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Forms listing

This page contains links to forms only.  It is recommended that you also consult the full information on the relevant pages which includes detailed information regarding site specific requirements, submission dates and the different requirements for single-site and multi-site research


Addition of Research Team Member (v1.2; Mar 2021)

Adverse Event Reporting Form (v10; Oct 2019) 

Agreement - Medicines Australia Clinical Trial Research Agreements

Agreement - Medical Technology Association of Australia Clinical Investigation Research Agreement

Agreement - Company Supported Study

Amendment Request Form (v5.2; Jan 2021)

Annual Report and Self Audit Form (v25.1; Apr 2021)

Annual Safety Report [download form DHHS website]




Eye and Ear Cover Sheet for New Research Project (MS Word; v15.5 dated April 2021)

Cover Sheet for Reapplication (MS Word; version 4.1 dated November 2020)

Guidelines for completing the Eye and Ear Cover Sheet and Attachments (MS Word; version 1.0 dated 24 August 2020)

Attachment A - Clinical Trials (MS Word; version 1.3 dated Apr 2021)

Attachment B - Biospecimens and Genetic/Genomic Research (MS Word; version 1.2 dated 14 October 2020)

Attachment C - Privacy Requirements (MS Word; version 1.2 dated November 2020)



Data Safety Monitoring Board Reporting Form (v1; Oct 2019)

Deviation and/or Violation Reporting Form (v3; Oct 2019) - not to be used for clinical trial projects



Final Report (v9; Feb 2019)



Honorary Researcher Application Form (v6.2; Oct 2021)

Human Research Ethics Application Form (HREA via ERM)



Indemnity – Standard Form and HREC Review Only - Medicines Australia

Indemnity – Standard Form and HREC Review Only - Medical Technology Association of Australia


Investigator Brochure Revision Form (HREC) (v2; Jan 2020)



Low Risk Research Application Form (LNR VIC via ERM)


Non-Serious Breach-Deviation Report Form (DHHS form)


Participant Information and Consent Form (PICF) templates can be found via the Victorian Government Clinical Trials and Research website 



Safety Report Form (Redirect to DHHS website) (from 1 April 2019)

Serious Breach Report Form (Redirect to DHHS website) (from 1 April 2019)

Site Specific Assessment Form (Gov)

Supporting Department Declaration (v3; Feb 2021)


Victorian Specific Module


Last updated 11 March 2021