PraediTrial

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:	PraediTrial is clinical trial feasibility, subject recruitment, and management system. This technology can utilize data from multiple systems, including Veterans Health Information Systems and Technology Architecture (VistA)/Computerized Patient Record System (CPRS) to assist in conducting clinical trials.
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 v24.7
Decision Date:	07/16/2024 at 18:26:17 UTC
Introduced By:	TRM Request
Vendor Name:	BitScopic

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
1.2.4	06/29/2020
1.2.5

Current Decision Matrix (07/08/2024)

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

CY2024

CY2025

CY2026

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

1.2.4

Unapproved

1.2.5

Approved w/Constraints
[6, 8, 10, 11]

Approved w/Constraints
[8, 10, 11, 12, 13, 14, 15]

Decision Constraints


[1]	This technology must use the latest TRM-approved version of Java Development Kit (JDK) - Oracle. Users must ensure that Oracle database is implemented within VA-approved baselines.

[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]	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).

[5]	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.

[6]	Users must Divest the use of Apache Tomcat with this technology. This technology must use the latest TRM-approved version of Java Development Kit (JDK) - Oracle. Users must ensure that Oracle Database is implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’)

[7]	In cases where the technology is used for external connections, a full Enterprise Security Change Control Board (ESCCB) review is required in accordance VA Directive 6004 , VA Directive 6517, and VA Directive 6513. The local ISO can advise on the ESCCB review process.

[8]	New installations or major expansions of this technology that transmit data over the VA Wide Area Network (WAN) must complete a WAN impact review (yourIT Service Portal:[SNOW Service Requests]) prior to implementation to ensure proper compliance to VA network design and usage requirements.

[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 ISSO (Information System Security Officer) to ensure compliance with VA Handbook 6500.

[10]	In cases where the technology is used for external connections, a full Enterprise Security Change Control Board (ESCCB) review is required in accordance VA Directive 6004 , VA Directive 6517, and VA Directive 6513. The local ISSO (Information System Security Officer) can advise on the ESCCB review process.

[11]	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.

[12]	Users must ensure that PostgreSQL is implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must not use Open Java Development Kit (OpenJDK) with this technology as it is unapproved for use on the TRM. This technology must use the latest TRM-approved version of Java Development Kit (JDK) - Oracle.

[13]	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.

[14]	This product can be configured with a PostgreSQL Database, which currently has TRM constraints limiting its use to Red Hat Enterprise Linux (RHEL) only due to its many known security issues on other platforms. If PostgreSQL is selected for use with this product, these factors must be considered especially when an instance of this product will be considered a Moderate or High-Risk system. See PostgreSQL Database TRM entry for more details.

[15]	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 1.2.5 is the most current version.

References

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

Technology Components

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
No components have been identified for this entry.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Health Care Administrative	Quality Systems

Operating Systems Supported by the Technology

Red Hat Enterprise Linux (RHEL) - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

Apache Tomcat
JDK - Oracle Java Standard Edition (SE) Development Kit
Open Java Development Kit (OpenJDK) - (required for some configurations)
PostgreSQL

Comparable Technologies:

No comparable entries have been identified.

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This technology may improve productivity for specific staff whose responsibilities include conducting clinical trials.
At the time of writing, no National Institute of Standards and Technology (NIST) vulnerabilities had been reported and no VA Cyber Security Operations Center (CSOC) bulletins had been issued for the latest versions of this technology.

Adoption Risks

There is limited publicly available technical documentation for this technology.
This technology relies on Java Development Kit (JDK) - Oracle, which has a rapid release and update schedule.
The potential exists to store Personally Identifiable Information (PII), Protected Health Information (PHI) and/or VA Sensitive data and proper security standards must be followed in these cases.
The technology requires the purchase of licenses from vendor, which could potentially lead to vendor lock-in.
This technology may utilize external data connections.
This technology may transmit data over the VA Wide Area Network (WAN).
There is no indication based on either the vendor documentation or the Cryptographic Module Validation Program (CMVP) that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
This technology can potentially use Open Java Development Kit (OpenJDK), an unapproved technology.
This product can be configured with a PostgreSQL Database, which currently has TRM constraints limiting its use to Red Hat Enterprise Linux (RHEL) only due to its many known security issues on other platforms.
This technology can integrate with and alter database technologies.

Architectural Benefits

This technology is compatible with multiple other Technical Reference Model (TRM) technologies and standards used by the organization.
This technology is able to integrate with VistA, the Electronic Health Records (EHR) system utilized by the VA.
This technology is compatible with virtual machines, therefore consistent with the enterprise Server Virtualize First Policy (VAIQ 7266972 08-27-2012). (Add Virtualization and Consolidation of Servers (Server Virtualize First) to Supported Standards)

Architectural Risks

This technology is not portable as it runs only on Linux operating systems.
This technology does not use a VA-preferred database to store data.

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General Information

Vendor Release Information

Current Decision Matrix (07/08/2024)

Decision Constraints

References

Technology Components

VA Categories View the VA Categorization Framework

Operating Systems Supported by the Technology

Technologies/Standards Relationships

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Comparable Technologies:

Companion Technologies/Supported Standards:

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Adoption Benefits

Adoption Risks

Architectural Benefits

Architectural Risks

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VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (07/08/2024)

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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