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Minimizing Regulatory Risks with ALCOA during Oncology Studies
FDA Supports Innovation in Clinical Trials with eConsent
Understanding the EMA Oncology PRO Guideline Appendix – We Can Help!
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
Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-based Patient-Reported Outcome (PRO) Meas
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
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
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
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
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.
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.
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.
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.
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.
Instrument Validation, Psychometric Testing Including a Discussion of FDA Guidance & ISPOR