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:
- EPCT Submission Guideline
- EPCT Intention to Submit Form (non-Device)
- EPCT Intention to Submit Form (Device)
- EPCT Submission Checklist
- EPCT Invoicing Authorisation Form
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