Agenda at a Glance

• what is risk?
• A risk-based approach: benefits
• Risk based approach for quality in documentation
• A risk based approach for implementing eTMF

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• Establishing a robust TMF Foundation to support the CRO / Sponsor Relationship.
• Review of practical engagement tools for quality and transparent oversight
• Use  of shared metrics to monitor the process and deliverables to support continual improvement

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• Impact of a governance structure that incorporates metrics and monitoring
• Review of technology and impact of oversight with data
• Practical usage of your eTMF for monitoring to ensure inspection readiness
• Best practices and resources need to ensure a compliant and high performing collaboration 

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• Impact of your current RBM process and redefining it to strategically ensure trial success
• Developing a successfully RBM strategy for sites and CROs
• Impact on a paperless trial
• Reporting on KPIs and quality metrics

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• Overview of defining a GCP framework
• Review of ICH GCP R2
• Utilize your framework to increase oversight and inspection readiness

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• Overview on emerging technologies and the next generation of eTMFs
• Review of AI impact
• Improve quality through technology
• Practical considerations for eTMF System Implementation

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• Utilize the TMF management plan to guide deliverables and oversight
• Ensure SOPs align with technology
• Review the eTMF oversight and management plan and sampling eTMF for QC

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• Reviewing MHRA inspection findings over a four year period
• Impact and potential causes of these finding
• Utilizing past findings to improve Quality within your TMF process

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• Describe the role of continuous improvement in management of documentation/Trial Master File

• Develop Key Quality Indicators to identify issues early

• Explain how to optimize your operations through evaluation of Key Quality Indicator trends

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• Identifying needs vs wants
• Getting the most out of your resources
• Targeting pain points

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• Develop a proper data integrity checklist
• Review key principles of data integrity and ensure a audit trail and validations

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• Identify all critical aspects of an inspection to ensure your team is prepared
• Review of quality responsibilities
• Preparing and presenting critical documentation
• Look back at mock inspection results to prepare for your inspection

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• Overview of the role a site, CRO, and sponsor has on quality
• Impact of a clinical quality management system impact on process, procedures, and responsibilities
• Creating a quality culture and its impact on inspection readiness

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