Research

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 research.directorate@svha.org.au. 

 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 Remote Monitoring is now optional, the Onsite Monitoring Application Form is no longer applicable.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 25^th 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.