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The Library Approach to Driving EDC Setup Efficiencies: A Case Study

Electronic data capture (EDC) systems are computerized systems designed for the collection of clinical trial data. The setup, validation and deployment of the electronic case report form (eCRF) may become an exhaustive affair when it is fully repeated for each new clinical study.

Efficiencies can be gained by recycling eCRF pages – and associated data validation rules (DVRs) – that were promoted from existing source studies to a library. User acceptance testing (UAT) documentation for “promoted” eCRF pages and DVRs is copied to the library, thus bypassing the need for additional design and UAT efforts when those eCRF pages and DVRs are released for new clinical studies. This promotion process is repeated with the aim of expanding the library based on the go-live of new clinical studies.

Essentially, the library is a powerful tool that can be used to standardize the setup of clinical trials and their data collection, reducing budgets and timelines. To demonstrate the library process, the webinar will present a case study including practical examples of challenges and situations in which the library could be used.

Agenda

The objective of this webinar is to demonstrate the benefit of having an EDC library.

  • Introduction
  • Library setup
  • Library update
  • Library usage
  • Case study recommendations
  • Conclusion
  • Future steps

Speaker

Jan De Cleir is a Project Director at SGS. In this function, he supports and participates in the business development, marketing and strategy process using his knowledge and experience of biometrics processes to develop innovative plans and approaches within this area.

Session Schedule

3:00 pm London (UK)
4:00 pm Paris (France)
11:00 am New York City (United States)

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