REGIS Checklist - Full HREC Submission

Document

Requirements

Signed cover letter addressed to HREC Executive Officer

Letter signed by the Principal Investigator (PI) or Coordinating Investigator (CI) for multi-centre projects.

List all sites for which SVH HREC approval is being sought and state whether they are public or private

List all documents submitted including versions/dates.

Human Research Ethics Application (HREA)(

HREA Form through REGIS

Study Protocol or Investigational Plan

(Electronic document titled “Protocol”)

Electronic copy of the Protocol must be sent as a searchable pdf or word document.

Submission of a protocol is mandatory; a template is available on the Research Office website under ‘standard forms’

Please use this rather than the template available through the HREA. Do not use version and date in the filename when uploading.

Study Protocol Summary

(Electronic document titled “Protocol Summary”)

Applies to Commercially Sponsored Projects only

Investigator Brochure

(Electronic document titled “IB_drug”)

Applicable for Commercially Sponsored Projects only Do not use version and date in the filename when uploading.

Participant Information Sheet & Consent Form(s) (PIS & CF)

(Electronic document titled

“PISCF_ name)

Submit all PIS&CFs in word format only

The use of NHMRC standard templates and wording (including privacy wording) is mandatory. Templates are accessible from the Research Office website under ‘standard forms’. Appropriate Catholic wording must be used in PISCF in interventional studies conducted on Catholic sites. Please refer to the Research Office website (standard forms).

If referring to drugs: use the ‘generic’ rather than the ‘brand’ name, include ‘witness to consent’ signature box on the consent page, do not use the term ‘de-identified’ (refer to National Statement 3.1, Element 4 for guidance on terminology), and do not use specific research office staff names in the contacts section of the form.

Insert the institutional logo (pages 1, consent and revocation of consent pages) for single centre projects and for multi-centre projects a master document must be submitted.

Radiation Safety Officer report

(if applicable – radiation exposure that is in addition to routine care)

(Electronic document titled:

“Radiation Safety Officer Report_site name”)

For SVH site/s: contact Radiation Safety Officer Dr Alessandra Malaroda

Email:  Alessandra.Malaroda@svha.org.au

Phone: (02) 8382 1807

Refer to Research Office website (Radiation Safety) for full submission requirements.

All other documents to be used in the study

(Electronic document titled:

“Document name”)

Examples include questionnaires (if not validated), advertisements, participant cards, letters of invitation, diaries, interview questions, telephone scripts all must have versions and dates

Medicines Australia Indemnity (HREC Review Only) on Australian Sponsor’s letterhead with ABN

Required if the study will not be conducted at St Vincent’s Public Hospital

The correct legal entity name for St Vincent’s Hospital:

St Vincent’s Hospital Sydney Limited

390 Victoria Street

Darlinghurst NSW 2010

ABN 77 054 038 872

Therapeutic Goods Administration Electronic Clinical Trial Notification (CTN) or Electronic Clinical Trial Exemption (CTX) form, if

applicable

For SVH-sponsored studies: The Research Office is responsible for the submission of eCTN/CTX forms to the TGA (i.e. individual investigators are not permitted to do this). Please submit an eCTN details form (available on the Research Office website under ‘standard forms’)

Fee payment confirmation

Please complete payment (if required) at:

https://svhs.org.au/home/research-education/research-office/hrec-fees-and-payments

Your submission is not valid unless payment confirmation is attached.