Early Phase Clinical Trials
Mandatory pre-review process
Early Phase Clinical Trial (EPCT) applications have a mandatory pre-review process that must be initiated 4-6 weeks before the submission closing date.
The submission of the EPCT Intention to Submit Form indicates the start of the review process.
Early Phase Clinical Trial’s (EPCTs) definition includes all clinical trial phases up to but not including Phase II, including studies with any Phase I component.
Please see the EPCT HRECs Scheme Quick Reference Guide for a list of the types of clinical trials in the NSW Health EPCT HRECs Scheme.
Scope of SCHN EPCT HREC
The SCHN HREC operates as the NSW Health’s state-wide Early Phase Clinical Trials Human Research Ethics Committee (EPCT HREC) for paediatrics.
Age group within the scope of SCHN HREC involves:
- Children and young people under the age of 18; and,
- Combined paediatric and adult trials, involving children/adolescents (under the age of 16) and young adults (up to the age of 25).
Submission resources
- EPCT HRECs Quick Reference Guide
- EPCT submission guideline
- EPCT submission checklist
- EPCT intention to submit form - device
- EPCT intention to submit form - non-device
- EPCT invoicing authorisation form
Submission closing dates
2024 submission closing dates
| Submissions close at 12:00pm on the following dates | Combined SAC and SCHN HREC meeting dates |
|---|---|
| Monday, 22 January | Friday, 2 February |
| Monday, 19 February | Friday, 1 March |
| Monday, 2 April | Friday, 12 April |
| Monday, 22 April | Friday, 3 May |
| Monday, 27 May | Friday, 7 June |
| Monday, 24 June | Friday, 5 July |
| Monday, 22 July | Friday, 2 August |
| Monday, 26 August | Friday. 6 September |
| Monday, 23 September | Friday, 4 October |
| Monday, 21 October | Friday, 1 November |
*Scientific Advisory Committee
A December meeting will be held only if required.