Clinical Trial Toolkit

The National Teletrials Compendium, a significant deliverable from the Clinical Trials Project Reference Group, has now been released.

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

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

The Teletrials Compendium is consistent with the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), and also aligns with the 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. These 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.

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.

The zip files contains the following templates in PDF or Word format:

• 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 (customisable Word document for use by sites to document site-specific activities/procedures).

Contact us on how to use the SOPs
How will these SOPs be implemented?
All users are encouraged to provide feedback and suggestions for improvement, as well as any suggestions for additional SOPs during the current six month review period.

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• 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
• ISO 14155 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 for regulatory purposes
• Australian code for the responsible conduct of research
  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)
• 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
  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

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
• NIH e-Protocol Writing Tool
• SPIRIT Statement – evidence-based recommendations for the minimum content of a clinical trial protocol
• CONSORT Statement for reporting randomised clinical trials
• Good ReseArch for Comparative Effectiveness (GRACE)

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

• International Committee of Medical Journal Editors policy on clinical trial registration
• Australian and New Zealand Clinical Trials Registry

• NSW Health clinical trial budget costing tool
• NSWHP pricing tool
• 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

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 templates
• Lay summaries of clinical study results: an overview. Pharmaceutical Medicine (2019) 33:261–268