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Case Report Form Design Module Three: Best Practices . Society for Clinical Data Management Online Course. : Best Practices for CRF Design. Design the CRF in parallel with the protocol Design CRFs with CDASH and SDTM in mind Be familiar with the current versions

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Case report form design module three best practices

Case Report Form DesignModule Three:Best Practices

Society for Clinical Data Management

Online Course


Best practices for crf design
: Best Practices for CRF Design

  • Design the CRF in parallel with the protocol

  • Design CRFs with CDASH and SDTM in mind

    • Be familiar with the current versions

    • Both are available for download at www.cdisc.org

  • Establish and use standards

  • Design the CRF with the primary safety and efficacy endpoints as main goal of data collection

    • Challenge other data, how will it be used?


Best practices for crf design1
: Best Practices for CRF Design

  • Design CRF using a collaborative cross-functional team process

    • Involve the site staff, clinical monitoring, clinical programming, and biostatistical teams for different perspectives on the data being collected

  • Design clear and concise questions, prompts and instructions

    • Include the relevant instruction from the CRF Completion Guidelines on the CRF page

      • Provide examples, e.g. DDMMMYYYY

    • Can the question be interpreted differently?


Best practices for crf design2
: Best Practices for CRF Design

  • Design the CRF to follow the data flow at the clinical site and per protocol specified order

    • Identify data that will be collected at a different location or different timepoint. Should it be collected on the CRF if it is being electronically provided?

  • Understand how the data is collected at the site


Best practices for crf design3
: Best Practices for CRF Design

  • Design the CRF to avoid referential and redundant data collection

    • Do not collect calculated fields!

  • Use data collection tools that minimize transcription and data transformation steps

  • Use data collection tools that minimize errors and queries (e.g., if collecting a numeric value that should always have a decimal precision of 2, put the correct number of boxes )


Best practices for crf design4
: Best Practices for CRF Design

  • Consistency:

    • Consistent look and feel to minimize confusion

    • Codelists should be used consistently ( e.g., Y/N – always in same order)

    • Consistent date and time formats

    • Keep data collection consistent between protocols for the same investigational product

  • User Testing:

    • Request non-DM team member to test the CRF


Best practices for crf design5
: Best Practices for CRF Design

  • Governance and Standards

    • Best Quality practices for organizational governance

    • Meeting frequencies

    • Control of the standards

      • Gatekeeper / Global Librarian

      • Updating standards

      • Access to standards

    • Build a user feedback mechanism into the CRF design and maintenance process

      Using best practices will improve data quality and save time with CRF design, use and modifications


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