Service Features
The Research Directorate aims to make St Vincent’s a premier and preferred site to conduct sponsored clinical trials across a broad range of disciplines.
To improve support for sponsors, researchers and companies, the Research Directorate is proud to announce the Research Valet Service.
Valet includes full HREC submission preparation and liaison throughout the submission and approval process. St Vincent’s Hospital Melbourne is not required to be a participating site to utilise this service.
Download brochure| Valet® Fee (AUD) | $4,500 +GST |
|---|---|
| Service Provision | Full |
| Complete preparation & customisation of all ethics documentation: - PICF Master - HREA & distribution of site SSAs - Victorian Specific Module |
|
| Single point of contact for ethics and HREC liaison | |
| Coordination of essential documentation | |
| Distribution of approved documents to CRO Sponsor/Sites as required | |
| Concurrent Ethics & Governance review and approval (for SVHM only) | |
| Submission acknowledgment from HREC Secretary | |
| Committee review acknowledgment/decision within two business days of meeting | |
| Ethics outcome within 30 days |
- Single point of access for all regulatory advice for Australia
- Speed start-up time for Australian clinical trials (PH I-IV)
- Ethics outcomes within 30 days of committee meeting
- Start-up to full study management options
- Ethics approval from single HREC for all Australian states (except NT)
- St Vincent’s Hospital not required to be a participating site
Research Valet®
Lead Site Management
St Vincent’s Hospital Melbourne (SVHM) Research Directorate is pleased to offer Research Valet® post approval management services that facilitates all post approval project submission and ongoing ethics management where SVHM is the reviewing HREC.
To improve support for sponsors, researchers and companies, the Research Directorate is proud to announce the Research Valet Service.
Valet includes full HREC submission preparation and liaison throughout the submission and approval process. St Vincent’s Hospital Melbourne is not required to be a participating site to utilise this service.
| Post Approval Management | Cost |
|---|---|
| Major amendment fee (IB, Protocol submission with significant additions to ICF, addition of sites exceeding four sites) | $800 |
| Intermediate amendment fee (IB, Protocol submission with/without minor updates to ICF) | $600 |
| Minor amendment fee (Administrative documents) | $350 |
| Submission of documents for HREC email acknowledgment | $200 |
*Hardcopies to be provided by sponsor
Research Valet®
St Vincent’s
The key feature of this unique service is close communication between sponsors/researchers and the Research Valet team at each step of the process.
Dr Megan Robertson, Director of Research
As a current clinician (ICU) and over 10 years as Research Director in both the public and private sector, Megan has focused on facilitating research and embedding clinical research as a core component of clinical care. Her clinical knowledge and experience running clinical trials at the bedside provides a deep understanding of the trial process and the requirements for effective and efficient governance.
Sponsors or researchers will receive study outcome within 30 days of HREC meeting (except Phase 1 studies), and governance approvals will be targeted at seven days after submission of all required documentation.
