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This page contains links to forms and guidelines.  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.

A

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]

C

Cover Sheets

Cover Sheet for research project (v16.1; Jun 2022)

Guidelines for completing the Eye and Ear Cover Sheet and Attachments (v1.0; 24 Aug 2020)

Attachment A – Clinical Trials (v1.3; Apr 2021)

Attachment B – Biospecimens and Genetic/Genomic Research (v1.2; 14 Oct 2020)

Attachment C – Privacy Requirements (v1.2; Nov 2020)

D

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

F

Final Report (v9; Feb 2019)

H

Honorary Researcher Application (v6.5; June 2022)

Human Research Ethics Application Form (HREA ) – via ERM system

I

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)

L

Low Risk Research Application Form (LNR VIC) via ERM system

N

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

P

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

Q

Quality Assurance Application Form (v2; Nov 2020)

Quality Assurance Supplementary Form – Privacy (v1; Sept 2018)

Quality Assurance Supplementary Form – Databanks (v2; Sept 2018)

Quality Assurance Final Report (v1; Jul 2020)

S

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)

V

Victorian Specific Module