News & Events
May 16, 2019
Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials (May 16, 2019)This webinar provides an overview of the issues related to the use of paper backups in studies for which PRO data is collected electronically. Viable strategies to eliminate the necessity of a paper-backup system are provided. Presenters: Cindy Howry, MS (.assisTek) and Paul O’Donohoe, MSc (Medidata Solutions) PDF version...
May 10, 2018
Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium (May 10, 2018)This webinar provides a recommended framework for training end users, including site staff and study participants, on the use of ePRO technology in clinical trials. The goal of the webinar is to promote consistent and sufficient training prior to initiating data collection. Presenters: Jenny J. Ly, PhD (ERT) and Serge Bodart, MSc (Bracket) PDF version...
June 6, 2017
Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO ConsortiumThis 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,......
February 28, 2017
Considerations for Requiring Subjects to Respond to PRO Instruments Collected ElectronicallyThis 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. Presenters: Paul O’Donohoe, MS (CRF Health) and Sonya Eremenco, MA (C-Path) PDF version...
January 31, 2017
Bring Your Own Device (BYOD)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) PDF version...