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ClinSpark can be configured to work with VCT such that over-volunteering checks to occur in an automated and efficient capacity, helping to improve overall clinical trial data quality and processes. These processes happen securely, and a clear audit trail is maintained within the application where applicable.
Applicability
This document applies to ClinSpark versions 1.5.0 and greaterall current supported versions of ClinSpark.
Requirements
The interface requires the following:
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User Requirements Specification (URS) is not included. Foundry Health IQVIA has reviewed the general requirements of the user community and used these to determine Functional and Non-Functional Requirements for this ClinSpark component.
ClinSpark Infrastructure specification (documented separately)
ClinSpark Architecture specification (documented separately)
ClinSpark Configuration Specification (documented separately)
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Testing has occurred to confirm data integrity upon transfer from VCT to ClinSpark.
Demonstration
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The following screencast demonstrates the interface on an earlier Clinspark release. While some configuration steps have changed since the screencast was recorded, the general workflow is still applicable to current release builds. |
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System Specifications
Functional Requirements
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The interface is intended to be installed and configured by qualified users. In most pharmaceutical and associated life-science settings, this is typically governed through an Information Systems/Technology administrator or support team.
Once installed and configured, ClinSpark application users can leverage the interface through the regular use of the ClinSpark application.
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The interface is reliant on the use of the Verified Clinical Trials web application. It is to be expected that Verified Clinical Trials continue to develop and support their web application, and additional capabilities brought to market. Foundry Health IQVIA will maintain the interface through ongoing collaboration and support with Verified Clinical Trials, where applicable.
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ClinSpark Configuration
General Settings
Foundry Health staff (superadmin users) IQVIA ‘superadmin’ users must enable the VCT interface via system-wide configuration setting. The interface is typically enabled during customer onboarding phases, but otherwise, must be enabled at request via the Service Desk.
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For regular use, we recommend that the production endpoint be setup in the ClinSpark PROD MAIN instance, and the testing endpoint endpoints setup in the PROD TEST instance. Lower environments environment such as VAL , UAT, or Sandbox should use the Testing applicable testing endpoints.
Per GDPR specifications, VCT has established separate URLs for EU and non-EU customers.
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Dev (US): https://dev.vctrials.com/ (note - only used by Foundry Health dev team)
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Testing (US): https://qa.vctrials.com/site/index.aspx
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Testing (EU): https://qa-eu.vctrials.com/site/index.aspx
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Production (US): https://www.vctrials.com/site/index.aspx
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Customers should reach out to VCT to clarify what endpoint URLs are expected for their use of the system. IQVIA does not maintain these endpoints. |
Partner ID
The VCT interface partner ID is required per HTTP POST specification.
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When a study is setup with more than one site configuration, it’s expected that all study sites have the same configured VCT endpoint URL in order for the integration to work successfully. This is true even under scenarios where only some study site may be using the VCT interface.
If customers encounter this multi-site study setup scenario, they should reach out to Foundry Health IQVIA support if there are any questions on how to best use the interface for that study.
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As part of site configuration, Foundry Health ‘superadmin’ users can define a transform script value. Transform script configurations enables a way to meet site specific requirements for the VCT interface that is otherwise not possible based on the default interface logic.
Certain usage of the transform script may require Foundry Health IQVIA and VCT to collaborate on parameters passed. If necessary, VCT may need to update their interface to accept different values that are requested to be passed from ClinSpark.
Customers are encouraged to reach out and work with Foundry Health IQVIA and VCT together to discuss unique requirements that would be defined through use of a transform script. Most commonly, we work with sites to establish transform script logic handling these use cases:
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If customers are being forced to re-authenticate into ClinSpark each time they are returned from VCT on over-volunteering checks, then it’s possible that the Foundry Health IQVIA ClinSpark team may need to investigate a potential infrastructure update. Sometimes these forced workflows are related to a change made in Google Chrome version 80 related to and SameSite flag cookie enforcement. To address this, please reach out via service desk ticket.