Greater than Low Risk New Submissions
This page outlines the SCHN submission processes for Greater than Low Risk research ethics 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:
- EPCT Submission Guideline
- EPCT Intention to Submit Form (non-Device)
- EPCT Intention to Submit Form (Device)
- EPCT Submission Checklist
- EPCT Invoicing Authorisation Form
2021 Submission Closing Dates for Early Phase Clinical Trials
| Submission Closing Date
12noon SHARP | Combined SAC and HREC meetings |
| Monday, 25 January 2021 | Friday, 5 February 2021 |
| Monday, 22 February 2021 | Friday, 5 March 2021 |
| Monday, 29 March 2021 | Friday, 9 April 2021 |
| Tuesday, 27 April 2021 | Friday, 7 May 2021 |
| Monday, 24 May 2021 | Friday, 4 June 2021 |
| Monday, 21 June 2021 | Friday, 2 July 2021 |
| Monday, 26 July 2021 | Friday, 6 August 2021 |
| Monday, 23 August 2021 | Friday, 3 September 2021 |
| Monday, 20 September 2021 | Friday, 1 October 2021 |
| Monday, 25 October 2021 | Friday, 5 November 2021 |
Contact Details:
Clare Bayram, 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
2021 Submission Closing Dates for Greater than Low Risk Applications
| SUBMISSION CLOSING DATE 12pm SHARP | SAC MEETING
| HREC MEETING
|
| Monday 1 February 2021 | 18 February 2021 | 19 February 2021 |
| Monday 1 March 2021 | 18 March 2021 | 19 March 2021 |
| Tuesday 6 April 2021 | 22 April 2021 | 23 April 2021 |
| Monday 3 May 2021 | 20 May 2021 | 21 May 2021 |
| Monday 31 May 2021 | 17 June 2021 | 18 June 2021 |
| Monday 28 June 2021 | 15 July 2021 | 16 July 2021 |
| Monday 2 Aug 2021 | 19 August 2021 | 20 August 2021 |
| Monday 30 August 2021 | 16 September 2021 | 17 September 2021 |
| Monday 27 September 2021 | 14 October 2021 | 15 October 2021 |
| Monday 1 November 2021 | 18 November 2021 | 19 November 2021 |
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
Link to HREC Submission Closing Dates of other HRECs in Sydney Health Partners