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