St Vincent's is a major teaching, research and tertiary referral centre providing acute or chronic medical and surgical services, as well as clinical training.
Our commitment to innovative care is reflected by the passion for health and medical research evident across St Vincent’s campus and our partners, translating the findings of our scientists into meaningful improvements in clinical care. By participating in world-class research, we deliver hope to our patients and community and help determine the future of health care locally and globally.
We have established our innovative RESEARCH VALET® to assist with project submission for HREC review and also to speed the approval process. And we have sought to build productive relationships with industry to benefit both patients and clinicians with access to a wider range of clinical trials. Please click here for information regarding the RESEARCH VALET®.
COVID-19 Related Information
St Vincent's is working closely with the State Government’s Department of Health to help protect and keep safe our patients, visitors, staff and doctors from COVID-19. Our hospital remains open and fully functional, with the appropriate safeguards and containment precautions now in place. The Research Directorate and RGU are now activating SVHM's Flexible Working Policy as of March 2022. All ethics and governance submissions can only be accepted and processed via electronic formats as per our guideline. Our ethics committee meetings will continue to operate as per schedule via online video and phone access.
The Research Directorate has developed the "Plan for managing Clinical Trials in the setting of COVID19 disruption (18th March 2020, re-issued 10th July 2020)", for our staff, trial participants, research collaborators and clinical trials sponsors, see link for more details.
| SAGE - A new online portal for St Vincent's Application for Governance and Ethics
St Vincent’s Hospital Melbourne is implementing a new ethics review management system called St Vincent’s Application for Governance and Ethics (SAGE). SAGE aims to significantly assist the timely and efficient ethical and governance review of new and existing studies, by providing a one-stop portal for new applications, amendments, and other project updates.
Researchers are encouraged to use SAGE for all ethics/governance submissions going forward. The system will replace the existing ethics/governance submission process after a short grace period.
Please see the FAQ sheet and SAGE Resources for more information.
For further assistance, please contact the SAGE support team email@example.com.
|Addition of Clinical Trials Alerts on PAS for ALL Interventional Clinical Participants
As of 4th April 2022, a new generic Clinical Trials Alert has been added to the Patient Administration System (PAS) to ensure all interventional clinical trial participants are flagged on the hospital system.
This policy is aligned with the National Clinical Trials Governance Framework (NCTGF) which has been introduced as part of the national hospital standards and accreditation process. As part of this, we need to improve our ability to rapidly identify all participants in interventional clinical trials across the hospital and outpatient setting. This is important for patient/participant safety when they present to the hospital or health service for any episode of clinical care.
Each Department and their research staff will be responsible for adding the Clinical Trial Alert for each participant on the SVHM PAS when they are recruited to a study AND removing the alert when the participant completes the study, including any follow-up period. Please note that when the Clinical Trial Alert is removed at study completion, there will still be a past alert visible on the PAS system.
Please refer to Addition of Research Alert on PAS for more information. A quick guide is also available on our website.
The RGU will commence auditing the Clinical Trial Alerts on PAS from May 2022.
Onsite Monitoring Guidelines
As of 25th March 2022, SVHM is now allowing Onsite Monitoring. Remote Monitoring is now optional, the Onsite Monitoring Application Form is no longer applicable.
However, in line with the SVHM’s Guidance to reduce COVID-19 Exposure (available on the intranet), we strongly recommend the usage of tele/videoconferencing whenever practicable and possible. Updated Onsite-Monitoring guidelines can be found on Resources for Researchers.
Face to face meeting participants must:
- Not visit if unwell, and complete the COVID19 attestation online upon arrival here.
- Wear masks. If meeting is under 4 hours and not in a clinical area surgical masks can be worn, otherwise participants to wear N95 masks for the duration of the meeting.
- Check room size and maximum number of people that will fit with 1.5m spacing.
- Limit the meeting time by adhering to agenda and the scheduled finish time.
Should you choose to conduct remote monitoring, the Remote Source Data Monitoring Guidelines (2020) are still applicable. The study team must notify the RGU prior to the Interim Monitoring Visit that this is the method of remote monitoring they intend to use.
Breach Reporting Guidelines
As of 25th March 2022,SVHM RGU has updated our Breach Reporting Guidelines(2022), detailing non-serious breach, reportable vs non-reportable, and serious breach.
More definitions and examples of these breaches, and when and how to report them, can be found on Resources for Researchers.
For Ethics & Governance 03 9231 6970 email: firstname.lastname@example.org
For Research Valet 03 9231 6977 email: email@example.com
Dr Megan Robertson, Director of Research 03 9231 6974 email: firstname.lastname@example.org
Dr Tam Nguyen, Deputy Director of Research 03 9231 6980 email: email@example.com