Section 2: For projects where ethics approval was not undertaken by the RMH HREC

Where the RMH HREC is not the HREC responsible for the ethical review and approval, provide a copy of all ethics documentation relevant to the RMH site in the Site Specific application:

• The ethics approval letter
• All ethics amendment letters (if any)
• All ethically approved HREC documents relevant to the RMH site as listed on the approval letter(s) such as, but not limited to, the
  • Protocol
  • Investigator Brochure
  • Participant information and consent form
  • Participant cards
  • Approved HREA
  • Victorian Specific Module
  • Ionising radiation documentation
  • Questionnaires
• In addition, provide a list of documents that have not been submitted where you have determined they are not relevant to the RMH site. Providing this list will mean that our staff will know that we do not need to ask for them.