ATP definition guide

This Australian Teletrial Program definition guide (also called a glossary) defines the terms commonly used in the project. Based on the National Standard Operating Procedures, and following extensive co-design, collaboration and advice from all national stakeholders. All definitions are adapted from both Australian and International industry standards including, but not limited to; ICH GCP, NHMRC, FDA and TGA and will be reviewed every 12 months.

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ATP: Australian Teletrial Program

Associate Investigator: A qualified person designated and supervised by the Principal Investigator, responsible for conducting a clinical trial activity, and/or to make important trial related decisions, at a local coordinating site, which is geographically distant from the Principal Investigator’s Primary Site.

Australian Teletrial Program: A health systems research initiative to treat and manage diseases and conditions locally and make clinical trials for new novel drugs, technologies, and models of care accessible to regional, rural and remote communities. Currently, 88% of clinical trials are run from city or urban areas, meaning regional, rural and remote patients cannot access them unless they travel or move.
The Australian Teletrial Program uses the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) approved Australasian Teletrial Model that was piloted in 2017 and is now being scaled across six Australian jurisdictions through the Medical Research Future Fund Enabling Infrastructure Grant. Regional Clinical Trial Coordinating Centres have been established in the Northern Territory, Queensland, South Australia, Tasmania, Western Australia and Victoria.

Biomarker: A defined characteristic measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions. Biomarkers may include molecular, histologic, radiographic, or physiologic characteristics. A biomarker is not a measure of how an individual feels, functions, or survives. Categories of biomarkers include: susceptibility/risk biomarker; diagnostic biomarker; monitoring biomarker; prognostic biomarker; predictive biomarker; response biomarker; safety biomarker.

Clinical Research Coordinator - CRC: 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 Good Clinical Practice guidelines, the National Statement, and the National Clinical Trials Governance Framework. May also be called “Clinical Study Coordinator” or “Trial Coordinator” or “Research Coordinator” or “Research Nurse”. Where Teletrials are engaged, the CRC 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).

Clinical Trial (audience: - consumer): Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventative care.
Clinical trials are designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.

Clinical Trial (audience: health professional): A clinical trial is 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, preventative care, etc. This definition includes Phase I to Phase IV trials.

Clinical Trial Coordinator - CTC: As per Clinical Research Coordinator.

Clinical Trial Research -Agreement - CTRA: A head agreement between a Sponsor and Principal Investigator's Institution, used along with a sub-contract between the Primary Site and the Satellite Site under the ATM (see also Sub-contract). A legally binding document that outlines the obligations, responsibilities and rights of the parties involved in a clinical trial.

Community: A group of people sharing a common interest (e.g. cultural, social, political, health, economic interests) but not necessarily a particular geographic association. Different types of communities are likely to have different perspectives and approaches to their involvement in research.

Community member: A member of a community.

Consumer: Someone who has lived experience, or who uses or engages with the health care system. This includes patients and potential patients, carers, and people who use health care services. Collectively, ‘consumers’ and ‘community members’ may be referred to as ‘the public’.

Consumer representative: Someone who voices consumer perspectives and takes part in the decision-making process on behalf of consumers. This person may be nominated by, and may be accountable to, an organisation of consumers. This consumer representative however may have a narrower view as they are speaking on behalf of their organisation and not necessarily that of the wider community. A consumer representative may be appropriately trained or may undergo training and be supported to advocate for consumer-centred health care.

Contract Research Organisation - CRO: A person or an organisation (commercial, academic, or other) contracted by the Sponsor to perform one or more of a Sponsor's trial related duties and functions.

Coordinating Principal Investigator: Assigned the responsibility of conduct and coordination between multicentre trials including coordination of ethics, process and submissions, communication notifications on behalf the Primary and Satellite Site Investigators. Excludes the responsibility for trial activity at the site (excluding when holding the dual role of Principal Investigator). Role is not relevant for teletrials, only the relationship between Investigators within the cluster.

Decentralised trial: A trial where some or all the trial related activity occur at locations other than a traditional clinical trial site, including direct to patient at home. The Australian Teletrial Program (ATP) promotes Teletrials, a subset of Decentralised Trials (DCTs). Teletrials are a safety mechanism and quality control for DCTs, because they support sites closer to where the patient lives, improving access and availability for people living in regional, rural and remote areas. Teletrials can be part of a hybrid model, where elements of the study are conducted from the patients home. The ATP uses DCT technologies to create efficiencies within the telehealth aspect of the program, designed to reduce health inequity and improve patient outcomes. In fully decentralised trials, all activities take place outside traditional trial sites, while hybrid trials combine remote and in-person activities. Decentralised trials aim to enhance convenience for participants, reduce the burden on caregivers, expand access to diverse populations, and improve trial efficiencies. They leverage digital health technologies and telemedicine to facilitate remote participation, data collection, and monitoring, which can lead to more inclusive and efficient clinical research.

Delegation Log: A list of appropriately qualified and trained persons to whom the Principal Investigator has delegated significant study-related duties and functions. The Log details related duties and documents which study-specific roles and responsibilities are assigned to each staff member on the study team.

Digital Biomarker: Objective quantifiable physiological and behavioural data that is collected and measured through a digital device, such as a portable device, wearable, implantable or digestible.

Digital Health: The use of digital technologies to improve health outcomes, healthcare delivery, and health system efficiency. Digital health includes a wide range of technologies, such as electronic health records (EHRs), telehealth, mobile health (mHealth), health information technology (IT), wearable devices, and personalised medicine. The goal is to create a connected and digitally enabled healthcare system that places individuals at the centre, providing them with better access to their health information and improved quality of care.

Digital Health Technology: A digital health technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for health and related uses.

Health and medical research: Research with a human health focus.

Medical Device: Any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: (i) diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease; (ii)diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; (iii) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; (iv) control of support of conception; (v) in vitro examination of a specimen derived from the human body for a specific medical purpose and does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or (aa) any instrument, apparatus, appliance, software, implant, reagent, material or other article specific under subsection (2A); or (ab) any instrument, apparatus, appliance, software, implant, reagents, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or (b) an accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph (a), (aa) or (ab). (c) a system or procedure pack.

Modified Monash Model: The Modified Monash Model (MMM) is how we define whether a location is metropolitan, rural, remote or very remote. The model measures remoteness and population size on a scale of Modified Monash (MM) categories MM 1 to MM7. MM 1 is a major city, and MM7 is very remote. These classifications are based on the Australian Statistical Geography Standard Remoteness Areas framework. The MMM is reviewed following the Census every five years.

Primary Health: Primary care is health care people seek first in their community, such as GPs, pharmacies and allied health professionals, when they have a health concern. A whole-of-society approach designed to ensure the highest possible level of health and well-being and their equitable distribution by focusing on people's needs. This approach spans the continuum from health promotion and disease prevention to treatment, rehabilitation, and palliative care. It aims to provide comprehensive, integrated, and people-centred care that is close to where people live and work, thus improving accessibility and efficiency.

Primary Site: The Primary Site coordinates the trial across a Teletrial cluster to enhance participant reach, recruitment and management. The Principal Investigator located at the Primary Site has full responsibility for conducting the clinical trial at their site and any Satellite Site within their cluster under ICH GCP.

Principal Investigator: The Principal Investigator (PI) is the Investigator responsible for the conduct, management, monitoring and reporting of a trial at their own site.
Where the Teletrial Model is implemented, the Principal Investigator at the Primary Site assumes overall responsibility and provides oversight to Satellite Site(s), which may be geographically distanced, within a cluster. Associate Investigators at Satellite Site(s) operate under the direction and responsibility of the Principal Investigator at the Primary Site.
The Principal Investigator (PI) is responsible for overseeing all aspects of a clinical trial at a trial site, ensuring compliance with the protocol, maintaining participant safety, managing resources, delegating tasks to qualified staff, and communicating with regulatory bodies to uphold data integrity and ethical standards. The PI supervises Associate Investigators at geographically remote Satellite Sites using telehealth technology. This arrangement allows the trial to be conducted closer to patients' homes, particularly in regional, rural, and remote locations. The PI remains accountable for the overall conduct of the trial, ensuring compliance with regulatory standards and the trial protocol. A detailed Supervision Plan and a Delegation Log are required to document responsibilities and ensure proper oversight across all sites involved in the teletrial for discussion.

Public: Members of the public who use, or are potential users of health care services - patients, consumers, families, carers and other support people.

Regional Clinical Trial Coordinating Centre - RCCC: Under the Australian Teletrial Program, Regional Clinical Trial Coordinating Centre teams provide local support and expert advice to all teletrial stakeholders, including Sponsors, Sites, Human Research Ethics Committees, and Research Governance Officers. RCCCs offer operational support, funding, assistance and coordination of connected care cluster establishment and study start-up activities, as well as education and training.

Registered Research Nurse: A healthcare professional who combines clinical expertise with research skills to support and conduct clinical trials and research studies. They are critical in managing patient care, ensuring compliance with research protocols, and maintaining data integrity throughout the study. Registered Research Nurses are responsible for patient recruitment, informed consent, administration of study treatments, monitoring patient responses, and documenting outcomes. They possess strong clinical skills, attention to detail, and the ability to work collaboratively within multidisciplinary teams to advance healthcare through research.

Research: An original investigation undertaken to gain knowledge, understanding and insight. It involves the systematic collection and analysis of data with the aim of generating new knowledge, answering specific questions, or testing hypotheses.

Research institution: A place where research is conducted.

Research process: The planning, funding and conduct of an individual piece of research in addition to implementation of research findings and publication of research findings.

Researcher: An individual who performs a systematic investigation to develop or contribute to knowledge in their field.

Satellite Site: 1. A Satellite Site is located in a geographically separate health facility, with appropriate clinical research experience to participate in a cluster. Trial activities are delegated by the Primary Site (clinical trial site) to the Satellite Site, to enable performance of activities associated with the conduct of a clinical trial at the Satellite Site and to support trial accessibility of remote participants to a clinical trial. A clinical trial site that collaborates with a primary site to conduct clinical trials. The satellite site is often, but not always located in a rural, regional, or remote area, and operates under the supervision of a Primary Investigator at the primary site. This arrangement utilises telehealth technology to facilitate communication and trial activities, allowing patients to participate in clinical trials closer to home while maintaining the integrity and oversight of the trial.

2. A site delivering trial activities under agreement with, and responsibility of, the Primary Site Principal Investigator

3. The satellite site, which can be located in a rural, regional, or remote area, conducts delegated clinical trial activities under the supervision of the Principal Investigator at the primary site, allowing patients to participate in clinical trials closer to home while maintaining the integrity and oversight of the trial.

Satellite Site Sub-Contract to the Clinical Trial Research Agreement: A legally binding agreement that outlines and manages the relationship between the Primary Site and the Satellite Site, where the Satellite Site is a separate legal entity to the Primary Site. Endorsed after the CTRA/Head Agreement.

Stakeholders: An individual or group from within or outside research organisations with a key interest in research. This might include members of consumer organisations, professional bodies, government agencies, non-government organisations, industry, or research funders as well as consumers and community members. Stakeholders can provide support or expertise and may influence decisions about the research and its findings.

Start-up activities: The period before the actual commencement of a clinical trial when all necessary preparations are made. It includes tasks such as feasibility, site selection, ethics and regulatory document submission, site initiation and site personnel training.

Start-up specialist: A Clinical Research Coordinator that specialises in, or supports, start up activities at a site under the immediate direction of a Principal Investigator, whose research activities are conducted in accordance with Good Clinical Practice guidelines, the National Statement, and the National Clinical Trials Governance Framework.

Sub-Investigator: A qualified person designated and supervised by the Principal Investigator, responsible for conducting a clinical trial activity, and/or to make important trial related decisions, at a local coordinating site, which is geographically distant from the Principal Investigator’s Primary Site.

Telehealth: The provision of healthcare services through video or telephone consultations allowing patients to access healthcare remotely. This includes remote patient monitoring, the transmission of clinical information between healthcare providers (store-and-forward), and live consultations.

Telemedicine: A subset of telehealth that specifically involves the use of telecommunications technology to deliver clinical services. It focuses on providing medical consultations, diagnoses, and treatment plans remotely, often through video conferencing or phone calls. Telemedicine is used to connect patients with healthcare providers when an in-person visit is not possible, ensuring that patients receive timely medical care regardless of their location.

Teletrial: 1. Teletrial is a new, proven model for conducting clinical trials by connecting regional, rural and remote clinical trial sites to a primary site. The primary site supports local sites in building capacity and capability, promoting equitable health access and may lead to local sites becoming primary sites in the future. Teletrials involve numerous medical staff and researchers from various hospitals and health services in different locations. They use digital telecommunication to work as one team and conduct clinical trials closer to where patients live

2. A teletrial uses telecommunications technology to allow a Primary Site to work with a Satellite Site/s and deliver aspects of a clinical trial. This is outlined in a Supervision Plan, and allows a Principal Investigator to supervise Associate Investigator/s to conduct a clinical trial at a Satellite Site which is geographically remote from the Principal Investigator’s Primary Site. The Principal Investigator remains responsible for the trial and supervises the Associate Investigator/s at the Satellite Site/s. A cluster is a group of two or more sites conducting the same trial.

Teletrial Cluster: A group of sites involved in the same research activity, consisting of a Primary Site, which assumes overall responsibility, and one or more Satellite Sites.

Teletrial Supervision Plan: A plan that outlines the process and agreement for a Principal Investigator in the supervision of any individual or party to whom they delegate study related duties and functions carried out at a Satellite Site.

Wearables: Remote or wearable patient devices include non-invasive remote monitoring devices that measure or detect common physiological parameters and non-invasive monitoring devices that wirelessly transmit patient information to their health care provider or other monitoring entity.