New Governance Application

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 (Human Research Ethics Committee) 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 ERM (Ethics Review Manager) number to complete the survey. This is the number generated by the ERM submission system, for example, SSA/XXXXX/PMCC.  

Research Participants 

The Peter Mac patient brochure 'What happens to information about you?' must be provided to all patients being recruited for a research project that will access the patients' medical record. This brochure is found on Prompt (access via CONNECT).

Data Release Request Procedure

All Peter Mac data request and releases must follow the below process:

1. Researchers will be required to submit a request to the Peter Mac Data Governance Office (DGO) by filling in the Peter Mac Data Request Form via REDCap.
2. The DGO team will review the request and consult with all the offices that need to give approval before the data may be released. This could be the Legal team, the HIS Privacy Officer, the Human Research Ethics and Governance (HREG) office, or others, as appropriate. The approvals to release the data will be recorded by the DGO team in REDcap.
3. Once the data release has been fully approved, the DGO will contact the requester and provide instructions to the relevant personnel for extracting the de-identified data.

Please note that the HREG office will not approve the request for a research project until ethics and governance requirements have been met.

Further information regarding Data Release Requests is available on the CONNECT page Data Governance.

Application forms 

Ethics Review Manager (ERM) 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, Associate Investigators, Heads of Supporting Departments and the Principal Investigator's Head of Department.
  • Note: List an institutional email address for correspondence – personal emails and phone numbers will not be accepted. Advice on creating a SSA form across different states can be found at National Mutual Acceptance.
  • Note: Associate Investigators are defined as members of the team at the study site that perform significant study-related procedures and make study-related decisions. They are designated and supervised by the site Principal Investigator.
• CVs:
  • Please submit Peter Mac site Principal Investigator and Associate Investigator CVs, if not already submitted within the last three years.
  • Please submit CVs in the following format: "SURNAME, Forename CV DATE"
• Good Clinical Practice (GCP):
  • For all interventional clinical research projects all investigators must provide evidence of current GCP training, if not submitted within the last three years.
  • Researchers on all other human research projects are strongly encouraged to undertake GCP training.
  • Please submit GCPs in the following format: "SURNAME, Forename GCP DATE"
• Standard Indemnity provided by a commercial sponsor (if commercially sponsored project). Find Peter Mac site contact details for use in Indemnities here.
• Insurance Certificate provided by a commercial sponsor (if commercially sponsored project).
• Agreements:
  • 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 Legal Office. Find Peter Mac site contact details for use in agreements here.
  • Data/Material Transfer Agreement/CTRA/MACH/Collaboration Agreement: Peter Mac PI/contact must email This email address is being protected from spambots. You need JavaScript enabled to view it..
• Radiation: Provide the radiation report or HREC Radiation Notification Letter 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 (for example, Protocol, Investigator Brochure, master PICF/s and any other master documents). 
• If using unapproved therapeutic goods: TGA Clinical Trial Notification (CTN) or TGA Clinical Trial Application (CTA), listing each site under review. CTN is an online form. Please include a PDF/screenshot of the filled in CTN for review (Peter Mac as sponsor projects please contact Clinical Research Development & Operations to fill out a CTN form This email address is being protected from spambots. You need JavaScript enabled to view it.). Find Peter Mac contact details for use in these documents.

Site specific documents  

Multi-site ethical review projects only, please also include site specific documents based on the ethically approved master documents, for example site-specific Participant Information and Consent Form (PICF) on Peter Mac letterhead (found on CONNECT). Find Peter Mac details for use in Participant Information Sheet and Consent Forms (PICF) 

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 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.

Investigator Training Requirements

All personnel involved in clinical research at Peter Mac must complete the below mandatory training:

*For personnel requiring GCP training for the first time, the full course certification is required.  Full course may be required for existing personnel at the request of the individual's manager, Research Integrity officer or CRGAC

** Please Note: Parkville Cancer Clinical Trials Unit (PCCTU) SOPs are inclusive of the National SOPs (Peter Mac Clinical Research SOPs) and hence all PCCTU Investigators and Staff only complete training on PCCTU SOPs

New and ongoing clinical trials are contingent upon you and your study team’s full completion of these additional mandatory training courses.

The policy is found in iPolicy (Conduct of Clinical Research Personnel), as well as the ‘quick links’ section on the Clinical Research page of Connect.