Ethics and Governance Training Repository

Comprehensive Training Seminars on Research Ethics and Governance

At Monash Health, we understand the importance of proper research ethics and governance practices throughout the entire lifecycle of a project. Whether you’re just starting, joining an ongoing study, or closing out a completed project, our Ethics and Governance Training Repository has you covered.

Our flagship “Ethics and Governance 4 Part Series: Beginning to End and More” seminars provide a comprehensive, step-by-step guide to navigating the research ethics and governance process. These seminars cover:

  • Pre-submission requirements and considerations
  • Submission processes for all risk categories
  • Site-Specific Applications and Governance procedures
  • Informed consent best practices
  • Safety monitoring and reporting
  • Post-approval submissions and project amendments
  • Monitoring and auditing
  • Project close-out and archiving

Additionally, our Research Agreement Training session delves deeper into the legal and clinical aspects of research agreements.

For Monash Health staff, we offer convenient online training modules and an Electronic Medical Records (EMR) Alert Training Session, accessible through the Learning and Teaching Technology Environment (Latte) website.

Whether you’re a seasoned researcher or new to the field, our training resources equip you with the knowledge and tools to ensure ethical and compliant research practices every step of the way.

Session 1

  • Guidelines, Legislation, Policies and Procedures
  • Human Research Ethics Applications (HREA)
  • Ethical Review Manager (ERM)
  • Key Ethics Documents: HREA, Protocol, Victorian Specific Module, Investigator Brochure, Consent and Radiation Forms
  • Low Risk Projects
  • Quality Assurance Projects

Seminar Presentation – Session 1

Presentation Video (29 October 2020)

Session 2

  • Site Specific Assessment (Governance) Applications
  • Ethical Review Manager (ERM)
  • Supporting Departments
  • Participant Information and Consent Forms
  • Good Clinical Practice Training
  • Legal Documents: Agreements, Indemnities and Insurance
  • Monash University Financial Arrangements and Invoicing

Seminar Presentation – Session 2

Presentation Video (12 November 2020)

Session 3

  • Responsibilities of Investigators and Sponsors
  • Study Files and Essential Documents
  • Delegation, Training, Investigational Product and Case Report Forms
  • Data, Privacy, Recruitment
  • Informed Consent: Witnesses, Translations and Vulnerable Patients
  • Incompetent Patients and the Medical Treatment Planning and Decisions Act.

Seminar Presentation – Session 3

Presentation Video (24 November 2020)

Session 4

  • Post Approval Submissions
  • HREC & SSA Amendments
  • Safety Reporting
  • Protocol Breaches
  • Annual Progress Reports
  • Audits
  • Intellectual Property
  • Supplementary Information

Seminar Presentation – Session 4

Presentation Video (30 November 2020)

Research Agreement Training

  • Agreement Types
  • How to use Agreement Templates
  • Agreements and Agreement Variations
  • Non Standard Agreements
  • Financial Aspects
  • Legal Documents: Insurance and Indemnities

Research Agreement Training Video

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