Guidelines, Report Templates and Checklists

The following guidelines are provided to assist researchers with preparation of their research application as well as guidance for adverse events:

• Guidelines For Submissions
• Conducting Research
• Clinical Trials Compensation Guidelines

Reporting Templates

Investigator Progress Report – Once a HREC application is approved, a yearly progress report is required to be submitted to the HREC each year the research is conducted on the date of approval.

•      HREA Investigator Progress Report
•      LNR Investigator Progress Report

Investigator Final Report – Once the research is complete, a final report must be submitted to the HREC, as well as any publications made regarding the research.

• HREA Investigator Final Report
• LNR Investigator Final Report

In the instance of any adverse events which may occur, investigators are required to complete a serious event report and submit it to the HREC.

• Investigator Serious Adverse Event (SAE) Report

Additional Templates

• Conducting Research: Some Basic Points To Consider
• Submission Checklist
• Guidelines For Participants
• NHMRC Standardised Participant Information and Consent Form Templates
• Waiver of Consent Criteria Checklist
• Conflict of Interest Declaration
• New Protocol Application Form
• Study Commenced, Discontinued or Withdrawn
• Investigator Report of CIOMS or IND Safety Reports
• RANZCO Sample Protocol (for guidance only)