Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints

The objective of this paper is to describe study site-, subject-, and technology-related factors that may lead to deviations from the planned electronic collection of PRO data (eg, defaulting to paper-based data collection) and to provide recommendations aimed at preventing potential problems or quickly resolving problems once they occur.

Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Fleming, S., Barsdorf, A. I., Howry, C., O'Gorman, H., Coons, S. J., on behalf of the Patient-Reported Outcome (PRO) Consortium and the ePRO Consortium at the Critical Path Institute Tags: Special Section on Clinical Outcome Assessments Source Type: research