Submission of all Research including Clinical Trials

 For Clinical Trials of a Drug 

1.     REGIS SSA, signed electronically through REGIS by all the required Heads of Department:

a.     Where relevant: Department where the research is being conducted, Pharmacy, Radiology

2.     When the Principal 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.

3.     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 Version 1, d/m/y)

b.  Effective 17 September 2024, all clinical trials studies conducted in the SLHD will now require a new additional 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.

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

1.     HREA

2.     HREC approval

3.     All documents reviewed and approved by the HREC

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.

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 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 will need to be obtained from the Director of Medical Services.

Please submit the following via REGIS for the RGO to obtain the Chief Executive’s signature:

1.     A copy of the appropriate Clinical Trial Agreement (Pharmaceutical, Collaborative or CRO).

a.     This copy should be signed by the Sponsor and the Principal Investigator otherwise they will not be accepted.

b.    Only those Special Conditions approved by the NSW Ministry of Health Legal Branch and the South Eastern Border States are acceptable:

                                          i.    Please provide evidence of their approval with your CTRA.

2.     The institution's details should be entered as follows:

Name of Institution: Sydney Local Health District

Address: Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050

ABN: 17 520 269 052

3.     A copy of the Standard Medicines Australia Indemnity signed by the Sponsor.

4.     Current Certificate of Currency including:

a.    Cover of AUD$20 million for commercially sponsored research

b.    Cover of AUD$10 million for collaborative or co-operative research groups

c.     Must be in Australian Dollars

d.     Must state cover for clinical trials

e.     Must state an Australian Insurer’s name and Australian address

5.     The submission of the CTN is the responsibility of the Sponsor

For Clinical Trials of a Device

Submit as per Clinical Trial of a Drug instructions.

Please provide the following via REGIS for the RGO to obtain the Chief Executive’s signature:

1.     A copy of the appropriate Clinical Trial Agreement (Pharmaceutical, Collaborative or CRO)

a.     This copy should be signed by the Sponsor and the Principal Investigator otherwise they will not be accepted.

b.     Only those Special Conditions approved by the NSW Ministry of Health Legal Branch and the South Eastern Border States are acceptable:

                                          i.    Please provide evidence of their approval with your CTRA.

2.     The institution's details should be entered as follows:

Name of Institution: Sydney Local Health District

Address: Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050

ABN: 17 520 269 052

3.     A copy of the Standard Medicines Australia Indemnity signed by the Sponsor.

4.     Current Certificate of Currency including:

a.    Cover of AUD$20 million for commercially sponsored research

b.    Cover of AUD$10 million for collaborative or co-operative research groups

c.    Must be in Australian Dollars

d.    Must state cover for clinical trials

e.    Must state an Australian Insurer’s name and Australian address

5.     The submission of the CTN is the responsibility of the Sponsor

Investigator Initiated Clinical Trials

For Investigator-initiated clinical trials where the SLHD is the sponsor we require:

1.     CTN information - for the drug or device being used. The submission of the CTN to the TGA is the responsibility of the SLHD. The RGO is the nominated person to complete the submission to the TGA on-line. The RGO will liaise with the Principal Investigator during this process. The CTN Information Form is available on the website.

2.     FEE: The Investigator will be responsible for the submission fee to the TGA. After liaison with the RGO this can be either by credit card payment or the payment of an Invoice generated by the RGO and forwarded to the investigator.

All amendments should be submitted via REGIS (ensure all relevant documents are uploaded with amendment application).

Close-out notifications should be emailed directly to the A/Research Governance Officer: SLHD-ConcordEthics@health.nsw.gov.au