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Electronic Clinical Outcome Assessments (eCOA) - An Introductory Guide

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Electronic Clinical Outcome Assessments An Introductory Guide Every clinical trial strives to capture high quality subject data that can be analyzed and then used to help bring therapies to market. However, one of the most common findings in investigator site inspections is a lack of reliable, accurate and adequate source documentation. This also is the most common issue that is identified during audits. Why does this occur? Often it is because the trial is relying on paper for data collection and documentation. Paper-based clinical trials are at a considerable disadvantage for a number of reasons and on a number of fronts. Writing answers that are illegible. Only partially completing answers or part of the questionnaire. Incorrectly filling in sections as checking two answer boxes instead of one, or marking scales incorrectly. Completing questionnaires at a time other than the one specified by the protocol - such as in the parking lot before a site visit.

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