Amendments and Updated Documents

Researchers must use REGIS to submit   governance post-authorisations amendments (including progress reports, safety reports, CTRA amendments, insurance certificates, changes to local study personnel, First Patient In etc.)

NB: Where Ethics is being managed by REGIS the Annual Progress Reports should filter down to the NSW sites listed in REGIS. For sites outside NSW please submit through the relevant system in that jurisdiction.

NB: Where Ethics is outside of REGIS and is being managed in another jurisdiction, the HREC approved annual progress reports must be submitted to the sites under ‘Progress Report – External HREC milestone’

NB: If your milestone is not showing in your dashboard, please contact the approving Governance Officer and request for one to be created for the relevant milestone. 

Walk through videos for each of the above processes can be accessed on the REGIS QRG page https://regis.health.nsw.gov.au/how-to/  

Investigator Brochures

The only Investigator Brochure required by the Research Governance Officer is the one included within the original SSA application within REGIS.

Updated Investigator Brochures are for HREC review only and should not be submitted to the Research Governance Officer.

Amendment to Clinical Trial Agreements

Before submitting the documentation to the RGO please check that the Institution name, address and ABN number are correctly listed.

If incorrect please liaise with the sponsor and have the document corrected before submitting to the RGO.

1.     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

Please submit:

1.     A copy of the Amendment signed by both the Sponsor and the Investigator

2.     A cover letter detailing the reason for the amendment (such as Protocol Amendment, recruitment number changes, budget changes)
 

Updated Forms of Indemnity

The updated Form of Indemnity must always be submitted with a copy of the current Certificate of Insurance.