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.
Preparing your governance application
Governance Application Forms
- Site Specific Assessment Form (SSA) List only Investigators working on the project at the Peter Mac site. Advice on creating a SSA form across different states can be found at National Mutual Acceptance.
- Peter Mac Investigator CVs, if not already submitted within the last two years
- 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).
- 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.
The following documents are required for multi-site ethical review projects only:
Site specific documents based on the ethically approved master documents e.g. site-specific Participant Information and Consent Form (PICF) on Peter Mac letterhead (if you are a Peter Mac employee, access via the intranet. For outside access please contact the ethics secretariat). 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.
If Peter Mac Ethics Committee is the reviewing HREC:
All documents already submitted to the Peter Mac Ethics Committee for ethical review and all correspondence issued by/on behalf of the Peter Mac Ethics Committee are available to the Peter Mac Ethics Secretariat staff and the Peter Mac Research Governance Officer and do not need to be submitted again.
If the reviewing HREC is an external Ethics Committee, please also include the following additional documents:
- 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.
- A copy of the ethics application forms as reviewed by the external Ethics Committee e.g. HREA and VSM.
- 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
Submitting your governance application
- 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.
- The Standard Indemnity is the only document required in hard copy, please deliver or post as per the below.
Peter MacCallum Cancer Centre
Level 4, 305 Grattan Street
Melbourne VIC 3000
Peter MacCallum Cancer Centre
Locked Bag 1 A'Beckett Street
Melbourne VIC 8006
The Principal Investigator will be advised of the outcome of the review and any further queries or requirements.