Greater than Low Risk New Submissions

This page outlines the SCHN submission processes for Greater than Low Risk applications. Please carefully read the submission guidelines when preparing your ethics applications, and contact the Research Ethics Office if you have any questions.

Early Phase Clinical Trials 

The Sydney Children’s Hospitals Network HREC operates as the NSW Health’s statewide Early Phase Clinical Trials HREC for paediatrics.  

Age group within the scope of Sydney Children's Hospitals Network HREC

  • Trials involving only children and young people under the age of 18; and 
  • Combined paediatric and adult trials involving children and young people under the age of 16 and young adults up to the age of 25. 

Definitions - Early Phase Clinical Trials 

Early phase clinical trial definition includes all clinical trial phases up to but not including Phase II, including studies with any Phase I component. Please refer to the following Quick Reference Guide for a list of the types of clinical trials covered by this scheme: 

Submission Guidelines 

All applications must be submitted as per the following submission guidelines:

 

2020 Closing Dates for Early Phase Clinical Trials 

Submission Closing Date

 12noon SHARP

Combined SAC and HREC meetings

Tuesday, 28 January 2020

(delayed due to Australia day)

Friday, 7 February 2020

Monday, 24 February 2020

Friday, 6 March 2020

Monday, 23 March 2020

Friday, 3 April 2020

Monday, 20 April 2020

Friday, 1 May 2020

Monday, 25 May 2020

Friday, 5 June 2020

Monday, 22 June 2020

Friday, 3 July 2020

Monday, 27 July 2020

Friday, 7 August 2020

Monday, 24 August 2020

Friday, 4 September 2020

Monday, 21 September 2020

Friday, 2 October 2020

Monday, 26 October 2020

Friday, 6 November 2020

 

Contact Details: 

Melinda Giles, EPCTs Research Ethics Officer

Phone: (02) 9845 3105

Email:SCHN-Ethics@health.nsw.gov.au 

Link to more information about the NSW Health Early Phase Clinical Trials HREC Scheme: https://www.medicalresearch.nsw.gov.au/early-phase-clinical-trials/

All Other Greater than Low Risk Applications 

All other greater than low risk applications must be submitted as per the following submission guidelines:

REGIS - Greater than Low Risk Submission Guideline

REGIS - Greater than Low Risk Submission Checklist

 2020 Closing Dates for Other Greater than Low Risk Applications 

SUBMISSION CLOSING DATE

12pm SHARP

SAC MEETING

 

HREC MEETING

 

Monday 3 February 2020

20 February 2020

21 February 2020

Monday 2 March 2020

19 March 2020

20 March 2020

Monday 6 April 2020

23 April 2020 

(delayed due to Easter)

24 April 2020 

(delayed due to Easter)

Monday 4 May 2020

21 May 2020

22 May 2020

Monday 1 June 2020

18 June 2020

19 June 2020

Monday 29 June 2020

16 July 2020

17 July 2020

Monday 3 Aug 2019

20 August 2020

21 August 2020

Monday 31 August 2020

17 September 2020

18 September 2020

Monday 28 September 2020

15 October 2020

16 October 2020

Monday 2 November 2020

19 November 2020

20 November 2020

 

Contact Details: 

Email:SCHN-Ethics@health.nsw.gov.au 

Forms, Templates & Resources Specific to Greater than Low Risk Applications

SPIRIT Drug/device protocol template – mandatory for investigator initiated studies

SPIRIT Non drug device protocol – mandatory for investigator initiated studies

Peer Reviewer Report Form - V1 - August 2017

Booking an appointment with the CHW Biostatistician

CHW Radiation Safety Report Application Form

SCH Radiation Safety Report Application Form

Link to Consent Templates & Resources

Link to Invoicing Authorisation Forms

Link to other relevant resources and templates