Clinical Trial Toolkit

The following documents make up the guiding principles on which research is to conducted in the Australian clinical trials environment.

• Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)
  Internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. The Guideline for Good Clinical Practice is incorporated by reference in the Therapeutic Goods Regulations 1990. Compliance with the Guideline is a condition of approval for the conduct of a clinical – ICH E6 (R3) has been released for public consultation and will be implemented accordingly.
• ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice
  Good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices
• Australian code for the responsible conduct of research (2018)
  Establishes a framework for responsible research conduct that provides a foundation for high-quality research, credibility and community trust in the research endeavour
• National statement on ethical conduct in human research 2007(updated 2018)- new update will be released shortly, effective early 2024
• Australian clinical trial handbook
  Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods
• Therapeutic Goods Administration clinical trial notification/clinical trial exemption schemes
  Notification of a clinical trial to Australia’s regulatory agency the Therapeutic Goods Administration NHMRC safety monitoring and reporting in clinical trials (2016). Clarifies the responsibilities of those involved in clinical trials to monitor and report adverse events and other safety issues
• Data safety monitoring boards (DSMBs)
  Advice from regulatory authorities, clinical trial groups and industry organisations on the use of DSMBs
• Risk-based management and monitoring of clinical trials involving therapeutic goods 2018
  Advice from regulatory authorities, clinical trial groups and industry organisations on the application of risk-based trial processes
• Reporting of serious breaches of GCP or the protocol for trials involving therapeutic goods
  Advice from regulatory authorities, clinical trial groups and industry organisations on the reporting of deviations from GCP or the protocol

For further information on Australian guidelines related to clinical trials, please visit the Commonwealth Department of Health and Aged Care’s Australian Clinical Trials website

The National Teletrials Compendium, is a significant deliverable from the Clinical Trials Project Reference Group (CTPRG). 

The National Teletrials Compendium supports a national approach to teletrials and consists of two publications: 

• The National Principles for Teletrials in Australia 
• The National Standard Operating Procedures for Clinical Trials, including Teletrials in Australia 

The compendium was developed to assist organisations engaged in conducting trials in Australia to, wherever possible, standardise their procedures for key operations related to clinical trials and specifically teletrials. The documents have been endorsed by all states and territories, together with the Therapeutic Goods Administration (TGA) and the National Health and Medical Research (NHMRC) through the CTPRG. 

Compliance with the compendium provides public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data generated from clinical trials are credible. 

The documents are consistent with the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), and also aligns with the National Clinical Trials Governance Framework, which has been designed to support the delivery and integration of high-quality clinical trials service provision into routine hospital care for improved patient outcomes. The National Principles for Teletrials are also consistent with recommendations from the Clinical Oncology Society of Australia’s (COSA) Australasian Teletrial Model – A National Guide to Implementation, September 2016. 

Requests and inquiries concerning reproduction and other rights to use the documents, are to be sent to the Communication Branch, Commonwealth Department of Health, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au. 

The National Principles for Teletrials and the standard operating procedures have been developed to assist organisations engaged in conducting trials in Australia to, wherever possible, standardise their procedures for key operations related to clinical trials and specifically teletrials. They have been endorsed by all states and territories, together with the Therapeutic Goods Administration (TGA) and the National Health and Medical Research (NHMRC) through the CTPRG.

Compliance with the Teletrials Compendium provides public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data generated from the clinical trials are credible.

Requests and inquiries concerning reproduction and other rights to use are to be sent to the Communication Branch, Commonwealth Department of Health, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au.

This section is currently under review.  

For further guidance on Standard Operating Procedures (SOPs) please see the National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia. These documents were published in 2021 and aim to help organisations standardise their clinical trial related procedures. The SOP templates have been agreed by all states and territories.      

The list below provides a guide to common SOPs considered best practice for sites to maintain:      

• clinical trial training and qualification 
• hosting an audit or regulatory inspection 
• sub-contracting of external vendors 
• trial feasibility and start-up 
• delegation of duties by the principal investigator 
• informed consent 
• managing and reporting safety events 
• reporting non-compliance and suspected breaches of GCP or the protocol 
• investigational medicinal product management and emergency unblinding 
• source data and case report form completion 
• handling and transporting biological specimens 
• investigator site file and essential documents 
• close-out at a trial site 
• clinical trial archiving 
• work instruction site templates  

The Protocol is the document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organisation of a clinical research project. 

• See section 6 of Guideline for Good Clinical Practice 
• TransCelerate Common Protocol Template – provides proposed harmonised content and streamlined format for clinical trial protocols. 
• NIH e-Protocol Writing Tool – The electronic protocol writing tool aims to assist the development of Phase 2 and 3 IND/IDE Clinical Trial Protocol templates as well as Behavioral and Social Sciences Research Involving Humans Protocol templates. The tool has been developed through the National Institutes of Health (NIH) Office of Science Policy. 
• SPIRIT Statement – SPIRIT Checklist 2013 and SPIRIT-Outcomes 2022. Widely endorsed, evidence-based recommendations for the minimum content of a clinical trial protocol. 
• CONSORT Statement for reporting randomised clinical trials. Specialised reporting guidelines are also available via this link to the Enhancing the Quality and Transparency Of health Research (EQUATOR network) website.   
• Good ReseArch for Comparative Effectiveness (GRACE) – good research practice principles for Observational Studies of Comparative Effectiveness   

The investigator’s brochure is a compilation of the clinical and non-clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects: 

• • See section 7 of Guideline for Good Clinical Practice 
  • ICH GCP – 7. INVESTIGATOR’S BROCHURE: ICH E6 (R2) Good clinical practice 

In August 2005 the World Health Organization (WHO) launched its International Clinical Trial Registry Platform (ICTRP). The ICTRP’s main objectives are to ensure that all clinical trials are registered and can be easily found, as well as setting standards for good registry practice. The Australian and New Zealand Clinical Trials Registry (ANZCTR) is part of this worldwide initiative. 

• WHO primary registries – There are currently 17 primary registries in the WHO Registry Network.  
• ICTRP global search portal – The 17 Primary Registries plus the US-based registry, ClinicalTrials.gov, all contribute data to the search portal.   
• Australian and New Zealand Clinical Trials Registry 
• ClinicalTrials.gov – US based registry 
• International Committee of Medical Journal Editors policy on clinical trial registration 

• NSW Health clinical trial budget costing tool
• NSW Health Pathology Statewide pricing guide 
• Clinical trial research agreements for sponsors, clinical research organisations, collaborative research networks and Phase IV trials
  • Medicines
  • Medical technology
• Indemnity and compensation guidelines
  • Medicines
  • Medical technology
• Insurance
• IP Australia non-disclosure agreement – is a legal contract, which should be used when sensitive information needs to be shared between two parties (Australian Government) 
• Intellectual Property & Commercialisation Framework – The Office for Health and Medical Research 

Provides information about a clinical trial to prospective participants and a mechanism for obtaining their written consent to participate. 

• National participant information and consent form (PICF) 
• Patient ID card – An identity card is given to participants in clinical trials. This card is approved by the studies ethics committee and contains information about the participant and study that is particularly useful in an emergency. For example, it may contain the study title, name and contact details of the Principal Investigator (PI), important study safety considerations and an emergency contact number in case the PI is not immediately contactable.     
• Lay summaries of clinical study results: an overview. Pharmaceutical Medicine (2019) 33:261–268