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. Creation, Implementation and Revision of Standard Operating Procedures
2. Investigator Responsibilities
3. Training and Qualifications
4. Protocol and Investigational Brochure Requirements
5. Communication with HREC, RGO, Sponsor and Institation's Insurer
6. Site Initiation
7. The Study Master File
8. Case Report Forums and Source Documents
9. Research Participant Informed Consent Process and Documentation
10. Handling and Shipping of Biological Substances (Cat B) and Dangerous Goods
11. Management of Investigational Product
12. Safety Data Monitoring and Reporting Requirements for Clinical Trials
13. Site Close-Out Archiving

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