Regulatory Guidance

  • FDA Supports Innovation in Clinical Trials with eConsent4:12

    FDA Supports Innovation in Clinical Trials with eConsent

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  • Understanding the EMA Oncology PRO Guideline Appendix – We Can Help!

    Understanding the EMA Oncology PRO Guideline Appendix – We Can Help!

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  • How Electronic Data Collection Helps Meet the FDA's Quality Guidelines3:05

    How Electronic Data Collection Helps Meet the FDA's Quality Guidelines

    Robert Murray explains the FDA’s five ALCOA principles for ensuring quality of clinical trial data, explaining how electronic data capture (eCOA) helps trial sponsors meet and exceed these guide-lines

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  • Recommendations on Evidence to Support Equivalence between Electronic and Paper-based Patient-Reported Outcomes

    Recommendations on Evidence to Support Equivalence between Electronic and Paper-based Patient-Reported Outcomes

    Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biologic agents, and

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  • Guidance for Industry Electronic Source Data in Clinical Investigations

    Guidance for Industry Electronic Source Data in Clinical Investigations

    This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data

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  • Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

    Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

    This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in appro

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  • Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications

    Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications

    The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and ri

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  • A Review of Patient Reported Outcome Labels in the U.S. - 2006-201355:34

    A Review of Patient Reported Outcome Labels in the U.S. - 2006-2013

    Ari Gnanasakthy discusses PRO label claims related to rare diseases, providing findings from a review of product labels and drug approval labels (DAPs) for orphan drugs approved between 2006 and 2013.

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  • COAs and Regulatory Labeling Claims: Information and Limitations36:34

    COAs and Regulatory Labeling Claims: Information and Limitations

    Andrea Murison of Mapi Research Trust joins Paul O’Donohoe to review a history of PROs and current trends in labeling claims, then discuss the impact of electronic data capture on PRO label claims.

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  • Generating the Evidence Required for Content Validity42:55

    Generating the Evidence Required for Content Validity

    Bonnie Teschendorf details the process of collecting PRO evidence to support content validity, covering aspects of instrument development, data coding, and analysis. Recorded February 18, 2011.

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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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  • ePRO Devices: Practical and Regulatory Considerations46:30

    ePRO Devices: Practical and Regulatory Considerations

    John Hutchin discusses current ePRO device technologies, highlighting practical and regulatory considerations needed to make better decisions during the ePRO deployment process. Recorded May 20, 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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