Clinical trials toolkit

ICH Guideline for Good Clinical Practice
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.
Source: Therapeutic Goods Administration

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.
Source: International Organization for Standardization

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.
Source: National Health and Medical Research Council

National Statement on Ethical Conduct in Human Research
Source: National Health and Medical Research Council

Australian clinical trial handbook
Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods.
Source: Therapeutic Goods Administration

Clinical trial notification and exemption schemes
Notification of a clinical trial to Australia’s regulatory agency, the Therapeutic Goods Administration.
Source: Therapeutic Goods Administration

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. Includes advice on risk management and data safety monitoring boards, reporting breaches of good clinical practice.
Source: National Health and Medical Research Council

Australian Clinical Trials
Information about running clinical trials for researchers, healthcare providers, industry and participants.
Source: Australian Government

International Clinical Trial Registry Platform
Includes 17 primary clinical trial registries in a single platform.
Source: World Health Organization

Australian and New Zealand Clinical Trials Registry

Policy on clinical trial registration and data sharing
Source: International Committee of Medical Journal Editors

NSW Health clinical trial budget costing tool
Source: Office for Health and Medical Research

Statewide pricing guide
Clinical trial research agreements for sponsors, clinical research organisations, collaborative research networks and Phase IV trials.
Source: NSW Health Pathology

Clinical Investigation Research Agreements
For commercially sponsored studies of medical technology.
Source: Medical Technology Association of Australia

Indemnity and insurance arrangements for clinical trials
A review of indemnity and insurance arrangements concerning clinical trials across the public and private sectors.
Source: National Health and Medical Research Council

Non-disclosure agreement (NDA)
What is an NDA, when to use one. Contract generator.   
Source: IP Australia

Intellectual Property and Commercialisation Framework
The policies in NSW Health supporting public value, knowledge transfer, innovation and commercialisation
Source: Office for Health and Medical Research

Participant information and consent form templates
Templates and user guides for researchers.
Source: National Participation Information and Consent Form

Lay summaries of clinical study results
This article gives some ideas to think about when writing lay summaries.
Source: Pharmaceutical Medicine

Identity cards

An identity card is given to participants in clinical trials.

This card is approved by the study’s ethics committee. It 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, important study safety considerations and an emergency contact number in case the principal investigator is not immediately contactable.