Research Support Services Updates: November 2020

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 & TimeTopics 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
Legal Documents

 

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
Informed Consent

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).



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