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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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