request review 

Access request review is a mechanism used by Public Health Organisations to ensure that the proposed research project complies with minimum governance requirements, and to consider whether to support the provision of access to participants, their tissue or data through the Public Health Organisation as requested by the project.

Biobank

A biobank is a secure place for storing human samples. Like a bank, samples donated for health and medical research are kept under tight security and in carefully controlled conditions.

Biostatistician

An expert in the field if statistics that deals with data relating to living organisms.

Case report form (CRF)

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the Sponsor on each trial participant. In almost all cooperative and commercial trials, this is an electronic version, e.g. an eCRF.

Certificate of Currency

Important insurance details are recorded in a Certificate of Currency, including the types of liabilities covered and any monetary limit for a single event. Both institutions and investigator are often required to disclose specific details of insurance cover preceding acceptance of involvement in many clinical trials.

Clinical trial

Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.

Clinical Trial Approval (CTA) scheme 

The TGA must be notified by the sponsor of their intent to supply ‘unapproved’ therapeutic goods in a clinical trial. The CTA scheme is generally designed for high-risk or novel treatments where there is no or limited knowledge of safety. For medical device trials, the CTA scheme may be more appropriate where the experimental device introduces new technology, new material or a new treatment concept which has not been evaluated previously in clinical trials in any country. The CTA scheme should also be considered for medical devices that pose a risk of serious patient harm.

Clinical Trial Notification (CTN) scheme

The TGA must be notified of any clinical trial involving an ‘unapproved’ therapeutic good by the Sponsor. This must take place before starting to use the goods.

Clinical trial sub-contract

A legally binding agreement that manages the relationship between the primary site and the satellite site where the satellite site is a separate legally entity to the primary site.

Collaborator

An individual or organisation other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

Confidentiality and non-disclosure agreement (CDA, NDA)

A legal contract that is used to allow the sharing of sensitive information between two parties. It generally includes why the parties are sharing information but does not specify the information itself

Consumer

Patients and potential patients, carers and people who use health care services.

Clinical Trial Management System

A specialised software system used to manage clinical trials operations and to store operational data to support planning, performing and reporting functions, along with participant information, tracking deadlines and milestones.

Clinical Trial Research Agreement (CTRA)

A legally binding written agreement clarifying the obligations, responsibilities and rights of the parties involved in the trial. The agreement covers matters such as confidentiality, intellectual property, ownership of data, insurance and indemnity.

Clinical Investigation Research Agreement (CIRA)

A legally binding written agreement clarifying the obligations, responsibilities and rights of the parties involved in a trial using devices. The agreement covers matters such as confidentiality, intellectual property, ownership of data, insurance and indemnity.

Co-ordinating Principal Investigator

The individual who takes overall responsibility for the research project and submits the project for ethical and scientific review. They are responsible for ongoing communication with the HREC and passing on any outcomes from this to the Principal Investigators. For single centre research, Coordinating Investigator and Principal Investigator are synonymous.

Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee

A multidisciplinary group established by the trial Sponsor to review, at intervals, accumulating trial data, to monitor the progress of a trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons. These are most often mandated to be independent of the Sponsor by the HREC approving the study (e.g. iDSMC)

Delegation log

Each study requires a delegation log that specifies study staff members and the duties delegated to them by the principal investigator for the duration of their involvement with the study.

Early Phase Clinical Trials

Early Phase Clinical Trial definition includes all clinical trial phases up to but not including Phase II, including studies with any Phase I component.

Essential documents

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, Sponsor and monitor with the standards of GCP and with all applicable regulatory requirements. They may be subject to, and should be available for, audit by the Sponsor’s auditor and inspection by the regulatory authority/ies. Essential documents for the trial should be supplemented or may be reduced where justified (in advance of study initiation) based on the importance and relevance of the specific documents to the study.

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. ICH GCP E6 (R2) is an internationally accepted standards for the designing, conducting, recording and reporting of clinical trials/clinical investigations.

Human Research Ethics Committee (HREC)

A committee constituted in accordance with the National Statement on Ethical Conduct in Human Research (2007) to review and where appropriate approve and monitor the ethical and scientific aspects of human research.

Indemnity

An indemnity is a promise by one party to another that it will cover a loss arising from an event that happens to the other party.

Informed consent

A process by which a participant voluntarily confirms their willingness to participate in a particular trial, after having been informed of and understanding all aspects of the trial that are relevant to the participant’s decision to participate. Informed consent is documented using a written, signed and dated informed consent form.

Inspection

The act by a regulatory authority/ies of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority/ies to be related to the clinical trial and that may be located at the site of the trial, at the Sponsor’s and/or contract research organisation’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority/ies.

Insurance

A policy taken out by an individual or individual organisation to cover their liabilities

International Council for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Conceived in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.

Investigational product (IP or investigational medical product, IMP)

Any therapeutic good (including placebos) being tested or used as a reference in a clinical trial.

Investigator

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.

Investigator Site File

A compilation of essential documents maintained at the site that assist in the successful management of a trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the sponsor’s independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected. Refer to Section 8 of the ICH E6 (R2) Good Clinical Practice for further guidance and a list of essential documents.

Memorandum of Understanding (MOU)

A non-legal binding document that may be used to reflect the researchers (and/or their organisation) intent to collaborate with another researcher/ organisation through co-operation, sharing information, knowledge and/ or skills.

National Health and Medical Research Council (NHMRC)

The council established to develop and maintain health standards and is responsible for implementing the National Health and Medical Research Council Act 1992.

Participant

A person recruited to participate in the Study.

Participant information and consent form (PICF)

The ethically approved document used for providing written patient information about a specific clinical trial and the documentation of informed consent in the form of the patient and the investigator signatures and date.

Peer review

Refers to the assessment of research or researchers by others working in the same or a related field. Peer review methods are used to maintain quality standards, improve performance, and provide credibility.

Principal investigator

The person responsible, individually or a leader of the researchers at a site, for the conduct of a trial at that site. Where the Australasian Tele-Trial Model is implemented, the principal investigator at the primary site assumes overall responsibility and provides oversight to satellite site/s within a cluster.

Protocol

A document that describes the objective/s, design, methodology, statistical considerations, and organisation of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP guideline the term protocol refers to protocol and protocol amendments.

Note: Known as a clinical investigation plan for medical devices studies 

Site

The place/s where the clinical trial is conducted.

Randomisation

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

Registration

The process of submitting and updating summary information about a clinical study and its protocol, from its beginning to end, to a structured, public Web-based study registry that is accessible to the public, such as the Australian Clinical Trials Registry

Regulatory Authority

Any body which has jurisdiction over the conduct of the study at the study site and includes the TGA and any overseas regulatory authorities who may audit, or require to be audited, any part of the clinical Trial or Trial Materials.

Research Office

The office within an NSW Public Health Organisation that is appointed to oversee and support research.

Site authorisation

The authorisation granted by the Chief Executive or delegate of the NSW PHO for the commencement of a research project.

Source documents

Original documents (where the data was first recorded), data, and records (for example medical/hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).The principles apply to all records referenced irrespective of the type of media used.

Sponsor

A trial sponsor is an individual (e.g. Medical practitioner) or organisation (e.g. hospital, university, non-government organisation, cooperative research group) that take responsibility for the initiation, management, provision of insurance and indemnity, and/or financing of a clinical trial. The trial sponsor carries the medico-legal responsibility for the trial’s conduct and is also responsible for:

• The quality and integrity of the clinical trial data.
• Ensuring that appropriate approvals and authorisations are met and adhered to during the clinical trial.
• Monitoring the trial for compliance with the protocol.

Standard Operating Procedures (SOPs)

A set of step by step instructions to assist sites to conduct trial activities in accordance with Good Clinical Practice (GCP) and any relevant local and national requirements. The SOPs help to ensure sites achieve the dual requirements of GCP to protect the rights, safety, and wellbeing of participants; and to ensure the reliability of trial data.

Study Coordinator

A research worker who works at a clinical research site under the immediate direction of a principal investigator, whose research activities are conducted in accordance with GCP guidelines. May also be called ‘Clinical Study Coordinator’, ‘Trial Coordinator’, ‘Research Coordinator’ or ‘Research Nurse’. Where a teletrials model is engaged, the study coordinator at the primary site is the contact for coordinators at both primary and satellite sites. Their duties are extended to include satellite sites in all aspects of their role (these roles can be delegated to satellite site coordinators).

Trial Master File

A compilation of all essential documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. Refer to Section 8 of the ICH E6 (R2) Good Clinical Practice for further guidance and a list of essential documents.