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: Yale Research Project Request Form. 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.

The fall training schedule focuses on sessions for our beginner and intermediate users. We encourage you to join us and build your knowledge and skills. The spring training schedule focuses on sessions for intermediate to advanced users. All REDCap users are welcome!

Please note: These sessions are focused on standard REDCap systems and do not cover the 21 CFR Part 11 compliance requirements.

View Current Training Offerings

View Training History Offerings

The REDCap User Group is a way for REDCap developers across the Yale / YNHH system to connect, learn about REDCap's most advanced features, and keep up with updates. We host meetings with guest presentations and discussions, and maintain a Teams channel with resources for RC developers and Q&A support. If your role involves building or managing RC databases, we strongly encourage you to sign up!

Join the REDCap User Group – Sign Up Here!

Advarra eSource + EDC is a 21 CFR Part 11 compliant system designed to improve and streamline electronic data collection, management, monitoring, and review processes.

The system enhances the integrity and quality of data for studies throughout the organization, particularly investigator-initiated and FDA-regulated studies, by offering robust traceability and auditing features. It records user actions, dates, and timestamps for all data creation and modifications within the system. Additionally, it offers electronic signature capabilities for Principal Investigator approval of Case Report Forms (CRFs).

eSource + EDC integration with OnCore clinical trial management system (CTMS) minimizes duplicate data entry, while maintaining consistent information across systems. This integration streamlines data management for Organizations, Protocols, and Subjects. The system is also integrated with Epic to retrieve lab results automatically for research.

Before obtaining access, each prospective user must:

• Submit an access request form
  
• Have a valid Yale NetID
  
• Complete the training assigned to them in Advarra University after submitting the above listed access request form
  

Training for Advarra eSource + EDC is completed in Advarra University, Advarra’s training website. Training information will be sent to each user following the submission of their access request form.

Any questions, please contact edc.support@yale.edu.