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PRO TASK FORCE: GOOD RESEARCH PRACTICES FOR ePRO SYSTEMS VALIDATION

Validation of Electronic Systems to Collect Patient-Reported Outcome (PRO) Data – Recommendations for Clinical Trial Teams:
Report of the ISPOR ePRO Systems Validation Good Research Practices Task Force

The citation for this report is:
Zbrozek A, Hebert J, Gogates G, et al. Validation of electronic systems to collect patient-reported outcome (PRO) data - Recommendations for clinical trial teams: Report of the ISPOR ePRO systems validation good research practices task force. Value Health 2013:16:480-9.

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Excerpt of ePRO Systems Validation Task Force Report:
Essential Components of the Validation Process

Editorials on Task Force Report:
Digitization of Patient-Reported Outcomes
ePRO Systems Validation: Clearly Defining the Roles of Clinical Trial Teams and ePRO System Providers

Leadership Group:
Arthur S. Zbrozek, RPh, MSc, MBA, Senior Director and Group Leader, Commercial Development, Global Health Economics, CSL Behring, Biotherapies for Life, King of Prussia, PA, USA
Gretchen Craig, Director of Quality Assurance, ERT, Inc., Pittsburgh, PA, USA
Christopher Dell, Director, Health Outcomes Solutions Implementation, ERT, Philadelphia, PA, USA
Gregory Gogates, BS, Vice President, Quality Management & Regulatory Affairs, CRF Health, Plymouth Meeting, PA, USA
Kenneth Grice, Associate Director, ePRO Operations, Global Electronic Data Capture, Bayer HealthCare Pharmaceuticals Inc., Montville, NJ, USA
Joy Hebert, BA, Director, Project Quality and Performance Improvement, PHT Corp, Boston, MA, USA
Sheldon Hines, Project Manager, eCOA and Innovation, ICON Late Phase & Outcomes Research, Durham, NC, USA
Scottie Kern, BSc (Hons), Director, Sacaja Consulting Ltd., Wiltshire, England, UK
Rod Thorell, Director, Quality & Compliance, PHT Corp, Charlestown, MA, USA


ISPOR Good Practices For Outcomes Research Index