Protected: Essential Briefing Webinar: ICH E8 and E6 (GCP) updates | A future forward approach to clinical trials
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NEW to Research Essentials!
NEW to Research Essentials! Personalised Medical Device Development EC.12 PRAXIS Australia is delighted to announce the launch of a new education model: Personalised Medical Device Development. This has been designed and built in partnership with The University of Melbourne, Epworth HealthCare and the ARC Training Centre for Medical Implant Technologies (CMIT). This unique training package […]
Special Announcement: PRAXIS CEO
Special Announcement: PRAXIS CEO The PRAXIS Australia Ltd Board today announced that Melanie Gentgall will step down from her role as founding CEO in late October, 2021. PRAXIS Chair, Terry McGuirk stated “over the last 7 years, Melanie has played a pivotal role in shaping PRAXIS Australia into the organisation you see today. Melanie’s ability […]
New Quality-by-Design Manual for Decentralised CTs
New from Association of Clinical Research Organizations (ACRO) “Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralized Clinical Trials.” ACRO has released a Quality By-Design Manual for Decentralized Trials, and Template for Risk Assessment Considerations. These tools have been designed to assist organisations to mitigate risk and to design and facilitate quality decentralised […]
Good Clinical Practice: Problem solving tricky and more common questions
Session 5 of the PRAXIS Plus+ Rapid Insights Series: Solution Finding Sessions Series This free webinar was a great opportunity for attendees to ask questions and seek advice on the day to day challenges they face in Clinical Trials practice. Some of the topics we covered included: What are the likely impacts to clinical […]
All Your Questions Answered: Introduction to Clinical Trials and Research
A candid conversation and Q & A with industry experts to learn about clinical trials. Topics covered: What are clinical trials The role of the nurse and midwife in clinical trials Regulatory and ethical considerations Interested in clinical trials? How to get involved. Presenters: Nicola Straiton RN, Project and Engagement Manager, Australian Clinical Trials Alliance […]
Consumer Involvement in Research: The role of researchers, HRECs and funders
PRAXIS Plus+ 2021: Research Ethics in Practice Webinar Series Session 3 – Consumer Involvement in Research: The role of researchers, HRECs and funders in promoting meaningful involvement of consumers. We had a great discussion last week with our panel of consumer involvement, industry and HREC experts, talking about ways to transform our intentions of involvement […]
Bellberry Limited Release 2020 Clinical Trial Activity Report
Bellberry 2020 #ClinicalTrial Activity report released at tonight’s Australian Clinical Trials Alliance #TrialoftheYear awards. Important landscape update on clinical trial activities in a year like no other from Australia’s largest single reviewer of trials conducted under a #CTN . #clinicaltrials #ICTD21 #HREC #ethicsreview
ICH E6 (R3) Principles released in draft form!
This represents a significant shift away from previous guidance. The renovated document is a principles based guideline that has quality deeply embedded in its message, in close alignment to what we can expect to see with ICH E8 (R2). Annexes 1 and 2 are not yet released, and public consultation has not yet begun. For […]
EU based i-CONSENT Project releases comprehensive informed consent toolkit
The document compiles a series of ethical recommendations, and a broader and more dynamic concept of consent, including: The gender perspective Consent with minors Fertility, pregnancy and breastfeeding Health literacy considerations Language, culture and ethnicity Designing consent with participants (co-design) A toolkit of resources, information sheets and use-case examples Link to the toolkit: https://www.linkedin.com/slink?code=gXnttsZ It’s […]
Face to Face is back!
New Workshop: SOPs as part of your clinical trials QMS The latest in our on-demand workshops, with spaces open for a small number of extra participants. This session is being conducted on behalf of QIMR Berghofer Medical Research Institute in Brisbane. May 5th, 2021 1200 – 1500pm $365pp plus GST What we’ll cover: What […]
The George Institute launches Join Us national register to save lives and improve the health of all Australians
Australia has world class health and medical researchers who have been responsible for many life changing breakthroughs that have benefitted the Australian and international community. But the ability to conduct this research in Australia depends on being able to recruit enough people into studies which can take months and sometimes hundreds of thousands of dollars […]