REGIS Checklist - SSA or LNRSSA Submission

St Vincent's Hospital Sydney (Public Only) - Checklist for Site Specific Assessment Submissions (SVHN SSA) - REGIS

Submission Instructions
  • There is no submission deadline for SVHN SSA review. Submissions are reviewed on a rolling basis in order of submission via REGIS.
  • Applications must be submitted, via REGIS system https://regis.health.nsw.gov.au/. Please refer to the relevant Quick Reference Guides for Research Applicants on the website for information about making a submission via REGIS.
  • A cover letter must be submitted with any SVHN SSA applications, listing  ALL HREC submitted & approved documents, with correct version numbers and dates, to be used at the site.
  • Ineligible applications may be returned and an automatic 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 via REGIS.
  • All SVHN supporting departments must be listed on the REGIS – SSA application.
  • Head of Departments and Heads of Supporting Departments will need to separately log onto REGIS to provide evidence of support.

Currently the St Vincent’s Hospital Research Office reviews SSA submissions under the REGIS scheme for the St Vincent’s Hospital Sydney.

Site Specific Assessment Form NSW SSA

  • Complete SSA Form in REGIS
  • The Principal Investigator must be an employee of the SVH 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 of the study via REGIS.They will receive an email requesting this however please note that Heads of Department and heads of supporting departments must be approached to secure study support well in advance of certification being requested on REGIS.You will be unable to submit the SSA until the Head of Department of the PI and the heads of supporting departments have clicked the certify button on their side.
    - 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 SVH Health Information Services Department must certify.

Ethics approval letter from Lead HREC (SVH or EXTERNAL) – the letter must list all documents to be used on site

  • All HREC approval letters including any subsequent approved amendments are required.
  • The relevant SVH 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 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).
  • 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
  • SVH Radiation Safety Letter (if applicable).
  • NOTE: The site specific logo 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)

  • 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

Research Agreements

  • 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)

  • Required for all external investigators & all internal and external students.
  • Please consult with the SVH RGO directly if unclear.

Working With Children Check (WWCC)

 

Contact the Research Office if assistance is required

]8382 4960 | SVHS.Research@svha.org.au | Translational Research Centre, 97-105 Boundary Street