New Governance Application

EPIC Electronic Medical Record (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 5-digit ERM (Ethics Review Manager) number to complete the survey. This is the five-digit 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 iPolicy as PIP6.1.1.7 What happens to information about you?

Application forms 

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 (Good Clinical Practice): For all interventional clinical research projects all investigators must provide evidence of current GCP (Good Clinical Practice) 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).

• 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.

• 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 (for example, 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 (Clinical Trials Notification).

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.

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.