The separation of responsibility for the governance of research from ethical review of that research is a key concept underpinning the introduction of multisite ethical review models in Victoria and elsewhere.
The preparation of the documents that form the Governance Application can begin before the ethical approval of a project. The collection of signatures and supporting department approvals, and the negotiation of the contract if needed, is time consuming and early preparation is required to allow for prompt governance approval after ethical approval has been issued.
Governance review of research projects is carried out by the staff of the Human Research Ethics & Governance office, in particular the Research Governance Officer, and authorisation to conduct a research project at Peter Mac is issued by the Human Research Ethics & Governance office.
EPIC Electronic Medical Record (EMR)
Pre-Submission Survey: All new projects that will run at the Peter MacCallum Cancer Centre must complete the EPIC EMR Pre-Submission Survey. If your project was reviewed by the Peter Mac HREC you may have already completed this survey. If your project was reviewed by another HREC you must complete this survey now. You will require your 5-digit ERM number to complete the survey. This is the 5-digit number generated by the ERM submission system e.g. SSA/XXXXX/PMCC.
Research Participants: The Peter Mac patient brochure 'What happens to information about you?' must be provided to all patients being recruited to a research project that will access the patients medical record. This brochure is found on iPolicy as PIP126.96.36.199 What happens to information about you?
ERM (Ethics Review Manager) submission system: Useful advice on how to create, submit and manage your ethics and research governance applications in ERM can be found at National Mutual Acceptance.
- Site Specific Assessment Form (SSA) List only Investigators working on the project at the Peter Mac site. SSA must be signed by listed Principal Investigator and Associate Investigators, Heads of Supporting Departments; Principal Investigator's Head of Department. Advice on creating a SSA form across different states can be found at National Mutual Acceptance.
- CV: Peter Mac site Principal Investigator and Associate Investigator CVs, if not already submitted within the last two years
- GCP: For all interventional clinical research projects all investigators must provide evidence of current GCP training. Researchers on all other human research projects are strongly encouraged to undertake GCP training. Peter Mac provides GCP training.
- Standard Indemnity provided by a commercial sponsor (if commercially sponsored project) Refer to the Peter Mac contact details for use in Indemnities.
- Insurance Certificate provided by a commercial sponsor (if commercially sponsored project).
- Agreement: Fully signed Clinical Trial Research Agreement or Clinical Investigation Research Agreement or Investigator Initiated Clinical Trial Research Agreement or other Research Agreement between Peter Mac and project sponsor (if applicable). Important Note: Contracts require review by the Peter Mac General Counsel. Find Peter Mac contact details for use in contracts.
- Radiation: Provide the radiation report for Peter Mac site (if project uses radiation).
If the reviewing HREC is an external Ethics Committee, please also include:
- Ethical Approval(s) from the external Ethics Committee. The Ethics Approval(s) should list most recent approved documents and list Peter Mac as a site included under the approval.
- Ethically-approved project documentation (e.g. Protocol, Investigator Brochure, master PICF/s and any other master documents).
- Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) for unapproved therapeutic goods, if required. The CTN is an online form. Please include a PDF of the filled in CTN for review. Refer to the Peter Mac contact details for use in CTNs
Site specific documents
Multi-site ethical review projects only, please also include:Site specific documents based on the ethically approved master documents e.g. site-specific Participant Information and Consent Form (PICF) on Peter Mac letterhead. Find Peter Mac details for use in PICFs
NOTE: Site specific project documents must have a version/date inserted in the footer of all pages. An example for a site specific PICF is: PMCC PICF version X dated day month year based on master PICF version X dated day month year. This provides for quick and accurate identification of the current approved documents to be used by the project team.
Governance applications can be submitted at any time.
- Please ensure that all required documents are completed and that the electronic files are clearly labelled.
- Submit the SSA and all other forms and project documents.
- Standard Indemnity: Submit e-signing request.