Electronic Data Capture

There are two Electronic Data Capture systems managed by the Yale Research Informatics Office – REDCap and Advarra eSource + EDC. Both systems are secure web applications for building and managing case report forms and surveys. The two systems allow you to collect, store, organize, report, clean, and export data for analysis. The Yale EDC systems can meet various regulatory requirements and needs, including HIPAA, 21 CFR Part 11, and GDPR.

To start a new project on these systems, complete the Yale Center for Clinical Investigation (YCCI) Data System Triage request here: YCCI Service Request Submission. Select 'Data Systems Triage' from the request form options. YNHHS personnel without a Yale NET ID can email clinicalresearchresources@yale.edu, indicating that they are requesting 'Data Systems Triage' and including the study protocol or a description of their project.

This form is required for anyone interested in opening a new project in either of the Yale Electronic Data Capture systems. The Data System Triage team will evaluate your request and refer you to a system based on your regulatory and project requirements.

Please refer to the Part 11 Guidance created by the Yale HRPP, which provides an overview of Part 11 regulations. This document outlines the applicability of Part 11 to FDA-regulated human subjects research and details the requirements for Part 11 compliant technology. It also includes relevant regulations, references, and citations, along with decision trees for eConsent and data system considerations.