Design of Case Report Forms

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CRF Relationship to Protocol Protocol determines what data should be collected on the CRF All data must be collected on the CRF if specified in the protocol Data that will not be analyzed should not appear on the CRF Protocol Analysis Plan Describes Study Conduct •purpose •objectives •operational aspects Describes Analysis •data presentations •key endpoints •statistical methods Case Report Form Collects data to support the above CRF Development • Guidelines Collect data outlined in the protocol Collect data to support the analysis plan Collect data required by the regulatory agencies
CRF Development • Guidelines (con’t) Collect data with all users in mind Be clear and concise with your data questions Avoid duplication Request minimal free text responses Provide units to ensure comparable values Provide instructions to reduce misinterpretations CRF Development • Guidelines (con’t) Provide “choices” for questions where possible Use of “None” and “Not done” for assesments Collect data in a fashion that allows for the most efficient computerization Collect data and formats that provides for pooling across studies CRF book needs to be finalized and available before an investigator starts enrolling patients into a study Elements of the CRF • Three major parts: Header Safety related modules Efficacy related modules • Module block of specific questions • CRF module(s) make up a single CRF page • CRF Book series of CRF pages
Page 1: Design of Case Report Forms David W
Page 5 and 6: Creating Efficacy Modules • Follo
Page 7 and 8: Properly Designed CRF • Component
Page 9: CRF Completion Guidelines • Used

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