CDER SBIA Webinar - Federal Register (FR) Notice: Source Data Capture from Electronic Health Records: Using Standardized Clinical Research Data - July 7, 2015
On Tuesday, July 7, 2015, the Offices of Strategic Programs (OSP) and Translational Sciences (OTS) in the Center for Drug Evaluation and Research (CDER) will present a webinar on the Federal Register (FR) Notice: Source Data Capture from Electronic Health Records: Using Standardized Clinical Research Data.
CDER is interested in supporting demonstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach, using established data and implementation standards in a regulated clinical research environment. A demonstration project should ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information within a single system and workflow. Stakeholders may include regulated industry, EHR and EDC vendors, academic medical centers, and other interested parties.
Pre –registration is required for this webinar.
Upon registration you will receive the webinar link.
Documents: Federal Register Notice (FRN)
Federal Register Publication Date: 06/26/2015
Comments Date: 08/10/2015
Docket Number: FDA-2015-N-1887