Definition and Basics

Evaluating Risk in the Era of Decentralized Clinical Trials - By Allison ... October 25, 2023 Applied Clinical Trials SCOPE Europe 2023 Roundtable: eCOA- and ePRO ... Studies of other ePRO systems have typically focused on ... Lack of timely accrual information in oncology clinical trials: a cross-sectional analysis. May 15, 2023 ... The US Food and Drug Administration has made it clear that electronic capture of clinical trial source data is preferred over paper-based data ... Informed consent is a critical-to-quality (CTQ) factor for patient safety in clinical trials. ... informational document for study participants. Longer ... ... Patient surveys, quality management, quality assurance, clinical trials software / Heinz Neuwirth ... tools' ePRO solution, Patient-Reported Outcomes for ... Global Medical Publications and Information Coordinator · Experience: Ipsen · Education: Queen Mary University of London · Location: Dunstable · 259 ... Dec 11, 2017 ... In today's environment we are seeing many electronic patient reported outcome (ePRO) ... According to FDA guidance “Open-label clinical trials, ... Aug 27, 2013 ... Continuous Safety Monitoring for Randomized Controlled Clinical Trials with Blinded Treatment Information ... ePRO, web-based ... May 17, 2023 ... Asking which decentralized elements they use in their trials so far, 43% of the participants from trial sponsors and CROs said “ePRO“, while 37% ... Oct 26, 2017 ... An additional section has been added in order to capture information related to the echocardiographic sub-study. 6.3 Recording of adverse events.