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VA Technical Reference Model v 24.4

Electronic Data Capture (EDC)
Electronic Data Capture (EDC) Technology

General InformationGeneral Information help

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

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Description: The Electronic Data Capture (EDC) solution provides an electronic clinical data management platform that utilizes Paper Data Entry (PDE) and EDC. This application supports clinical trials and enables studies to include worksites using paper Case Report Forms (CRFs) and other existing paper processes. This application also allows for the method of data capture to switch at any point during the study.

Contract research organization (CRO) Parexel announced in 2021 that the company completed a strategic separation of its Informatics and Medical Imaging business, which has been established as a new company named Calyx.

This technology is a web-based application hosted on VA premises that stores study metadata (study design properties), operational data (site and query information), and clinical data (patient data) in a Microsoft Structured Query Language (SQL) Server database residing on VA servers. The system uses native SQL secure mechanism to store data. DataLabs applies encryption to transactions between site client machines and the production servers to ensure that privacy and security of data transactions is maintained. Additionally, this technology is available as a cloud solution.

The TRM decisions in this entry only apply to technologies and versions owned, operated, managed, patched, and version-controlled by VA. This includes technologies deployed as software installations on VMs within VA-controlled cloud environments (e.g. VA Enterprise Cloud (VAEC)). Cloud services provided by the VAEC, which are listed in the VAEC Service Catalog, and those controlled and managed by an external Cloud Service Provider (i.e. SaaS) are not in the purview of the TRM. For more information on the use of cloud services and cloud-based products within VA, including VA private clouds, please see the Enterprise Cloud Solutions Office (ECSO) Portal at:
Technology/Standard Usage Requirements: Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information: This technology has not been assessed by the Section 508 Office. The Implementer of this technology has the responsibility to ensure the version deployed is 508-compliant. Section 508 compliance may be reviewed by the Section 508 Office and appropriate remedial action required if necessary. For additional information or assistance regarding Section 508, please contact the Section 508 Office at
Decision: View Decisions

Decision Source: TRM Mgmt Group
Decision Process: One-VA TRM v22.12
Decision Date: 12/05/2022 at 17:52:45 UTC
Aliases: DataLabs; DataLabs Electronic Data Capture (EDC); Calyx EDC
Introduced By: TRM Request
Vendor Name: Calyx
- The information contained on this page is accurate as of the Decision Date (12/05/2022 at 17:52:45 UTC).