Governance

Submission of SSA via REGIS

HAVE YOU RECEIVED ETHICS APPROVAL? IF NOT PLEASE CLICK ON THIS LINK:

CRGH HREC: https://www.slhd.nsw.gov.au/concord/ethics/ethicshowto.html

RPAH HREC: https://www.slhd.nsw.gov.au/rpa/research/ethicshowto.html

NB: All research personnel should have a REGIS account as all site authorisation documentation is sent via REGIS.

General Research/Non-clinical trials

The following documentation must be completed on-line through REGIS:

1. When the lead HREC is in NSW, the Principal Investigator (PI) can commence filling in the SSA in REGIS once:

(i) the Project Registration (the first step in initiating a research project in REGIS) has been completed; and

(ii) the HREA form has been submitted in REGIS.

When the lead HREC is in NSW, the Principal Investigator (PI) can commence filling in the SSA in REGIS once:

(i) the Project Registration has been completed; and

(ii) ethics approval has been granted

2. The PI requests declarations from Heads of Department in Part C of the SSA. In this section, all departments/locations whose resources are needed for the research at SLHD Hospitals must be identified. Resources include but are not limited to staff time, use of facilities, services or equipment, access to data/records. Any relevant Head of Departments must be consulted before the SSA is submitted.

3. Each HOD listed in Part C of the SSA will receive a system-generated e-mail which will allow them to indicate their decision to support or not and if there are any additional resources required. Declaration of support must be provided by each Head of Department, including the Head of the PI’s department. When a local Investigator is also the Head of Department please indicate in the SSA application that a signature will need to be obtained from the Director of Medical Services as the Director of Medical Services can be nominated in this instance.

4. Site versions of the approved Participant Information Sheets and Consent Forms and any other documents to be made site specific (such as Flyers, Advertisements, Diaries) must be uploaded into REGIS

What should the local Participant Information Sheet and Consent Form (PISCF) contain?

Non-clinical trial studies: The wording of the local Participant Information Sheet and Consent Form (PISCF) should be the same as that approved by the lead HREC for the Master PISCF. A tracked local Participant Information Sheet based on a clean Master Participant Information Sheet should be provided and must contain the following information:

Name and contact details of the [CRGH][RPAH] investigator.
Retain the name and contact details of the lead HREC.
A statement which reads: “The conduct of this study at [RPA] [Concord] [Canterbury] [Balmain] Hospital has been authorised by the Sydney Local Health District. Any person with concerns or complaints about the conduct of this study may contact the Research Governance Officer on [CRGH -02 9767 5622] or [RPA 9515 7899] and quote protocol number 2021/STExxxxx”.
A footer which reads “[[RPA] CRGH] Version x dated xx/xx/20xx based on Master Version x dated xx/xx/20xx”.
If relevant: Recommended radiation safety risk wording made by the local Radiation Safety Officer (RSO). For more information on radiation please see our website.

Clinical trial studies:

Further to the above and to ensure clinical trial participants have the opportunity to provide direct, comprehensive and timely feedback about their experiences specific to clinical trials, a Clinical Trial Patient Reported Experience Measures questionnaire has been developed by the SLHD Research Support team.
Effective 17 September 2024, all clinical trials studies conducted in the SLHD will now require an additional new statement, and a QR Code, to be added to the local Participant Information Statement prior to authorisation. Refer to the attached for further information and instructions on how to include the PREMs survey in the documents.

HREC within NSW/ACT: For any research applications where the HREC is within NSW/ACT, all ethics documentation will be held within REGIS including the HREA and HREC approval. If the ethics application was submitted and approved through a NSW/ACT HREC then the approved documents will be automatically shared with the SSA submission.

Interstate HREC under NMA: As other states do not use REGIS the following documents must be uploaded into REGIS when you complete your SSA:

HREA
HREC approval
All documents reviewed and approved by the HREC
Site versions of the approved Participant Information Sheets and Consent Forms and any other documents to be made site specific (such as Flyers, Advertisements, Diaries) must be uploaded into REGIS.

a. A site version is created by retaining the Master version and date in the document footer and adding beneath it the site name, version and date (RPAH/CRGH etc. Version 1, d/m/y)

1. NB: The interstate co-ordinating investigator must have a REGIS account as their details are requested when completing the project identification within REGIS.

2. When the Principal Investigator is also the Head of Department please indicate in the SSA application that a signature willl need to be obtained from the Director of Medical Services.

All study correspondence after you gain site authorisation should be submitted via REGIS. No hard copies are to be sent to the Research Governance Officer. Please see Section on Amendments and Updated Documents.

Detailed information is available in the following REGIS Quick Reference Guides: https://regis.health.nsw.gov.au/how-to/

Site Application - Completing, Requesting Support and Submitting https://www.youtube.com/watch?v=kYdJM4JCO7U&feature=youtu.be

Create a New Site Application

Note: Use this guide when project registration has already been submitted and:

·You need to create a new/additional site application before NSW/ACT ethics has been approved OR
When a non-NSW/ACT HREC has approved a new NSW site