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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

A

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 (v4; Apr 2018)

Annual Report and Self Audit Form (v25; Oct 2019)

Annual Safety Report [download form DHHS website]

 

C

Change of a Research Team Member (v7; Sept 2019)

COVER SHEETS

Eye and Ear Cover Sheet for New Research Project (MS Word; version 15.1 dated 20 August 2020)

Cover Sheet for Reapplication (MS Word; version 4 dated 24 August 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 1.1 dated 19 August 2020)

Attachment B - Biospecimens and Genetic/Genomic Research (MS Word; version 1.1 dated 24 August 2020)

Attachment C - Waiver of Consent / Opt-out Consent (MS Word; version 1.1 dated 10 September 2020)

 

D

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

 

F

Final Report (v9; Feb 2019)

 

H

Honorary Researcher Application Form (v5; Nov 2019)

Human Research Ethics Application Form (HREA via ERM)

 

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)

 

P

Participant Information and Consent Form can be found via the Department of Health and Human Services 

Research Project Deviation and/or Violation Reporting Form (v3; Oct 2019)

 

R

Research Supporting Department Declaration (v2; Aug 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)

 

V

Victorian Specific Module

 

Last updated 26 August 2020