Welcome to Monash Health’s Forms Library. Here, you can find everything you need for your research project, all in one convenient location.
Monash Health is aligning our 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.
Recent Updates – For ease of reference, please see the Policy & Procedure Update Summary 2023, which lists the policies and procedures that have recently been amended.
Urgent Issues – For urgent matters, particularly those involving patient safety, please contact our team immediately by phone. Refer to the Research Support Services Contact List for contact details.
Explore the forms and resources available to ensure your research project is compliant and well-supported.
Complaints
- Handling of Research Misconduct and Resolving Allegations Procedure
- Research Related Feedback (complaints and compliments)
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
- Recruitment of Incompetent Patients into Research
- Telephone Script for Obtaining Consent for Remote Access to EMR by Sponsors of Clinical Trials
- Waiver of Consent
Consumers
- Consumer, Carer and Community Participation Framework
- Consumer Guide to Clinical Trials
- Consumer Involvement in Research Development
- Is a Clinical Trial right for you? (English translation)
- Partnering with Consumers
Contact Information
Fees
Honorary Researchers
Legal Documents
- Agreements
- Agreement – CT Collaborative Research Agreement
- Agreement – Data Transfer Agreement for Monash Health providing data
- Agreement – Ethical Review of Human Research Services
- Agreement – Investigator Initiated with Commercial Support
- Agreement – Material Transfer Agreement Template
- Agreement – Monash Partners Collaborative
- Agreement – Material Transfer Agreement (MTA) Template
- 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 Meeting Dates 2024
- HREC 2025 Booking, Submission & Meeting Dates
- Human Research Ethics Review and Site Authorisation Procedure
- Monash Health Human Research Ethics Committee Terms of Reference 2023
Privacy
- Data and Records Procedure
- Research Data Storage, Retention, Privacy & Confidentiality
- 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 (updated 2018)
- NHMRC Health and Human Research Ethics
- Potential research opportunities for junior clinical staff
- Therapeutic Goods Administration
Quality Assurance and Negligible Risk
Radiation
Research Collaborators
- 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
- Collaborative Research Across Institutions Procedure
- Conflict of Interest Procedure – People and Culture
- Good Clinical Practice Training in Research
- Handling and Shipping of Infectious Substances for Clinical Trials
- Home Visits to Clinical Trial Participants
- Human Research Strategic Policy
- Monitor Vaccination Requirements
- Progress Report Submission Form
- Progress Report Procedure
- Progress Report Sample Document
- 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
- Use of Interpreters in Human 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
- Certification by Head of Pharmacy
- Clinical Trials Centre (CTC) Feasibility Form
- CTC Billing & Feasibility App
- Form 4C Emergency Department
- Monash Emergency Research Proposal