Teamwork in [REDCap 101 and 201] among the presenter and moderator was outstanding. Professional and friendly at the same time!
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 ‘Protocol Design and Development Stage’ and then ‘Data Systems Triage’. YNHH users without a Yale NET ID can email clinicalresearchresources@yale.edu. 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.
REDCap Instances
REDCap (Research Electronic Data Capture) is a secure web application for building and managing online surveys and databases. REDCap allows you to collect, store, organize, report, clean, and export data for analysis. While REDCap can be used to collect all types of data, it is primarily used to support research and can be used on studies involving HIPAA, 21 CFR Part 11, and GDPR regulations. There are several Yale-managed REDCap systems available to meet various regulatory requirements and needs.
How to Access
There are four REDCap systems managed by the Yale Research Informatics Office- two are housed at Yale New Haven Health System and two are housed at Yale University. To access these systems, complete the Yale Center for Clinical Investigation (YCCI) Data System Triage request here: Yale Research Project Request Form. This form is required for anyone interested in opening a new REDCap project. You will be asked for contact and protocol information. REDCap is available to faculty, staff, and students at Yale University and Yale New Haven Health System. The Data System Triage team will evaluate your request and refer you to a REDCap system based on your eligibility and project requirements.
Rates
Basic access to REDCap is available at no cost.
What is included?
This is a self-service application with video training, written tutorials, and instructor-led classes to help you learn how to use REDCap.
What is not included?
If you require professional services such as REDCap project design or builds, data management, other analytical services, software development or integration, you will need to pay for these services. You can include this request on the Yale Research Project Request Form.
Contact Information
Yale Research Informatics Office
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Existing Users and Studies: Yale -YNHHS Joint Systems
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Existing Users and Studies: Yale University
Unsure of which REDCap system your project is in? For existing REDCap projects:
If you see "REDCap at Yale” or the following base URL web addresses, your project is hosted on the ‘Yale University’ systems:
| System name | Website url |
|---|---|
| REDCap I | https://redcap.med.yale.edu |
| REDCap II | https://redcap.research.yale.edu/ |
If you see “YNHH”, “YCCI” or the following base URL web addresses, your project is hosted on the ‘Yale-YNHHS’ joint systems:
| System name | Website url |
|---|---|
| Regular/Standard REDCap | https://redcapynh.ynhh.org/ |
| 21 CRF Part 11 Validated REDCap | https://redcapynh-p11.ynhh.org |
REDCap Training
The fall training schedule for 2024 will focus on sessions for our beginner and intermediate users. We encourage you to join us and build your knowledge and skills. We also hope our intermediate to advanced users will join and share their experiences as part of our REDCap community. All Yale- and YNHHS- 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.
“[New Features] Opened new possibilities that I was immediately able to apply to the project.”
Advarra eSource + EDC
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.
Access
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
Advarra eSource + EDC Access Request Form
Please note that Yale credentials (netID and password) are required prior to requesting access.
eSource + EDC Production
Advarra Training
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.
Advarra Support
Any questions please contact edc.support@yale.edu