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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. The site specific information must be named consistently and in accordance with the approval letters from HREC.
  5. The site specific information should include the following information in the footer as a minimum:
  6. Project Name, Protocol Version number and date
    Master document name, Version Number and date
    Site name, Document Name, Version number and date

NB: If recruitment involves different participant groups, clearly label each Information Sheet accordingly differentiating between the different groups as shown below

The document name, the information in the footer and the filename should all match

If there are master documents listed on your ethics approval letter that are NOT intended for use within HNELHD, please advise the HNE Research Office via cover letter with your SSA submission in REGIS.