Research handbook

Research Governance Framework and Guidelines for Conducting Human Research at Epworth HealthCare

Research policy

This policy applies to any person conducting research involving Epworth patients, staff and/or resources.

The COVID-19 pandemic is a rapidly evolving situation and the response measures required to effectively manage the impact of the pandemic on our patients and clinical trials must adapt accordingly. When implementing our response measures, at all times the safety of our patients and staff are our highest priority. Please refer to the Epworth Research Coronavirus (COVID-19) Contingency Plan – 19 March 2020 (PDF, 528KB) for further details.

The registration of new research projects with the Research Development and Governance Unit (RDGU) is encouraged. Development and governance activities will still be undertaken, however projects will only receive governance authorisation once the restrictions on research activity have been lifted.

There may be clinical trials that warrant exemption from the current COVID-19 research restrictions as outlined in the Epworth Research Coronavirus (COVID-19) Contingency Plan such as those involving treatments for acute or life threatening health condition. If your upcoming project fits this category please complete the COVID-19 restriction research exemption form (DOC, 40KB) and submit with your registration request.

The Epworth Research Development and Governance Unit (RDGU) has implemented a clinical research quality management system (QMS) across all Epworth sites. Underpinning the QMS is a suite of Standard Operating Procedures (SOPs) to achieve at least minimum good clinical practice standards in clinical trials and other clinical research.

All researchers and support staff at Epworth are required to be familiar with the Epworth Research QMS Implementation and Maintenance Protocol (PDF, 624KB) and conduct research in accordance with all relevant SOPs.

Documentation of SOP training must be kept for all research staff. The below resources include a training curriculum and template log for this purpose.

Please note all individuals involved in the conduct of clinical trials under the Clinical Trial Notification scheme at Epworth (i.e. involving unapproved therapeutic goods) are required to complete and record their SOP training in SiteDocs. Please contact the Epworth RDGU should you require access to this system.

Please contact the RDGU for any queries or suggestions for improvements: [email protected]

Standard Operating Procedure (SOP) documents - Research