Checklist for Site Specific Assessment submissions to the Research Governance Officer
Site Specific Assessments (SSA) can be submitted before or after receiving Ethics approval, however both submissions are encouraged to be done in parallel.
Please include 1 copy of each of the documents submitted for Research Ethics Approval and 1 original of the following documents:
Cover Letter: Outline if study has been or is being considered by the Human Research Ethics Committee (HREC) Identify if HREC approval has been granted (include date) or is pending If available, include the HREC reference number List all documents enclosed
Site Specific Assessment Form (SSA) – www.ethicsform.org/au Signed and dated by ALL investigators named in the SSA Signed by the relevant ISLHD Head(s) of Department(s) – Principal Investigators who are Heads of Department must not sign their own SSA applications but must obtain the signature of their direct manager. Signed by relevant ISLHD Head(s) of Supporting Department(s) (eg. Pharmacy if dispensing drugs) (if applicable) Signed by Data Provision (if applicable)
Documents to be included with the SSA submission: Short CV for all Investigators (Principal and Associate) named in the SSA form Site Specific Participant Information Sheet and Consent Form (must include the ISLHD logo and each page must have the date and version number in the footer) Letter of approval from the HREC HREC Amendment Approval Letters (if applicable) National Ethics Application Form (NEAF) or Low/Negligible Risk Ethics Application form (LNR) Protocol Master Participant Information Sheet and Consent Form (each page must have the date and version number in the footer) Advertisements, patient diaries, etc Investigator Brochure (if applicable) Radiation Safety Approval (if applicable) Study budget summary completed and signed by the ISLHD Cost Centre Manager
ISLHD OPS F 340 REVISION 0 September 2013 Page 1 of 2
Clinical Trials Clinical Trial Notification (CTN) Form
Pharmaceutical/Medical Device Industry Sponsored Studies Medicines Australia Form of Indemnity on Australian company letterhead (3 originals) (http://medicinesaustralia.com.au/issues-information/clinical-trials/indemity-and- compensation-guidelines/)