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Here is an overview of onboarding from an instance standpoint:
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Demo instance is for Foundry Health to demo ClinSpark in ‘branded’ environment to a potential customer.
Sandbox instance pair is created for customers upon contract signing, and used for a wide variety of activities that includes training, informal testing, and continued feature exploration.
Migration environment is used to present the output of volunteer database migration iterations for review by customers. Migration contributes to all volunteer configuration, including most things under the Volunteers > Configure module.
VAL instance pair is created to support formal validation activities. The VAL instance pair is created by combining the general configuration of the source instance selected by the customer (Sandbox or prePROD instance) with the output of the migration program.
PROD instance pair is created by combining the general configuration predefined by the customer for this instance or coming from VAL with the output of the migration program.
Community Dev is a shared environment Foundry Health makes available to all customers, with the purpose to explore latest ClinSpark release functionality at any time. It is available for use during and after onboarding phases, but typically, customers explore ClinSpark in their own Demo and Sandbox instances first. More details are on our Community page.
Demo Environment
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Environments as Pairs of Instances
ClinSpark environments are provisioned in pairs, unless otherwise stated. These pairs are referred to as ‘Main’ and ’Test'.
There will be a Sandbox pair, a Validation pair and a Production pair. Exceptions are Demo, Pre-PROD, Migration and Community Dev, which are all provisioned as single instances.
Environment | Pair | Longevity | Controlled / IQ’d |
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Demo | No | Persistent | No |
Sandbox | Yes | Ephemeral | No |
Migration | No | Ephemeral | No |
Validation | Yes | Ephemeral | Yes |
Pre-PROD | No | Ephemeral | Yes |
Production | Yes | Persistent | Yes |
Community | No | Persistent | No |
Demo
A single environment that is first used by IQVIA to demonstrate ClinSpark to a prospective customer. Multiple versions of demo may exist, each with a different version of ClinSpark installed.
Customers are not typically given access to Demo environments.
Demo environments are not controlled environments and do not receive IQ documentation.
Sandbox
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Once a customer signs a contract, the Sandbox pair is created. Depending customer preference, Sandbox can either be a brand new ‘empty’ instance pair or a clone of Demo instance in order to preserve data and configurations already familiar from the Demo instance.
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A pair of disposable instances is created for customers upon contract signing, and used for a wide variety of activities that includes training, informal testing, and continued feature exploration. Once in production, the sandbox pair will be destroyed. Sandboxes are not controlled do not receive IQ documentation. IQVIA may update and amend them without notice.
Sandboxes come complete with some base configuration out of the box and a sample of ’dummy’ volunteers.
Sandbox environments are destroyed once PROD goes the customer is live. For continued feature exploration of the latest release, customers are expected use the Community Dev environment.
Sandbox environments do not receive IQ documentation.
Appropriate Sandbox instance activities:
Training
Feature Exploration
Early Study Design
Informal Testing
Day-run Formal Testing
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ClinSpark does not support a mechanism to |
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copy study libraries from Sandbox and import them into other environments. While early study design activities may take place in Sandbox, efforts to establish master libraries and CRF Design elements intended for a PROD environment should take place in the Pre- |
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PROD instances once available. If customers need to take basic CRF design elements from Sandbox into other environments, they should consider use the CDISC ODM XML study design file export/import feature. |
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What passes from Sandbox to VAL and PROD, if Sandbox is defined as the source instance
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Administration > Roles
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Administration > Sites (Note that archived sites are not passed)
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Administration > General Settings (except when this is integration-specific such as with SSO)
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Administration > Medical Dictionaries
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Devices
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Labs, Panels, Lab Tests
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Barcode Label Configurations
Migration
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Migration
This single disposable instance is created for customers whose source database will be migrated to ClinSpark. This instance exists solely for the purpose of presenting
It is used to present the output of the the volunteer database migration logic iterations for review and QC by the customer. It is a single instance, and only the main instance is provided to support this activitycustomers. The migration instance is used for formal acceptance testing of the migration scripts. Migration contributes to all volunteer configuration, including most things under the Volunteers > Configure module.
The Database Migration process is described elsewhere in our documentation.Changes
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Customer / superadministrator changes to the Migration instance will not be preserved. |
Any intended configuration updates to the Migration configuration such as medical history dropdownsdrop-downs, etc. must be made to the detailed in the Migration Specification our source database and be implemented by way of the migration process itselfwhere applicable and made in Pre-PROD.
The Migration instance is destroyed once the migration outputs scripts are signed off on approved by the customerscustomer.
The Migration environment does is not a controlled environments and do not receive IQ documentation.
Appropriate Migration instance activities:
Evaluation of the output of the migration program
What is passed from Migration to VAL and PROD
All Volunteers
Archived studies, created to support historical study participation
These Volunteer > Configure elements:
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VAL (Validation) Pair
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Validation
Validation (‘VAL’) is offered as a pair of formal environments to support a customer’s platform validation activities. This environment will be produced with the general configuration from the source instance selected by the customer PLUS the migration output. Note that this is effectively a dry run of the same mechanism used to create PROD.
Volunteer PHI is obfuscated in the VAL environment.
If required, informal versions of VAL can be created to support early activities such as test creation or QA prior to the creation of the final VAL instances
The VAL instance pair is created by cloning the full and final configuration of the ClinSpark source instance (Pre-PROD). Having a pair of instances for VAL allows customer to execute the full study build, test and publish lifecycle, as it would be intended in production.
VAL is destroyed after validation is completed and PROD the customer goes live. A fresh VAL pair is created the next time the customer needs to perform platform validation.
VAL environments are controlled environments and receive IQ documentation.
Pre-PROD
You may think of this as ’staging’. This is a single instance of ClinSpark.
During platform exploration in Sandbox you will reach decisions on your intended and required configuration to support the migration of participant data from your legacy solution and to support your business operations - how you conduct your trials. As you make these decisions, the configuration in Pre-PROD
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These are customer production instances. After “go-live” these instances remain as is until upgrading.
PROD environments receive IQ documentation.
PROD “go-live” steps
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Customer: provide FH with final source DB dump/files and any other related files.
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FH: extract configuration from the source ClinSpark instance agreed upon by the customer
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FH: run the migration program to produce the new ClinSpark instance
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FH: populate, configure, review the final PROD Main instance
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FH: provide formal IQ documentation
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will need to be updated.
You will also be developing study design elements (forms etc.) in Sandbox that you intend to use in production. We recommend that your master library of forms be re-created in Pre-PROD. We provided some tips above on how to do that.
This is important as Pre-PROD will be cloned to make VAL and we recommend that the master library be included in that process.
Production
Production (‘PROD’) instances come as a pair.
The PROD ‘main’ instance is created by promoting Pre-PROD at the time of the participant database migration from the customer’s legacy system. The ’test’ partner to ‘main’ is created directly after.
PROD environments are controlled environments and receive IQ documentation.
Training
We typically see that customers will train staff and customer users (monitors, CRAs etc) in PROD Test. This environment does not contain any real participant information or any real trial data - only dummy data.
Once users are ’signed-off’ in Test, they can provided appropriate access to Main according to their role.
Community
Also known as ‘Community Dev’ - a shared environment IQVIA makes available to all customers, with the purpose to explore latest ClinSpark release functionality at any time. It is available for use during and after onboarding phases, and replaces the customer sandbox instance once the customer is live.
More details are on our Community page.
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