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

Author:

Zbrozek Arthur,Hebert Joy,Gogates Gregory,Thorell Rod,Dell Christopher,Molsen Elizabeth,Craig Gretchen,Grice Kenneth,Kern Scottie,Hines Sheldon

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference20 articles.

1. Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force Report. Value Health 2009;12:419-29. Available from: http://www.ispor.org/workpaper/patient_reported_outcomes/Coons.pdf. [Accessed March 26, 2013].

2. US Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. December 2009. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. [Accessed February 19, 2011].

3. European Medicines Agency. Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. 2005. Available from: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf. [Accessed February 22, 2011].

4. Paty J, Stokes T. Electronic diaries, part 1: what is a subject diary, and how do regulations apply. Appl Clin Trials 2002. Available from: http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=83521. [Accessed March 23, 2011].

5. Collecting reliable and valid real-time patient experience data;Hufford;Drug Inf J,2001

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