Checklist - Private Sites SSA Submission
St Vincent’s Hospital Sydney (PRIVATE SITES ONLY)
St Vincent’s Hospital Private, The Mater Hospital, Victor Chang Cardiac Research Institute]
Checklist for Site Specific Assessment Submissions for private sites under SVH jurisdiction
- There is no submission deadline for SVH – Private Sites SSA review. Submissions are reviewed on a rolling basis in order of submission to the Research Office directly.
- Applications for private sites must be submitted, via the unique Research Office SSA – for Private Sites SSA form (irrespective on which system – ERM, REGIS, Online Forms the ethics approval has been processed)
- Please contact the Research office directly (SVHS.Research@svha.org.au or 02 8382 4960) if you intend to submit to any of the private sites listed above (SVHP, TMH, VCCRI) to obtain this unique SSA-For private sites form.
- A cover letter must be submitted with any SVH Private Sites SSA applications, listing ALL HREC submitted & approved documents, with correct version numbers and dates, to be used at the site.
- An application may be deemed ineligible if documentations as required and listed below are missing (meaning it would reflect an incomplete submission) or if signatures on the various declaration forms are missing.
- Ineligible applications may be returned and an email reply will be sent out to the PI.
- You MUST consult with any Head of any supporting department PRIOR to submitting your site specific application.
- All SVH-Private sites supporting departments must be listed on the SSA application.
- Head of Departments and Heads of Supporting Departments will need to separately provide evidence of support.
Site Specific Assessment Form NSW SSA
- Complete SSA Form
- The Principal Investigator must be an employee of the private site
- Include, into your submission, investigators who:
- will require access to the site for any research related purpose specific to the project;AND/OR
- will require access to confidential site information / data.
- The PI’s Head of Department and relevant heads of supporting departments must be listed on the SSA and must certify their support via sign offs on the respective declaration forms.
- If the Head of Department is an investigator, the appropriate Program Director / Manager has to certify
- If access to medical records is required, the appropriate medical records delegate from the respective Health Information Services Department must certify.
Ethics approval letter or email communication from Lead HREC (SVH or EXTERNAL) – the letter/email must list all documents to be used on site
- All HREC approval letters/emails including any subsequent approved amendments are required.
- The relevant Private site must be listed on the HREC approval letter as a participant site.
Short Curriculum Vitae for ALL site investigators
Site Specific Participant Information Sheet and Consent Form(s)
- Master PICF (final clean version) and Site Specific PICFs (tracked and clean) must be submitted.
- Ensure the correct Site Specific logo (SVHP, TMH, VCCRI) is included in the PICF (e.g. page 1 & consent/withdrawal sheets).
- Ensure the PICFs use the approved SVMHS Catholic wording with regard to pregnancy (if applicable). Please review our website for further information on the preferred wording options (https://www.svhs.org.au/research-education/research-office/standard-forms-templates-and-instructions-for-noted-documents ).
- Include SVH Research Office contact details are stated as per template on SVH RO website.
- For multicentre studies, the footer must have the HREC approved Master version AND the Site Specific version.
- The radiation statement needs to be the exact wording as per approved SVH radiation safety letter (if applicable).
Copies of ALL documents
- ALL documents approved by the Lead HREC (including SVH HREC) that will be used at the site.
- Master and Site Specific versions are required (e.g. posters, pamphlets…).
- HREA (copy only without signatures is acceptable); for all submissions prior to the 31 August 2017 and if applicable the NEAF instead of HREA
- SVH Radiation Safety Letter (if applicable).
- NOTE: The site specific logo (SVHP, TMH, VCCRI) needs to be inserted on ALL site specific documentation.
Itemised Study budget
- All research studies require a detailed budget outline. Minimum requirements as per the SVH budget template.
- Note: It is the responsibility of the Site Principal Investigator to ensure that sufficient resources (e.g. financial support) are in place to conduct the research.
- Note: The current infrastructure research levy on all research projects is 15% of the total amount.
Certificate of Insurance (minimum amount AUD 20 million per any one occurrence and in the annual aggregate) [IF APPLICABLE]
- Evidence of current insurance is required for all research studies (with external sponsors and/or collaborators) conducted at all sites under SVH jurisdiction.
- The certificate must be current and state ‘professional indemnity’ and ‘product liability’ (or equivalent) and includes clinical trials cover.
- An Australian legal entity must be listed as the insured on the certificate of currency of insurance.
- NOTE: A copy of the SVH insurance certificate is not required for investigator-initiated single SVH site projects.
Form of Indemnity [IF APPLICABLE]
Research Agreements [IF APPLICABLE]
- Medicines Australia: Standard / CRO / Collaborative / Phase 4 http://medicinesaustralia.com.au/issues-information/clinical-trials/clinical-trials-research-agreements/.
- The Medicines Australia footer must be included in the final version of the submitted contract.
- Please consult with the SVH RGO directly prior to submission.
- Please submit single-sided printed pages only.
- MTAA: Standard Clinical Investigational Agreement https://www.mtaa.org.au/clinical-investigations.
- Material Transfer Agreement (MTA)
- The St Vincent’s Research Office standard MTA must be used for samples originating from sites under the jurisdiction of St Vincent’s Research Office (to be requested from the RGO).
- Confidentiality Agreement (CA)
- Unless covered by another Research Agreement, all external research personnel with access to confidential information / data must sign a CA.
- Please ensure that the correct ABN and address is stated.
- Please submit 3 copies with original wet-ink signatures.
- All research related contracts must be submitted to the St Vincent’s Research Office.
Fee payment confirmation [IF APPLICABLE] https://svhs.org.au/home/research-education/research-office/hrec-fees-and-payments
NOTE: Honorary Appointment (HA) [IF APPLICABLE]
Working With Children Check (WWCC) [IF APPLICABLE]
Contact the Research Office if assistance is required
02 8382 4960 | SVHS.Research@svha.org.au | Translational Research Centre, 97-105 Boundary Street
Always refer to the Research Office website for the latest version of this checklist and any updates