Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium (May 18, 2017)
This webinar provides a recommended framework for the selection and evaluation of wearable devices and their measurements for use in regulatory trials to support labeling claims. The webinar will also address the essential properties of fit-for-purpose wearables and the activities required to establish clinical endpoints derived from data collected with wearable devices.
Presenters: Bill Byrom, PhD (ICON) and Chris Watson, PhD (ERT)
Considerations for Requiring Subjects to Respond to PRO Instruments Collected Electronically (February 28, 2017)
This webinar provides an overview of specific considerations related to allowing subjects to opt out of responding to individual items when PRO data collection is electronic as well as the relevance to other types of electronic clinical outcome assessments.
Presenter: Paul O’Donohoe, MS (CRF Health)
Ensuring Equivalence of Electronic and Paper Administration of Patient-Reported Outcome Measures (September 29, 2016)
This webinar provides an overview of scientific and regulatory considerations when migrating paper-based patient-reported outcome (PRO) measures to electronic modes of data collection.
Presenters: Paul O’Donohoe, MS (CRF Health) and Willie Muehlhausen, DVM (ICON)
This webinar provides an overview of scientific, logistical, and regulatory considerations when using a BYOD approach to collect patient-reported outcome data in clinical trials.
Presenters: Jennifer Crager (YPrime) and Paul O’Donohoe, MS (CRF Health)
This webinar provides an overview of considerations in selecting the optimal ePRO modes, review best practices related to the deployment of ePRO systems, and discuss key items for ePRO deployment in clinical trials.
Presenters: Serge Bodart, MS (Biomedical Systems) and Elisa Holzbaur, BS, PMP (Almac)
This webinar provides a detailed description of the process for conducting paper to ePRO migration, mode-specific migrations, usability, feasibility and user acceptance testing as well as case studies of successful migrations.
Presenters: Serge Bodart, MSc (Biomedical Systems) Alisandra Johnson, BS (Bracket)
This webinar provides an overview of current ePRO data collection modes, the mode selection process, key considerations for selecting the most appropriate mode for a study and considerations for migrating an existing PRO instrument to an electronic mode.
Presenters: Cindy Howry, MS (YPrime) and Jennifer Ross, MPhilEd (Almac)
This webinar provides an overview of the ePRO Consortium, describes the various modes of PRO data capture, and discusses the trends in the collection of clinical data electronically.
Presenters: J. Jason Lundy, PhD (C-Path) and Valdo Arnera, MD (PHT Corp)