Resources for clinical trial researchers

Ethics guidelines and resources

• National Statement on Ethical Conduct in Human Research_2007 (Updated 2018)
• Australian Code for the Responsible Conduct of Research_2018
• Australian Clinical Trial Handbook 2021
• Coordinating Office for Clinical Trial Research
• Ethical Guidelines for Research with Aboriginal and Torres Strait Islander Peoples
• ICH Guideline for Good Clinical Practice 2018

Submitting your Ethics and Governance Application

• Applicant user guide to ERM April 2021
• Guidelines for the Victorian-Specific Module

Standard Operating Procedures for Conducting Clinical Trials Research at Bendigo Health

1. Preparation, Approval, Review and Issue of SOPs Related to Clinical Trial Research
2. Clinical Trial Research Training
3. Clinical Trial Research Delegation of Duties
4. Clinical Trial Feasibility and Start-Up
5. Management of Safety Information for Clinical Trial Research
6. Hosting a Regulatory Inspection, Sponsor- or HREC-Initiated Audit
7. Handling and Shipping of Biological Substances for Clinical Trial Research
8. Clinical Trial Research Document Version Control
9.  Research Participant Informed Consent Process and Documentation
10. Essential Document Management for Clinical Trial Research
11. Archiving Clinical Trial Research Documents

Please click here for links to Bendigo Health-specific Tools and Templates.