Dacima 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:	Dacima Clinical Suite is a web-based electronic data capture (EDC) and clinical data management system (CDMS) for capturing, managing and reporting clinical research data and optimizing data collection by streamlining the clinical data collection process. This technology assists users in the creation of databases for different study designs including clinical trials, observational studies, web surveys, and patient registries. Also, this technology provides capabilities like track changes to data and history, manage all users` projects/studies from one application and enhance data quality. Data is stored in a Microsoft Structured Query Language (SQL) Server database. Additionally, the vendor offers Software as a Service (SaaS) hosted models. This technology provides both secure data hosting and storage (SaaS) or installing the technology on premises. Note: This technology was rebranded from Dacima Clinical Suite to Dacima Electronic Data Capture (EDC). This entry covers the Desktop Edition of this technology and not any mobile versions. Please note that the implementation of mobile technology applications that operate on Mobile Operating Systems must be reviewed and approved by the Mobile Technology and Endpoint Security Engineering Team: http://vaww.eie.va.gov/SysDesign/CS/MT/default.aspx 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 v24.1
Decision Date:	01/18/2024 at 02:49:59 UTC
Aliases:	Dacima Clinical Suite
Introduced By:	TRM Request
Vendor Name:	Dacima Software, Inc

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
3.3.x	09/01/2015
4.2.x
4.3.x

Current Decision Matrix (01/10/2024)

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

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CY2019

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

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Q4

Q1

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Q4

3.3.x

Approved w/Constraints
[1, 2, 3, 4]

Approved w/Constraints
[1, 2, 3, 5]

Approved w/Constraints
[1, 6, 7, 8]

Approved w/Constraints
[1, 6, 7, 9]

Approved w/Constraints
[1, 6, 7, 9, 10]

4.2.x

Unapproved

4.3.x

Unapproved

Decision Constraints


[1]	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.

[2]	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.

[3]	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).

[4]	Due to potential information security risks, cloud based versions of this product are not permitted without a waiver signed by the Deputy CIO of ASD based upon a recommendation from the Architecture and Engineering Review Board (AERB). In addition, cloud based features of this software may not be used without an Enterprise Security Change Control Board (ESCCB) approval to ensure that confidential organization and/or PII/PHI data are not compromised (ref: VA Directive 6004, VA Directive 6517 and VA Directive 6513). Use of public cloud storage requires documented Federal Risk and Authorization Management Program (FedRAMP) compliance and a Memorandum of Understanding / Interconnection Security Agreement (MOU/ISA) between the vendor and VA prior to ESCCB review.

[5]	Due to potential information security risks, cloud based technologies may not be used without an Enterprise Security Change Control Board (ESCCB) approval. 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).

[6]	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.

[7]	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).

[8]	Due to potential information security risks, cloud based technologies may not be used without the approval of the VA Enterprise Cloud Services (ECS) Group. 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).

[9]	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).

[10]	If free trialware is utilized, the software must be purchased or removed at the end of the trial period.

Note:

At this time of writing, version 4.3.6 is the most current.

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
Administrator Module	The administrator module allows the admin the create and manage users, including assigning roles and permission, creating user groups. The admin can also create centres/sites, configure password complexity requirements, password expiration requirements, 2-factor authentication, secure fields that a restricted to authorized users only, as well as activate Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization Drug Dictionary (WHODrug) coding, enable new languages and other administrative tasks.
Alert Centre	This component is for an authorized user to view alerts and notifications sent through deep links.
Data Entry module	The data entry module allows users to add subjects, collect data, and track subject status and the data entry status.
Designer module	The designer module allows users to configure the study design and build custom data entry forms, validation checks, formulas, piping, and more, through a web interface. No computer programming is required.
Drug/Device Management Module	The drug/device management module integrates with the Interactive Web Randomization System (IWRS) for drug allocation of dispensing codes (bottle, kit codes or device codes) for the patient. The module automatically selected appropriate dispensing systems based on the study arms in which the patient is randomized, allows for resupply options if the patient need to be resupplied at specific time points and parameter configuration option for resupply reasons, and linking drugs to study arms.
Emergency Unblinding Module	This component allows for unblinding of patient allocation in the Interactive Web Randomization System (IWRS) by authorized users. It is tracked in the audit trail and reports of all unblinded patients available to authorized users.
Gathering Module	The gathering module is used to manage group session with patients (in clinic database design).
Interactive Web Randomization System (IWRS)	The IWRS module integrates with the software for the configuration of the electronic data capture (EDC) to allow randomization of patients for clinical trials, and for users to then recruit and randomize patient through the data entry interface.
Manager module	The manager module and role-based access give the ability to manage users and control access to the study database.
Medical Coding Module	The medical coding module includes options for Medical Dictionary for Regulatory Activities (MedDRA) coding and World Health Organization Drug Dictionary (WHODrug) coding. The system allows users to upload the data dictionaries you receive from these organization after purchasing a license from them. Then the audit can assign roles to users to permit them to access the Dacima coding modules for MedDRA and WHODrug.
Offline Application (Apps)	The offline apps can be generated based on the web study database design.
Push Module	The push module is used to configure tablets or computer to have questionnaires (for Electronic Patient Reported Outcomes (ePRO) design studies) pushed via the web to the device so that users can have a series of tablets or computers in a clinic or other room where users can send subject to self-complete questionnaires.
Volunteer Management Module	This component is an option to manage volunteers for studies that have educational interventions that require a volunteer or instructor to provide information about the intervention. The modules allow for scheduling classes, and the instructors to volunteer for available time slots, cancel and remind them of their upcoming sessions.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Information Management Technologies Business Intelligence and Data Warehouse Platforms	Web Reporting Tools
Information Management Technologies Business Intelligence and Data Warehouse Platforms	Clinical Environment and Tools

Operating Systems Supported by the Technology

Windows Server - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

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 can track changes to data and history.
This technology offers offline options allowing users to generate a client application from the web database which can be installed on Personal Computers (PCs) for offline data entry making it ideal for data collection in regions with poor and unreliable internet connectivity.
This is a multi-lingual technology supporting English, French, Spanish, and Chinese with the ability to incorporate other languages.
This technology allows electronic signature and monitoring features.
This technology offers data validation features and options that may reduce errors and improve data quality.
This is a well-supported technology.

Adoption Risks

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 Secure Sockets Layer (SSL), an unapproved protocol.
There are other approved solutions that provide similar functionality available on the TRM. The use of several similar solutions may increase organization requirements for support and maintenance.
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 is limited public documentation available for this technology.
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.

Architectural Benefits

This technology is built on a scalable architecture. It allows managing a single clinical trial, study, or a large multi-center international study. This technology allows managing all projects/studies from one application.
This technology can use a VA-preferred database.

Architectural Risks

This technology is not portable as it runs only on Windows platforms.
This technology includes cloud-based functionality which has potential information security risks.

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