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Improving eSource Site Start-Up Practices.

Amy E Cramer1, Linda S King2, Michael T Buckley3

  • 1Johnson & Johnson Innovative Medicine.

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|June 3, 2024
PubMed
Summary
This summary is machine-generated.

Implementing electronic source (eSource) software in clinical trials improves data quality and reduces costs. Key challenges include identifying champions and agreeing on approaches, with solutions like FHIR standard adoption and common checklists facilitating scalable eSource implementation.

Keywords:
clinical researchclinical trialeSourceelectronic data captureelectronic health recordshealth information technology

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Area of Science:

  • Clinical Informatics
  • Health Data Management
  • Clinical Trial Operations

Background:

  • eSource software offers potential for enhanced data quality and reduced costs in clinical trials by directly copying electronic health record data into electronic case report forms.
  • Integrating eSource into multicenter clinical trial start-up procedures is crucial for wider adoption of these technologies.

Purpose of the Study:

  • To identify key steps, challenges, and solutions for eSource site start-up in multicenter clinical trials.
  • To analyze the impact of identified challenges and solutions on eSource implementation teams.

Main Methods:

  • A qualitative integrative analysis was performed to identify eSource site start-up components.
  • A value analysis was conducted to prioritize challenges and solutions based on their impact.

Main Results:

  • Participants identified 36 key steps, 11 challenges, and 14 solutions for eSource site start-up.
  • Top challenges included lack of a site eSource champion and disagreement on eSource approach.
  • Key solutions involved vendor acceptance of FHIR standard, standardized legal documents, and a common readiness checklist.

Conclusions:

  • eSource implementation in multicenter clinical trials presents a complex socio-technical challenge during site start-up.
  • The identified solutions offer foundational infrastructure for scalable eSource adoption in clinical research.