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Site Specific Documentation - requirements

All patient facing documents intended for use at HNELHD sites must be made into a site-specific document which is a copy of the HREC approved Master document and includes information relating to specific to the site at which the research is to be conducted.

All site documents must include:

  1. Appropriate site logo
  2. Local HNELHD Research Office Complaint details
  3. Local Principal Investigator contact details
  4. Must be named in accordance with HREC approval.
  5. Footer must include site version and master version (2 options below)
    1. Site Specific PICF Version x, dated Day Month Year (based on master Version x, dated Day Month Year)
    2. Master document name, Version Number and date; Site name, Document Name, Version number and date

Please remember:

  • If recruitment involves different participant groups, clearly label each Information Sheet accordingly differentiating between the different groups
  • The document name, the information in the footer and the filename should all match
  • If documents listed on your HREC approval letter are NOT intended for use within HNELHD, please advise the HNE Research Office via cover letter with your SSA submission in REGIS.
  • If you are unsure if you require a site-specific Document, please email HNELHD-ResearchOffice@health.nsw.gov.au