Migration and Validation

  • Validating Clinical Trial Data: Paper vs. eCOA2:50

    Validating Clinical Trial Data: Paper vs. eCOA

    Data integrity and validity have got to be the number one concern for anybody gathering data from subjects. Electronic Clinical Outcome (eCOA) solutions can help.

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  • 6 Key Considerations for Complete Paper to eCOA Migration57:51

    6 Key Considerations for Complete Paper to eCOA Migration

    Migration of a clinical study from paper to electronic requires technical, regulatory, and patient experience considerations. Follow these best practices to ensure an effective transition to eCOA.

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  • Paper to eCOA: A Guide to Migration

    Paper to eCOA: A Guide to Migration

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  • eCOA and Equivalence Testing: New Evidence from Meta-Analysis1:05:23

    eCOA and Equivalence Testing: New Evidence from Meta-Analysis

    Is equivalence testing necessary to establish comparability between electronic and paper-based clinical trial questionnaires? A meta-analysis of several years of equivalence tests provides insights.

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  • Migrating Paper Instruments to eCOA40:35

    Migrating Paper Instruments to eCOA

    Dr. Keith Meadows and Paul O’Donohoe discuss highlight important considerations and benefits of migrating a clinical study from paper to eCOA, with particular focus on a case study in diabetes.

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  • Clinical Outcomes Assessments: Considerations in Migration and Validation47:29

    Clinical Outcomes Assessments: Considerations in Migration and Validation

    Diane Wild and Kai Langel discuss clinical outcomes validation from the perspective of actual re-search, noting key terms and identifying challenges and best practices. Recorded January 19, 2012.

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  • COA Instrument Migration: Methodologies for Usability Testing and Cognitive Debriefing52:33

    COA Instrument Migration: Methodologies for Usability Testing and Cognitive Debriefing

    Paul O’Donohoe, Kai Langel and Diane Wild discuss eCOA instrument migration and validation processes such as usability testing, cognitive interviewing, and equivalency testing. Recorded June 21, 2012.

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  • Making the Transition from PRO to ePRO: An Industry Perspective45:52

    Making the Transition from PRO to ePRO: An Industry Perspective

    Members of an industry panel discuss ePRO deployment in clinical studies, including the lessons learned, best practices, as well as advantages of electronic over paper. Recorded November 19, 2009.

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  • FDA Guidance Compliance: Practical PRO/ePRO Instrument Equivalence Tips53:51

    FDA Guidance Compliance: Practical PRO/ePRO Instrument Equivalence Tips

    Diane Wild and Kai Langel discuss ePRO instrument development and validation within the scope of the FDA PRO guidance and outline CRF Health’s 4-step ePRO validation program. Recorded April 15, 2010.

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  • Instrument Validation, Psychometric Testing Including a Discussion of FDA Guidance & ISPOR48:21

    Instrument Validation, Psychometric Testing Including a Discussion of FDA Guidance & ISPOR

    Sonya Eremenco and William Lenderking report on ISPOR ePRO task force discussion, new pub-lication, and draft document, then introduce new instruments (EXACT-PRO and PROMIS). Rec-orded May 21, 2009.

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