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VA Technical Reference Model v 24.11

Integrated Research Information System (iRIS)

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:	Integrated Research Information System (iRIS) is software composed of a set of scalable research compliance applications which communicate through a common database portal. Modules can be purchased/leased separately or integrated into the system of research modules. This product has the capability to assist in complying with federal regulations in research. This technology stores data in a Microsoft Structured Query Language (SQL) Server database and an Oracle Database.
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 v22.10
Decision Date:	10/18/2022 at 16:18:07 UTC
Introduced By:	TRM Request
Vendor Name:	iMedRIS

Vendor Release Information

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

You must be logged into the RSAA website prior to clicking the Attestation URLs or the URLs won't open.

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
8.02	02/17/2009
9.01
9.02
9.03
10.01
10.02
10.03	08/12/2015
10.03.x	08/18/2016
11.x	07/31/2018
12.x	08/01/2020
13.x	08/01/2021

Current Decision Matrix (10/09/2022)

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 VAIT 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.

Legend:

White	Authorized: The technology/standard has been authorized for use.
Yellow	Authorized 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	Authorized w/ Constraints (POA&M): 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	Authorized w/ Constraints (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 unauthorized may be found on the Decision tab for the specific entry.
Black	Unauthorized: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Authorized w/ Constraints (PLANNING/EVALUATION): 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 authorized 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 authorized 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.

Any major.minor version that is not listed in the VA Decision Matrix is considered Authorized w/ Constraints (POA&M).

<Past

CY2020

CY2021

CY2022

Future>

Release

10.02

Unapproved

10.03

DIVEST
[6, 7, 8, 9]

Unapproved

10.03.x

DIVEST
[6, 7, 8, 9]

Unapproved

11.x

Approved w/Constraints
[6, 7, 8, 9]

Approved w/Constraints
[8, 9, 10, 11]

DIVEST
[8, 10, 11, 12]

12.x

Unapproved

Approved w/Constraints
[8, 10, 11, 12]

13.x

Unapproved

Approved w/Constraints
[8, 10, 11, 12]

Decision Constraints


[1]	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.

[2]	Projects using this technology must meet Veterans Affairs (VA) Directive 6500 and implement Federal Information Processing Standards (FIPS 199) for all laptop devices and National Institute of Standards and Technology Special Publication 800-53 for all desktop devices when VA sensitive information is involved, or additional mitigating controls must be documented in an authorized System Security Plan (SSP) to prevent potential disclosure of PII/PHI data. Additionally, projects which interface with external VA partners must have a Memorandum of Understanding and Interconnection Security Agreements (MOU/ISA), which detail the security requirements for users and systems that share information and resources outside of the VA production network.

[3]	As of April 23, 2015, per the Deputy CIO of Architecture, Strategy and Design (ASD), all technologies in use by the VA require an assessment by the VA Section 508 office. Section 508 of the Rehabilitation Act Amendments of 1998 is a federal law that sets the guidelines for technology accessibility. A VA Section 508 assessment of this technology has not been completed at the time of publication. Therefore, as of April 23, 2015 only users of this technology who have deployed the technology to the production environment, or have project design and implementation plans authorized, may continue to operate this technology. In the case of a project that has implemented, or been authorized for a specific site or number of users, and that project needs to expand operations to other sites or to an increased user base, it may do so as long as the project stays on the existing version of the technology that was authorized or implemented as of April 22, 2015. Use of this technology in all other cases is prohibited.

[4]	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.

[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]	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).

[7]	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.

[8]	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.

[9]	Users must ensure that Microsoft Internet Information Services (IIS), Microsoft Structured Query Language (SQL) Server and Oracle Database are implemented with VA-authorized baselines.

[10]	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.

[11]	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).

[12]	Users must ensure that Microsoft Internet Information Services (IIS), Apache Tomcat, Microsoft Structured Query Language (SQL) Server, and Oracle Database are implemented with VA-authorized baselines. Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM.

Note:

At the time of writing, version 13.01 is the most current version, released 08/01/2021.

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
Animal Resource Center (ARC) Assistant	Animal Resource Center (ARC) Assistant works in conjunction with Institutional Animal Care and Use Committee (IACUC) to manage and maintain its animal ordering, processing, breeding, per diem and cage censuses. ARC Assistant assists institutions in complying with mandated regulations.
Conflict of Interest (COI) Assistant	Conflict of Interest (COI) Assistant is used to manage an institutions annual disclosure reviews and submission specific disclosures. Research communities report their annual disclosures to their institutions COI officer through an online submission process. Users have the ability to create a paperless review and sign-off process, generate letter correspondence and see the status of the review.
Effort Reporting Assistant	Effort Reporting Assistant allows each user to capture the actual time it took to complete not only their patient related tasks, but also other study related activities for a given period of time. Reviewers can reject time cards, send them back for correction and filter reports by date, staff member and project.
Feasibility Assistant	Feasibility Assistant electronically submits study proposals to the Feasibility Board for approval. The module is used to report on all resources needed in the clinical trial study, such as budget, overhead, subjects, drugs and devices and timelines. Feasibility Assistant also allows users to route documents internally and view them Online before, during and after submission.
Flex Board Assistant	Flex Board Assistant is an up-to-date and configurable review board administration module. This utility assists users in designing custom review board software to meet the specific needs of an institution. Users can create and submit applications and forms electronically, and can accomplish routing and reviewing processes efficiently via email alerts and internal system notifications.
Institutional Animal Care and Use Committee (IACUC) Assistant	IACUC Assistant enables researchers to submit their projects electronically for review. The module is used to complete, attach, accept and forward project forms to the IACUC for evaluation. Configurable applications specific to institutional policies ensure that projects are received with comprehensive information.
Institutional Review Board (IRB) Assistant	IRB Assistant is the clinical researcher`s solution to charting work in hard copy files. This module is used to submit applications and other related forms to specific review boards electronically.
Multi-Site Assistant	Multi-Site Assistant allows collaboration, assists in relieving Institutional Review Board (IRB) burdens, expedites the process of conducting multi-site trials, reduces work duplication, and helps cut expenses. This module may be useful in creating a consistent review process for any size research network.
Pre-Award Assistant	Pre-Award Assistant allows institutions to internally route funding applications and supporting documentation to the Grant and Contracts office for review and processing. The module tracks funding status, amount and pre-award accounting. The continuous connection to Grants.gov creates a function in eProposal Assistant that sends out notifications of funding prospects as they become available.
Radiation Safety Assistant	Radiation Safety Assistant allows institutions to submit study criteria to the Radiation Safety Committee (RSC) and establish guidelines for researchers who report to the Nuclear Regulatory Commission. Radiation Safety Assistant is completely paperless and uses logic to guide users through each section of forms, based on their responses.
Scientific Review Board (SRB) Assistant	The Scientific Review Board Assistant automates the review process by integrating site activities directly with the review board(s). Review Board(s) personnel are supplied with submission packets, subject enrollments and study compliance issues as they are entered. Pre-meeting study information is also available electronically to Review Board Members.
Study Management Assistant	Study Assistant is a featured package for managing various aspects of a clinical study. Some of the main areas include: patient requirements recruiting, screening, and enrollment), doctor and institution requirements (staff qualifications, previous experience, and potential problems), case report forms, and modifiable data collection points. Study Assistant allows for the configuration of applications to automatically branch to the next logical question in a form, based on the user`s response to specific questions.
The Institutional Biosafety Committee (IBC) Assistant	The Institutional Biosafety Committee (IBC) Assistant permits researchers in the Biosafety industry to submit applications and other related forms electronically to the IBC. By viewing all protocol documents Online, reviewers can record comments, make recommendations, provide stipulations and prepare outcome letters electronically with IBC Assistant.


Collaboration and Electronic Workplace Productivity Software	Miscellaneous Productivity Tools and Utilities

General Analysis

Adoption Benefits

This is a mature technology.
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.
This technology may improve productivity for specific staff whose responsibilities include research and compliance audits.
This technology provides technical support via phone and ticket submittal via online customer portal.

Adoption Risks

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.
There are other authorized solutions that provide similar functionality available on the TRM. The use of several similar solutions may increase organization requirements for support and maintenance.
Due to the rapid release schedule of this technology, the VA may be unable to update to the most recent patch and may require a deployment model requiring the use of specific versions.
This technology can integrate with and alter database technologies.
This technology can potentially use Secure Sockets Layer (SSL), an unapproved protocol.

Architectural Benefits

This technology is portable as it runs on multiple TRM-authorized operating systems.
This technology can integrate with a Health Information System (HIS).
This technology can be extended through the use of optional modules for additional functionality.
This technology can use a VA-preferred database.

- The information contained on this page is accurate as of the Decision Date (10/18/2022 at 16:18:07 UTC).

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VA Technical Reference Model v 24.11

General Information

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Current Decision Matrix (10/09/2022)

Decision Constraints

References

Technology Components

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VA Technical Reference Model v 24.11

General Information

Vendor Release Information

Current Decision Matrix (10/09/2022)

Decision Constraints

References

Technology Components

VA Categories View the VA Categorization Framework

Operating Systems Supported by the Technology

Technologies/Standards Relationships

Runtime Dependencies:

Optional Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

Adoption Risks

Architectural Benefits

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VA Categories

View the VA Categorization Framework