Find everything you need for your Research Project all in one place.
Research Support Services Festive Closure – Research Support Services will be closed from 5:00pm on Thursday 22 December 2022 and will re-open at 8:30am on Tuesday 03 January 2023. In order for researchers to receive a response to items such as; post-approval amendments, project notifications, new governance applications/site authorisation applications, HREC conditions of approval or Quality Assurance applications, the item must be submitted no later 5:00pm on Thursday 15 December 2022. This enables time for the team to seek advice from HREC members (if required) and manage the high workload.
New applications for Low Risk Human Research Ethics Review or Full Human Research Ethics review for 2022 close at 5:00pm on Wednesday 23 November 2022. New Applications for 2023 are open from 03 January 2023 for consideration at the 02 February 2023 HREC meeting.
For urgent issues i.e. an issue involving patient safety, please contact the team by phone in the first instance Research Support Services Contact List.
Complaints
- Handling of Research Misconduct and Resolving Allegations Procedure
- Research Related Complaint Resolution Procedure
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
- Informed Consent and Writing Patient Informed Consent Forms Procedure
- 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 Guide to Clinical Trials
- Consumer Involvement in Research Development
- Partnering with Consumers
Contact Information
Fees
Honorary Researchers
Legal Documents
- Arranging Payment between Monash Health & Monash University (Letter)
- 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 – Monash Tripartite – Sponsor Template
- Agreement – Monash Tripartite – CRO Local Sponsor Template
- Agreement – Material Transfer Agreement (MTA) Template
- Agreement – Monash Tripartite – MTAA (Device Trial) Template
- Agreement Invoice Details for Monash Health & Monash University
- Certificate of Insurance
- Guidance for Monash Partners Collaborative Agreement Template
- Medicines Australia – Indemnity and Compensation Template and Guidelines
- Victorian Managed Insurance Authority
Monitoring & 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
- Self Audit Tool – Research Governance
- Short Audit Template – Research Governance
New Project Submissions
- Early Phase Clinical Trials Human Research Ethics Review Policy Procedures
- HREC Radiation Notification Letter
- Human Research Ethics Review and Site Authorisation Procedure
- Monash Health Human Research Ethics Committee Terms of Reference 2021
- Protocol & Investigational Brochure Content, Design, Amendments & Compliance
- Quality Assurance Policy Procedure
Privacy
Professional Development & Resources
- 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)
- 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 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
- School of Clinical Science
Research Governance Resources
- Authorship for Research Procedure
- Australian Clinical Trials Registry
- Australian Code for the Responsible Conduct of Research
- Collaborative Research Across Institutions Procedure
- Communication with Human Research Committee, Trial Sponsor and Insurer Procedure
- Conflict of Interest Procedure – People and Culture
- Good Clinical Practice Training Research Operational Policy
- Handling and Shipping of Infectious Substances for Clinical Trials
- Home Visits to Clinical Trial Participants
- Human Research Strategic Policy
- Investigator Responsibilities Procedure
- Investigation Site Qualifications, Adequacy of Resources & Training
- Medicare Eligibility for trial participation (Operational)
- Monitor Vaccination Requirements
- Peer Review Procedure
- Publication and Dissemination of Research Findings Procedure
- Receipt and Handling of Investigational Product
- Relationships with Industry Procedure – People and Culture
- Research Ethics and Governance Safety Reporting Requirements
- Site Initiation and Close Out
- Sponsor Responsibilities in Investigator Initiated Studies
- Study Site Master File and Documents
- Supervision of Research Trainees
- Use of Human Tissue in Research Procedure
Supporting Department
- Supporting Department – Certification by Head of Cardiology
- Supporting Department – Certification by Head of Diagnostic Imaging
- Supporting Department – Certification by Head of Department (General/Other Departments)
- Supporting Department – Certification by Head of Lung Function
- Supporting Department – Certification by Head of Pathology
- Supporting Department – Certification by Head of Pharmacy
- Supporting Department – Form 4T Clinical Trials Centre
- Supporting Department – Form 4C Emergency Department
- Supporting Department – Monash Emergency Research Proposal