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VA Technical Reference Model v 24.7

Electronic Data Capture (EDC)

General Information

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.

Website:	Go to site
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. Please note that there is no specific product page for this technology and thus the vendor webpage is used in its place. 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: https://dvagov.sharepoint.com/sites/OITECSO
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 Section508@va.gov.
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v24.6
Decision Date:	06/26/2024 at 16:14:49 UTC
Aliases:	DataLabs; DataLabs Electronic Data Capture (EDC); Calyx EDC; Calyx DataLabs EDC
Introduced By:	TRM Request
Vendor Name:	Calyx

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Technology, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
5.0	04/01/2011
5.3	12/19/2014
5.4	10/08/2015
5.6.x	05/31/2017
5.7.x
5.8.x
5.9.x
5.10.x

Current Decision Matrix (06/21/2024)

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.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

<Past

CY2023

CY2024

CY2025

Future>

Release

5.0

Unapproved

5.3

Unapproved

5.4

Unapproved

5.6.x

Unapproved

5.7.x

Approved w/Constraints
[4, 13, 14, 15, 16]

Approved w/Constraints
[4, 13, 14, 16, 17]

Approved w/Constraints
[4, 14, 17, 18, 19]

Divest
[4, 17, 18, 19, 20, 21]

Unapproved

5.8.x

Unapproved

Divest
[4, 17, 18, 19, 20, 21]

Unapproved

5.9.x

Unapproved

Divest
[4, 17, 18, 19, 20, 21]

Unapproved

5.10.x

Unapproved

Approved w/Constraints
[4, 17, 18, 19, 20, 21]

Decision Constraints


[1]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[2]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[3]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[4]	Technology must remain patched and operated in accordance with Federal and Department security policies and guidelines in order to mitigate known and future security vulnerabilities.

[5]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[6]	Due to potential information security risks, cloud based technologies may not be used without the approval of the Enterprise Cloud Solution Office (ECSO). This body is in part responsible for ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[7]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request with the Project Special Forces (SPF) team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[8]	Users must ensure that Microsoft Internet Explorer (IE) , Microsoft Internet Information Services (IIS) , Microsoft .NET Framework, and Microsoft Structured Query Language (SQL) Server are implemented with VA-approved baselines.

[9]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[10]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[11]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request with the Project Special Forces (SPF) team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[12]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request with the Project Special Forces (PSF) team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[13]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request with the VA OIT Product Engineering team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[14]	Users must ensure that Microsoft Internet Information Services (IIS) and Microsoft Structured Query Language (SQL) Server are implemented with VA-approved baselines.

[15]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with VA Handbook 6500.

[16]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information System Security Officer (ISSO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[17]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with both VA Handbook 6500 and VA Directive 6500.

[18]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 or its successor to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 or 140-3 compliant full disk encryption (FOE) must be implemented on the storage device where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information System Security Officer (ISSO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP). By September 22, 2026, all FIPS 140-2 certificate validations will be placed on the Historical List, please refer to FIPS Transition Effort for further guidance and timeline of changes.

[19]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request, visit the Product Marketplace. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[20]	Users must ensure that Microsoft Internet Information Services (IIS) and Microsoft Structured Query Language (SQL) Server are implemented with VA-approved baselines. If free trialware is utilized, the software must be purchased or removed at the end of the trial period.

[21]	The Federal Information Processing standards (FIPS) 140-2 certification status of this technology was not able to be verified. This technology will require a 3rd party FIPS 140-2 or 140-3 certified solution for any data containing PHI/PII or VA sensitive information, where applicable. More information regarding the Cryptographic Module Validation Program (CMVP) can be found on the NIST website.

Note:

At the time of writing, version 5.10.1.1 is the most current version.

The following reference(s) are associated with this entry:
Type	Name	Source	Description
There are no references identified for this entry.

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Name	Description
DataLabs Designer	The DataLabs Designer application is designed to enable users, without programming background or expertise, to build EDC studies through an interface. Users can create new studies by choosing components from their centralized repository of study design objects, including options to reuse pre-validated forms and components from previous or existing studies.


Health Care Administrative	Health Delivery Support

- The information contained on this page is accurate as of the Decision Date (06/26/2024 at 16:14:49 UTC).

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VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (06/21/2024)

Decision Constraints

References

Technology Components

VA Categories View the VA Categorization Framework

Operating Systems Supported by the Technology

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

Adoption Risks

Architectural Benefits

Architectural Risks

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