Researcher Resources
The clinical research environment is complex and cuts across ethical, scientific, governance, legislative and regulatory domains. Conducting clinical research can be challenging and links to a range of useful resources are provided in the pages below.
Forms Templates and Guidelines
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)
Agreement – Medicines Australia Clinical Trial Research Agreements
Agreement – Medical Technology Association of Australia Clinical Investigation Research Agreement
Amendment Request Form (v5.2; Jan 2021)
Annual Report and Self Audit Form (v25.2; Mar 2023)
Annual Safety Report (DHHS form)
C
Cover Sheets
Cover Sheet for research project (v16.1; Jun 2022)
Cover Sheet Guidelines for completing the Eye and Ear Cover Sheet and Attachments (v1.0; Aug 2020)
Cover Sheet Attachment A – Clinical Trials (v1.3; Apr 2021)
Cover Sheet Attachment B – Biospecimens and Genetic/Genomic Research (v1.2; Oct 2020)
Cover Sheet 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 Vic Application Form – 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 under the Ethics Application Tab
Q
Quality Assurance Application Form (v2; Nov 2020)
Quality Assurance Supplementary Form – Privacy (v1; Aug 2018)
Quality Assurance Supplementary Form – Databanks (v2; Sept 2018)
Quality Assurance Progress/Final Report (v1; Jul 2020)
S
Safety Reporting Form (v11; Apr 2025)
Site Specific Assessment Form – via ERM system
Supporting Department Declaration (v3; Feb 2021)
V
Victorian Specific Module – via ERM system
