Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes скачать в хорошем качестве

Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

This article presents key best practices that are aligned to the latest health authority guidance. From 2018 to 2022, 45 representatives of C-Path’s Patient-Reported Outcome Consortium, eCOA Consortium, and the eClinical Forum collaborated to develop guidelines on changes to eCOA data. The resulting core principles can become the foundation upon which sponsors, investigators, and eCOA providers can evaluate and manage data change requests. SUBSCRIBE to C-Path's YouTube Channel Now ►►    / criticalpathinstitute   FOLLOW C-Path: ►LinkedIn:   / c-path   ►Facebook:   / cpathinstitute   ►Twitter: https://twitter.com/CPathInstitute?re About Critical Path Institute C-Path is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org. #CPath #drugdiscovery #researchgrants #globalhealth #drugdevelopment #datasharing #researchfunding #raredisease #academicresearch #regulatoryscience #globalhealth #consortia #collaboration #FDA #EMA #T1D #Parkinsons #Alzheimers #PKD #Duchenne #ALS #biomarkers