Case Report Form Design Module Three: Best Practices

1. Case Report Form DesignModule Three:Best Practices Society for Clinical Data Management Online Course

2. : 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?

3. : 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?

4. : 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

5. : 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 )

6. : 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

7. : 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