ERM (Ethics Review Manager) submission system
Useful advice on how to create, submit or manage your ethics and research governance applications in ERM can be found at National Mutual Acceptance.
Preparing your governance review 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.
- Research Agreement and/or other Agreement (only applicable if project is being run by an external organisation) Important Note: Contracts require review by the Peter Mac General Counsel. Refer to the Peter Mac contact details for use in Contracts.
- Peter Mac Investigator CVs, if not already submitted within the last two years.
- Researchers on all human research projects are strongly encouraged to undertake GCP training. Peter Mac provides GCP training, See useful resources, training and forms.
The following documents are required for multisite 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). Refer to the Peter Mac site contact 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. LNR VIC application form
- Ethically-approved project documentation (e.g. Protocol, master PICF/s and any other master documents)
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 Principal Investigator will be advised of the outcome of the review and any further queries or requirements.