Conference Schedule
Understand how to effectively communicate the expectations and timing of a completeness review. Who should do the review and what are the most important factors they must check?
  • Understand the importance of timing and readability
  • Use technology for maximum integration
  • Explore completeness review from a resourcing and staffing perspective
Sustaining an inspection-ready TMF requires a comprehensive and sound approach, accounting for variables, and evaluating what went wrong. Are you prepared to craft a meaningful response other than having a CAPA to address findings?
  • Build a robust function QC process
  • Link quality management to the TMF Plan, which is a less frequently addressed approach
  • Implement a quality management system in TMF plan documentation for effective change
Patient perspectives collected before, during, and after a trial can help provide a more complete picture about patient priorities, trial outcomes, and the overall trial experience.
  • Identify key topics and methodology for patient insights collection at various trial stages
  • Explore the benefits and limitations of PROs, and how qualitative approaches can provide additional context to outcomes and endpoints
  • Learn the value of exit interviews and how they complement trial data
Develop a working partnership to appreciate the CRO’s experience. While teaching the CRO to understand your end game goals, you need to understand their own requirements and motivations as well.
  • Refine collaborative procedures with CROs
  • Maintain a constant state of inspection readiness while enhancing the relationship with your CRO
  • Establish proper training and support for inspections
Your current portfolio and existent quality review processes need to be evaluated for fit for purpose. This process involves defining your needs, optimal schedule, contributors, and documentation steps.
  • Prepare your teams to evaluate for “Accuracy and Completeness”
  • Track your eTMF improvements over time
  • Ensure quality review documentation
By following every update in eTMF reference model activities, you can better adapt to changes in artifact and sub artifacts. Hear about those and other configurations that affect the TMF such as users access, profiles and data dictionaries.
  • Organize eTMF systems with ease
  • Discuss the importance of artifacts/sub-artifacts in eTMF Systems
  • Align additional attribute configuration with your artifacts/sub-artifacts
  • Position assessments through time
Ensure timeliness so that all parties understand their role in the successful documentation of the clinical study. Only rigorous documentation can help preserve reliable data quality.
  • Adapt the eTMF for better clinical data management
  • Implement a stable clinical trial management process with your clinical team and the third-parties
Are you using your eTMF to its full capacity? Probably not. Take an in depth look at the technical improvements that can maximize your eTMF and increase your efficiencies to read data and automatically filing into the eTMF.
  • Align your Index/TOC with your eTMF and discuss the challenges that arise from that reconciliation
  • Work with your technical representative from implementation to maximize your eTMF
  • Hear new and exciting adaptations to your eTMF that most aren’t using or even considering
Effective corroboration with sites is imperative to the success of the TMF. Ensure all correspondence is meaningful and to the point.
  • Incompleteness challenges and solutions addressed regarding sites
  • Certify your sites contact log feature is properly implemented
  • Explore performance and compliance strategies with your site