Resources for clinical trial researchers

Ethics guidelines and resources

• National Statement on Ethical Conduct in Human Research (2025)
• Australian Code for the Responsible Conduct of Research 2018
• Australian Clinical Trial Handbook 2024
• 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

• The Ethical Review Manager (ERM)  website is used for applications and reports to Victorian public hospitals’ research offices
  
•  Applicant User Guide to ERM September 2024

Standard Operating Procedures for Conducting Clinical Trials Research at Bendigo Health

SOP 1: Creation, Implementation and Revision of Clinical Trials Standard Operating Procedures

SOP 2: Investigator Responsibilities

SOP 3: Training and Qualifications

SOP 4: Protocol and Investigational Brochure Requirements

SOP 5: Communication with HREC, RGO, Sponsor and Institution's Insurer

SOP 6: Site Initiation

SOP 7: The Study Master File

SOP 8: Case Report Forms and Source Documents

SOP 9: Research Participant Informed Consent Process and Documentation

SOP 10: Handling and Shipping of Biological Substances (Cat B) and Dangerous Goods

SOP 11: Management of Investigational Product

SOP 12: Safety Data Monitoring and Reporting Requirements for Clinical Trials

SOP 13: Site Close-Out Archiving

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