Essential Forms, Templates and Resources
Policy & Procedures Update 2025
Monash Health aligns its policies and procedures with the National Standard Operating Procedures for Clinical Trials and the Australian Code for the Responsible Conduct of Research Guidelines. We recommend referring to these documents first. In the event, the issue is not covered by either of these documents, please refer to the Monash Health documents below.
Please see the Policy & Procedure Update 2025 for a detailed list of recently amended Policies & Procedures.
Need help? Speak to our Chatbot
Repository
Complaints
Consent
- Australian Paediatric Ethics and Governance Network – Clinical Trials the child participant and consent: A practical guide for investigators and sponsors
- Consent for Clinical Trial Sponsors to obtain access to EMR via Telephone
- Consent – Electronic (eConsent)
- Coordinating Office for Trials and Clinical Research – Templates for Participant Information and Consent Forms
- Guide to Risks
- Language Guidelines – How to use Plain Language Guide
- Research involving people who may be unable to give consent
- Research Participant Information and Consent Forms
- Telephone Script for Obtaining Consent for Remote Access to EMR by Sponsors of Clinical Trials
- Use of Interpreters in Human Research
- Waiver of Consent
Consumers
- Consumer, Carer and Community Participation Framework
- Consumer Guide to Clinical Trials
- Consumer Involvement in Research Development
- How is a Medicine Made
- Is a Clinical Trial right for you? (English translation)
- Medicare Eligibility for Trial Participation Procedure
- Partnering with Consumers
Contact Information
Fees
Good Clinical Practice (GCP) Providers
- Australian Clinical Trials Education Centre (A-CTEC)
- Good Clinical Practice Training in Research
- Monash Partners
- National Institute of Health
Honorary Researchers
Legal Documents
- Agreements
- CT Collaborative Research Agreement
- Data Transfer Agreement for Monash Health Providing Data
- Data Transfer Agreement for Monash Health Receiving Data
- Ethical Review of Human Research Services Agreement
- Material Transfer Agreement Template
- Victorian RTC Collaboration Agreement Guidelines
- Victorian RTC Research Collaboration Agreement
- Insurance
- Agreement Guidelines and Procedures
Monitoring and Remote Access
- Confidentiality Undertaking for External Researchers
- Health Information Services Access Requests
- NHMRC (2016) Guidance on ‘Safety monitoring and reporting in clinical trials involving therapeutic goods’
- Remote Access to Electronic Medical Records (EMR) by Sponsors of Commercially Sponsored Clinical Trials
- Research Ethics and Governance – Safety Reporting
- Self Audit Tool – Research Governance
- Short Audit Template – Research Governance
New Project Submissions
- Early Phase Clinical Trials – Human Research Ethics Review Policy & Procedures
- GMO and Gene Therapy Trials – Human Research Ethics Review & Site Authorisation/Governance
- HREC Radiation Notification Letter
- HREC 2025 Booking, Submission & Meeting Dates
- Human Research Ethics Review Checklist for Research Projects
- Human Research Ethics Review and Site Authorisation Procedure
- Monash Health Human Research Ethics Committee Terms of Reference 2025
Privacy
- Research Data Storage, Retention, Privacy & Confidentiality
- REDCap Access Procedure
- Waiver of Consent Procedure
Professional Development and Resources
- Australian Clinical Trials Education Centre (A-CTEC)
- Biostatistician Application Form
- Clinical Trial and Research Website
- Deakin – Monash Health Nursing Research Centre
- Ethics and Governance Seminar Series – Ethics Training Videos & Slideshows
- Ethical Review Manager (ERM)
- ERM Ethics Process (Victoria)
- ERM SSA Process (Victoria)
- ERM Alerts in Clinical Research
- Introduction to ERM
- Library – Monash Health
- Research Repository
- National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia
- National Statement on Ethical Conduct in Human Research (NHMRC 2023)
- NHMRC Health and Human Research Ethics
- Potential research opportunities for junior clinical staff
- Therapeutic Goods Administration
Quality Assurance and Minimal Risk Projects
Radiation
Research Collaborators
- Deakin University Centre for Quality & Patient Safety Research – School of Nursing & Midwifery
- Deakin University School of Nursing & Midwifery
- Hudson Institute of Medical Research
- Monash Comprehensive Cancer Consortium
- Monash Partners
- Monash University
- Monash University Faculty of Medicine, Nursing and Health Sciences
- Monash University (School of Clinical Sciences at Monash Health)
- Research at Jessie McPherson Private Hospital (Procedure)
Research Governance Resources
- A-CTEC Good Clinical Practice (Free Course)
- Australian Clinical Trials Registry
- Australian Code for the Responsible Conduct of Research
- Clinical Trial Notification Cheat Sheet for Monash Health Research Projects
- Collaborative Research Across Institutions Procedure
- Conflict of Interest Procedure – People and Culture
- Final Report Form Questions
- Handling and Shipping of Infectious Substances for Clinical Trials
- Home Visits to Clinical Trial Participants
- Human Research Strategic Policy
- Monitor Vaccination Requirements
- Progress, Final and Site Closure Reports Procedure
- Progress Report Form Questions
- Research Conduct Under the Clinical Trials Notification Scheme procedure
- Site Closure Report Submission Form
- Site Closure Report Form Questions
- Site Specific Authorisation Checklist for Research Projects
- Relationships with Industry Procedure – People and Culture
- Research Governance and Site Authorisation
- Sponsor Responsibilities in Investigator Initiated Studies
- The Use of Human Biospecimens in Research
Supporting Department/s
- Certification by Head of Cardiology
- Certification by Head of Diagnostic Imaging
- Certification by Head of Department (General/Other Departments)
- Certification by Head of Lung Function
- Certification by Head of Pathology
- Memo – Changes to Certification by Head of Pathology
- Certification by Head of Pharmacy
- Clinical Trials Centre (CTC) Feasibility Form
- CTC Billing & Feasibility App
- Form 4C Emergency Department
- General Service Request Certification by Head of Support
- Monash Emergency Research Proposal