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Supports the selection and configuration of appropriate volunteer identification documentation per site.
Supports the deployment of standard forms including a ‘VCT’ button to manage the over-volunteering workflow.
Supports the one-time verification of a volunteer’s status per cohort per trial.
Supports the use of specific role action called “VCT Support” allowing use of the VCT redirect features in Over-volunteering forms
Supports automated user authentication to the VCT portal.
Supports the secure transmittal of applicable study, protocol and volunteer details from ClinSpark to VCT.
Supports automated verification in VCT, and redirection back to ClinSpark.
Supports the update of the Over Volunteering form with the status provided by VCT, and the retrieval and retention of a PDF certificate generated by VCT.
Supports the review and comment on the over-volunteering status by site staff.
Supports a full audit trail.
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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
Superadmin 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 or Sandbox should use the Testing applicable testing endpoints.
Per GDPR specifications, VCT has established separate URLs for EU and non-EU customers.
Dev (US): https://dev.vctrials.com/ (note - only used by Foundry Health dev team)
Testing (US): https://qa.vctrials.com/site/index.aspx
Testing (EU): https://qa-eu.vctrials.com/site/index.aspx
Production (US): https://www.vctrials.com/site/index.aspx
Production (EU): https://www.vctrials.eu/site/index.aspx
Partner ID
The VCT interface partner ID is required per HTTP POST specification.
This value must always be set to ‘foundry-health’.
Study Configuration
Each study can enable or disable VCT support as needed.
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When this setting is disabled, VCT interactions will not be available on study over-volunteering forms.
Multi-site Studies
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 IQVIA support if there are any questions on how to best use the interface for that study.
Study Protocol Name
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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.
This value must always be set to ‘foundry-health’.
Study Configuration
Each study can enable or disable VCT support as needed.
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When this setting is disabled, VCT interactions will not be available on study over-volunteering forms.
Multi-site Studies
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 IQVIA support if there are any questions on how to best use the interface for that study.
Study Protocol Name
Each study in ClinSpark must have a defined protocol name to use as part of the interface. These settings can be applied by ClinSpark users with the proper role action to modify study protocol name.
This value must be an exact match the ‘protocol number’ value configured in VCT for the interface to work properly.
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Study Metadata & Over-Volunteering Form
An Over-Volunteering Base Form must be applied and appropriately configured as part of study metadata. This base form enables the use of the Over-Volunteering specialized workflow within the use of a study. Over-volunteering form settings can be reviewed by ClinSpark users with the proper role action to modify study protocol name.
This value must be an exact match the ‘protocol number’ value configured in VCT for the interface to work properly.
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Study Metadata & Over-Volunteering Form
An Over-Volunteering Base Form must be applied and appropriately configured as part of study metadata. This base form enables the use of the Over-Volunteering specialized workflow within the use of a study. Over-volunteering form settings can be reviewed by ClinSpark users with the proper role action to modify study metadata and study library forms.
ClinSpark comes with a Base Form Library that contains a standard Over-volunteering form. By default, the ‘Subject Over-Volunteering’ base form offers sensible defaults for sites to use as a starting point supporting the VCT integration. Sites can define their own Over-Volunteering Forms if they prefer as long as the Form and Items all appropriately contain the Over-Volunteer Base Types.
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As part of the default form, there are four items each with a ‘Over Volunteering’ base type associated that serve a function in the interface. Study and volunteer values are passed to VCT during the first part of the workflow, but when users are brought back to ClinSpark, there are over-volunteering details received from VCT which are attached to each of the items if the base types are associated. Here are those item base types:
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Over Volunteering - Result
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Over Volunteering - Report
metadata and study library forms.
ClinSpark comes with a Base Form Library that contains a standard Over-volunteering form. By default, the ‘Subject Over-Volunteering’ base form offers sensible defaults for sites to use as a starting point supporting the VCT integration. Sites can define their own Over-Volunteering Forms if they prefer as long as the Form and Items all appropriately contain the Over-Volunteer Base Types.
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As part of the default form, there are four items each with a ‘Over Volunteering’ base type associated that serve a function in the interface. Study and volunteer values are passed to VCT during the first part of the workflow, but when users are brought back to ClinSpark, there are over-volunteering details received from VCT which are attached to each of the items if the base types are associated. Here are those item base types:
Over Volunteering - Result
Over Volunteering - Report
Over Volunteering - Violations
Over Volunteering - Next Eligibility Date
Of the base types available for use on the form, two are considered non essential to the workflow and will not violate form lock conditions:
Over Volunteering - Violations
Over Volunteering - Next Eligibility Date
Of the Other base types available for use on the form, two are considered non essential to the workflow and will not violate form lock conditions:
Over Volunteering - Violations
Over Volunteering - Next Eligibility Date
Other base types (Report and Eligibility Result) are required at a minimum for the Over (Report and Eligibility Result) are required at a minimum for the Over volunteering form and the VCT interface to function properly.
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Volunteer demographics (Name, DOB, Sex) and the answer to custom volunteer questions (VCT ID values) must be present on volunteer records. These values (first three letters of First & Last name) are passed through to VCT during the workflow initiation.
These settings can be applied by ClinSpark users with the proper role action to modify volunteer profile data.
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to VCT during the workflow initiation.
These settings can be applied by ClinSpark users with the proper role action to modify volunteer profile data.
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User Permissions
In order for study users to utilize the interface in Over-Volunteering forms, their accounts must contain at least one role that includes use of specific role action called “VCT Support”. This role action allows for use of the VCT redirect features in Over-volunteering forms. Without this role action on user accounts, use of the VCT forms will not work.
https://foundryhealth.atlassian.net/wiki/spaces/DOCS/pages/3709239305/Role+Actions#VCT-Support
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Data Exchange
Message Exchange Workflow
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