Research Compliance Newsletter - March 2021 Edition
Team update
Welcome back, Dominique! Our Research Governance Officer, Dominique Williams, has returned from maternity leave and is in catch-up mode, learning about changes made in the last year. It’s great to have you back, Dom!
Good luck, Jade! Our Research Governance Officer, Jade-Leigh Moore, has just begun maternity leave. We wish Jade all the best and we look forward to her return next year. We will have a new team member filling Jade’s role within the next few weeks.
As we are reducing our working from home (WFH) days, we have had to spread out a little. Our Laboratory Compliance and Biosafety Officer, Corinne, and Project Officer, Ruth, have relocated to Office 283, which is on the southern side of Level 2 Aubigny Place, almost opposite the print room.
Our illustrious leader, Julie, presented at a National Congress on Food and Dining in Aged Care, in Sydney this month. Julie is an internationally recognised leader in the field of feeding and swallowing disorders (dysphagia) and is often asked to speak on these subjects at conferences. Well done, Julie!
Important!
Internet Explorer (IE) is no longer supported by Microsoft. It has been replaced by Microsoft Edge. Please use a browser other than IE when working in ERM, as problems can occur (e.g. screens hanging, forms don’t save).
Helpful hints and hot tips
When submitting your Investigator’s Brochure for review, please submit the tracked change version only. There is no need to submit both the clean and tracked versions of the document. This will help to reduce data storage and duplication of documents in ERM, reducing effort and costs for us all. Every little bit helps!
“Validation”—What does it mean? HREC submissions are reviewed to ensure (a) they are complete, (b) they have all necessary documents uploaded, and (c) that the information included in the application is sufficient for the Ethics Committee to review it. If you receive a ‘validation’ request, our HREC Liaison Officer will have provided you with the information that you need to provide for your application to be reviewed. Please don’t hesitate to contact our HREC Liaison Officer, Jodie Savini, on research.ethics@mater.uq.edu.au with any queries.
General News
Clinical Trial Approval (CTA) Scheme: The Therapeutic Goods Administration (TGA) has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme. The accompanying Clinical Trial Notification (CTN) scheme remains unchanged. Further information can be found on the TGA website.
Bellberry HREC form: In August last year Bellberry Human Research Ethics Committees introduced a new form, Organisational Verification of Personnel Form (BA F2.1.3), which is to be signed by an authorised representative from the organisation/site with which you are registering.
At Mater the authorised representative will be the following:
- Prof Maher Gandhi, Executive Director Mater Research to sign
- In Prof Gandhi’s absence, Emily Bailey, Director of Operations, to sign
- If both of the above are unavailable, Prof Allison Pettit, Director of Biomedical Research, to sign.
Please liaise with Alex Judge, Prof. Gandhi’s EA, to arrange a time for signatures.
Reminders
The 2021 HREC meeting dates are now available on the Ethics and Governance website.
Requesting Datasets: To ensure your requests to DTI for access to data in clinical records are actioned promptly, remember to include a copy of the Research Governance authorisation letter with your request. Data will not be released without this letter.
Monitoring Update
As our Monitoring Officer, Jade, is now on leave, we have advertised for a locum and hope to have a new officer commencing in the next few weeks to continue this important work.
Agreements Update
The Agreements Office is currently experiencing an unprecedented volume of agreement and contract requirements. We are using internal processes to determine priority. Please ensure you respond promptly to any queries from the Agreements Officer to keep your agreement moving. Emails are being monitored, so please continue to send requests this way. Additional short-term support to the Agreements Office has been approved and will commence in mid-March.