SESLHD is committed to developing a culture that values and promotes research, to building research capacity across the district and to engaging staff in research including clinical trials.
|South Eastern Sydney Local Health District
District Executive Unit, Level 4
The Sutherland Hospital & Community Health Service
Cnr the Kingsway and Kareena Road
CARINGBAH NSW 2229
|70 442 041 438
|Contact for notices
|Site Principal Investigator
Clinical Trial Agreements
External partners or sponsors?
Within your planning phase, the required agreements when conducting a study with external partners should be considered early in your project timeline. Only when all relevant documents and all relevant approvals have been collated (such as contingency worker status, data custodian approval etc), it is ready to be submitted within the SSA through REGIS. All signatures should be collected on agreements before submission and the Director of Research will be the last to sign the contract.
Types of agreements
Please see below the types of agreements that are processed within SESLHD Research Office within governance and signed by the Research Director on behalf of the health district are:
- Material Transfer Agreements (SESLHD MTA template - request via email)
- Standard forms of Indemnity (Medicines Australia Templates only)
- Service Level Agreements (SESLHD template – request via email)
- Multi-institutional Agreements (MIAs) and collaborative agreements
- Clinical Trial Research Agreements (Medicines Australia Templates only):
- CTRA standard
- CTRA CRO- contract research organisation acting as the local sponsor
- CTRA CRG - Collaborative or Coorporative Research Group (CRG) studies
- CTRA Phase 4 clinical trial (Medicines)
- CTRA Phase 4 clinical trial CRO (Medicines) contract research organisation acting as the Local Sponsor
- CTRA Guide
- Confidentiality agreements (CDAs, DOIs or NDAs)
- Form of Indemnity (Medicines Australia templates only)
- Form of Indemnity – HREC only (Medicines Australia templates only)
* Non-Clinical Trial Collaborative Research Agreement template can be found on: Forms and Templates Page.
Please ensure that the agreements have been partially executed and the SESLHD Research Director is the last to sign the agreement.