Read the November 2020 updates from Monash Health’s Research Support Services.
Casual Research Coordinator Bank
Monash Health has recently set up a Research Coordinator Casual Bank, to support teams requiring leave back fill or short term support for clinical trials. The research teams utilising the bank are charged through their internal cost centre. Support for paediatric and adult trials and across specialities is available. If you are interested in accessing the Bureau, contact Deborah Dell on 9594 4605 or via email Deborah.dell@monashhealth.org
COVID-19 Foundation Research Funding
The COVID-19 research grant awardees have been announced. Read more about the awardees and their projects.
DocuSign Digital Signatures
Research Support Services is currently working with Sponsors, Monash Health Legal Counsel and IT Services to speed up the process of signing off on Agreements using DocuSign. This method of signing will be in line with change management being adopted by other organisations for the secure signing of legal documents. Secure electronic signing will have benefits in the speed of signing, paper reduction and resource efficiency by reducing manual handling and transport.
EMR Remote Monitoring
The “Remote Access to Electronic Medical Records (EMR) by Sponsors of Commercially Sponsored Clinical Trials” procedure is available on PROMPT. It is also available in the research governance section of the website.
A single web-based request workflow is being developed for Principal Investigators and Research Coordinators to arrange access for monitors.
Home Visit Protocol
Due to the COVID-19 pandemic, a “Home Visits to Clinical Trial Participants by Clinical Trial Staff” procedure is available on PROMPT. For any sponsor that requests a copy of the procedure, you may download it from PROMPT and provide the sponsor with a copy. Please note that this procedure is to satisfy the ethics and governance aspects of home visits and the procedure includes links to several Monash Health policies and procedures that must also be adhered to.
Low Risk Human Research Ethics and Human Research Ethics Committee submission and meeting dates for 2021
View the submission and meeting dates for Low Risk and Human Research Ethics Review in 2021.
Library News
Browzine is a new electronic bookshelf for journals, just implemented. It provides a browse-able e-shelf by subject or keyword, full text articles and the ability to set up your own account to create a personal bookshelf, save and share articles.
A new library guide for managers is now online – providing tips and resources on different aspects of teamwork, communication, managing & leading. Depending on your mood, timeframe, learning style, there are short/long form materials for listening, watching and reading:
BMJ Best Practice’s new feature “Comorbidities” is now live. Add comorbidities to an acute condition for an updated treatment plan. This tool covers 10 common, high-priority comorbidities that have the greatest potential for harm. Also see our video on setting up the BMJ mobile app.
Research Support Services On Site Presence and Planned Closures
Research Support Services are fully operational remotely. There is a limited on site presence, with two team members in the office Monday – Friday. All team members are available by telephone and email during normal business hours.
Research Support Services will be closed on the following dates:
Wednesday 23 December 2020 – Friday 01 January 2021 (re-opening Monday 04 January 2021)
Research Support Services Virtual Seminars
The Research Support Services 4 part seminar series program will held via zoom. The seminars will cover an overview of ethics and governance, guidelines, ethics submissions for all risk categories, Site Specific Applications and governance, as well as several main topics like informed consent, safety, post approval submissions, monitoring and a wide selection of associated topics. Please note the capacity for attendees is 100 but the presentation will be put on the Research Support Services web site at the conclusion of the series.
| Date & Time | Topics to be Covered |
| Thursday 29 October 2020
12.30 pm – 1.30 pm | Overview of Ethics and Governance Guidelines, Legislation, Polices, Procedures Human Research Ethics Applications Low Risk Applications – Quality Assurance https://us02web.zoom.us/j/89494009527?pwd=K29YYWNOTmsxV2xBbnNsdy9mSWhPZz09
Meeting ID: 894 9400 9527 Passcode: 920776 |
| Thursday
12 November 2020
12.30 pm – 1.45 pm
| Site Specific Assessment Applications Governance Supporting Departments Good Clinical Practice Training
https://us02web.zoom.us/j/89294836899?pwd=VytsdlRzUlRrUlo0cUxMRTBWTzkwZz09
Meeting ID: 892 9483 6899 Passcode: 279765 |
| Tuesday 24 November 2020 12.30 pm – 2.00 pm
| Study Site Master File Essential Documents Data, Privacy and Recruitment Witnesses, Interpreters, Incompetent Patients
https://us02web.zoom.us/j/82665006872?pwd=cXA0ODM3SVJvc3p6Z1FWWVZ0d0ZIdz09
Meeting ID: 826 6500 6872 Passcode: 002481 |
| Monday 30 November 2020 12.30 pm – 2.00 pm
| Post Approval Submissions HREC Amendments Safety Reporting Protocol Breaches – Protocol Deviations Post Approval Monitoring – Research Progress Reports – Audits Intellectual Property Supplementary Information https://us02web.zoom.us/j/86720721416?pwd=V2hkNVlUYU9qV0QwSWhkdENBc09ydz09
Meeting ID: 867 2072 1416 Passcode: 423386 |
Research Opportunities for Junior Clinical Staff
Research Support Services and Monash Doctors Workforce have compiled a list of areas and contact people, so that clinical staff with an interest in research may be able to easily access information on potential research opportunities.
Invoicing for studies under Shared Financial Arrangements with Monash University
Research Support Services (RSS) is changing its method of invoicing for projects financially administered by Monash University to align with the methods undertaken by each unit. That is, for post approval ethics and governance fees invoices will be sent to Monash University and not the sponsor.
The process will require each Unit is to Email a spreadsheet to research@monashhealth.org listing all studies where Monash University is the payee with the following columns:
Protocol No – RSS local Ref Number eg RES-20-0000-XXX – Coupa PO number – PI and/or Coordinator (optional) – Comments (in case you need to point out anything)
When a payment form is submitted to RSS for a study being financially administered by Monash University, the fee form needs to specify the following details at the end of the fee form – not the sponsor details (see example below).