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we had a session last year but should we progress this discussion and what sites are collecting metrics and what do they need and find useful and how to easily collate the data. With National Governance Framework this is going to be a crucial area

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we had a session last year but should we progress this discussion and what sites are collecting metrics and what do they need and find useful and how to easily collate the data. With National Governance Framework this is going to be a crucial area

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As the past 4 years across the Globe were very difficult for many, what are some take away's that AUS and NZ have gathered to make Clinical Trials and overall patient experience within them more robust.

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Unlocking Knowledge: Exploring Factors Contributing to Site Learning and Recognizing Alternative Learning Pathways in Clinical Trials

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Unlocking Knowledge: Exploring Factors Contributing to Site Learning and Recognizing Alternative Learning Pathways in Clinical Trials

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Exploration of alternatives to traditional certified education and training. Value of workshops, webinars, conference attendance, partaking in working groups etc. Recognition of these as valid learning and career enhancing activities that should be provided/ funded by Institutions.

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During summit sites mention things Sponsor could be doing. GK wants to have some representatives gather towards end of summit or at the end, to identify some solutions we could work on together (eg easy wins)

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Revolutionizing Medicine: Exploring the Frontiers of Cell and Gene Therapy

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Revolutionizing Medicine: Exploring the Frontiers of Cell and Gene Therapy

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Do we need a session around what is different in a CAGT study? Many processes and considerations and high touch needed and continuous review of IP through whole process. Side effects of these newer agents. Not only cancer but coming to other areas.

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Definitely need to have this for sites. what considerations do sponsors and CROs need to consider when bringing technologies to a trial. Many times sponsor think it is easy but it is not at the site level. Consider all Australians do not have internet. Some do not have email some do not have iphone. The coverage in area may not be what sponsor has provided e.g. SIM

Need local phone support for helpdesks not just email and not overseas. CRAs need upskilling and understand how the technology works - they need more training. Must be discussed the use of tech at SSV. SIV too late. If CRA does not know then escalate to global team they will know what is to be used.

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Navigating Teletrials: Key Considerations for a Successful Remote Clinical Trial Experience

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Navigating Teletrials: Key Considerations for a Successful Remote Clinical Trial Experience

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Discussion with a panel of Teletrial experts on important things to consider when deciding to undertake a Teletrial or when debating whether to run the study as a single site or a Teletrial model. Early partnerships and discussions with RRR sites to foster better Teletrial set up prior to study selection.
Sponsors perspective on considering Teletrials for their studies.

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Unveiling Strategies: Recruiting Challenges and Solutions in Rare Pediatric Disease Clinical Trials

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Unveiling Strategies: Recruiting Challenges and Solutions in Rare Pediatric Disease Clinical Trials

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Tech Check: Examining Site Technology Assessments for Enhanced Clinical Trial Efficiency

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Tech Check: Examining Site Technology Assessments for Enhanced Clinical Trial Efficiency

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does the site have the capabilities to take on tech
is there some checklist
what questions do the site need to ask
its the how - training, budget, time, support
What are the skills needed?

proposed by Tam

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Do we have a session from A-CTEC about what they offer and also how can sites get easily accessible free education on important topics. How to make this wide ranging and where to store this information. Is that A-CTEC or others too.

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Do we have a session from A-CTEC about what they offer and also how can sites get easily accessible free education on important topics. How to make this wide ranging and where to store this information. Is that A-CTEC or others too.

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Thriving Independently: Insights from Self-Sustained Research Sites on Success and Sustainability

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Thriving Independently: Insights from Self-Sustained Research Sites on Success and Sustainability

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Engaging a panel of site personnel who run financially self-sustained and progressive sites; and learning from their experience

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Financial Navigation in Clinical Research: Site Leadership's Guide to Finance and Accounting Essentials

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Financial Navigation in Clinical Research: Site Leadership's Guide to Finance and Accounting Essentials

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Panel consisting of Finance expertise who can provide guidance and tips for good money management and forecasting for sites.

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Adaption To Innovation: Integrating Wearables and Emerging Technologies in Clinical Trials – Preparation and Special Considerations

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Adaption To Innovation: Integrating Wearables and Emerging Technologies in Clinical Trials – Preparation and Special Considerations

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Parallel Paths: Cultivating And Continually Improving a Dynamic Research Workforce for Parallel Clinical Trials

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Parallel Paths: Cultivating And Continually Improving a Dynamic Research Workforce for Parallel Clinical Trials

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Pharmacy
Finance
HR
Business Development/ Management
Operations
Quality Assurance
Education & Training
Administration

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Site Chronicles: Navigating Teletrials - Perspectives, Challenges, and Success Stories from the Front Lines

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Site Chronicles: Navigating Teletrials - Perspectives, Challenges, and Success Stories from the Front Lines

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Build on the experience as more sites and sponsors work on them

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Have representatives from TGA to present

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Mastering Medications: Best Practices in Pharmacy - Investigational Product Management for Clinical Trials

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Mastering Medications: Best Practices in Pharmacy - Investigational Product Management for Clinical Trials

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IP/ Devices management - enablers/ barriers; new norms; better preparing for trial related compounding.

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Navigating Limited Resources: Innovative Approaches to Funding and Budgeting for Rare Disease Trials with Limited Patient Populations

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Navigating Limited Resources: Innovative Approaches to Funding and Budgeting for Rare Disease Trials with Limited Patient Populations

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NOTE: Bring in NZ perspectives to Regulatory topics, specifically. 

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NOTE: Bring in NZ perspectives to Regulatory topics, specifically. 

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Diversity differences in AUS vs. NZ. How to manage those differences effectively.

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Diversity differences in AUS vs. NZ. How to manage those differences effectively.

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Building Bridges Under Pressure: Navigating and Sustaining Relationships Between Clinical Trial Sites and Industry Partners

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Building Bridges Under Pressure: Navigating and Sustaining Relationships Between Clinical Trial Sites and Industry Partners

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Fostering Growth: Empowering and Supporting New Clinical Trial Sites for Success

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Fostering Growth: Empowering and Supporting New Clinical Trial Sites for Success

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Guardians of Data: Navigating Cybersecurity in Clinical Trials – Addressing Data Transfer Concerns and Best Practices

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Guardians of Data: Navigating Cybersecurity in Clinical Trials – Addressing Data Transfer Concerns and Best Practices

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Behind the Scenes: Proactive Planning and Best Practices for Successful Site Inspections in Clinical Trials

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Behind the Scenes: Proactive Planning and Best Practices for Successful Site Inspections in Clinical Trials

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It would be great to share tools that sites are using to aid recruitment.

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Focus on the different eSource, eConsent, ePay providers,etc.

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Provide data/stats on how Australia compares to other countries in number and quality of clinical trials/data produced.

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consider patient with SAEs (see post-summit survey comment)

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For example, EMR, eISF and eSource have already been widely adopted in some
organizations and having them share their experience would be great.

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From Burnout to Balance: Cultivating Healthy Workplaces in Clinical Research and Strategies for Mitigation

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From Burnout to Balance: Cultivating Healthy Workplaces in Clinical Research and Strategies for Mitigation

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Assuring ANZ is seen on the global CT stage. Strategies for standing out

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Assuring ANZ is seen on the global CT stage. Strategies for standing out

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Elevating ANZ Visibility: Strategies for Ensuring a Prominent Presence on the Global Clinical Trials Stage

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Bridging Bureaucracy: Navigating the Challenges of Clinical Trials in Public Hospitals – Insights into Internal Processes, EC Submissions, Staffing, and Beyond

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Bridging Bureaucracy: Navigating the Challenges of Clinical Trials in Public Hospitals – Insights into Internal Processes, EC Submissions, Staffing, and Beyond

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It may be great to hear from those at public hospitals and the challenges that they faced with internal red tape, EC submission, staffing, etc.