CRIO President and COO authors new JSCDM Article
Congratulations to CRIO President and COO Jonathan Andrus on the publication of “Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes” in the Journal of the Society of Clinical Data Management.
This long awaited publication, a joint effort by industry thought leaders in the area of clinical data, summarizes the guidelines for eCOA data changes developed by the Critical Path Institute (C-Path)’s Patient-Reported Outcome (PRO) Consortium, eCOA Consortium (previously ePRO Consortium), and ECLINICAL FORUM LIMITED.
According to the authors “This work coincided with a shift in clinical trial industry practices and emergence of regulations and quality functions that require that investigative sites, not sponsors, be responsible for the maintenance of accurate source records.”
At CRIO, we support sites being the ultimate stop gap for data quality. Thank you to Society for Clinical Data Management (SCDM) for their support of this important publication.
Click here to read the full article.