Summary

ClinSpark version 1.5.0 introduced an integration with the Medidata eConsent platform.

An overview of the functionality can be seen here.

Prerequisites

• Access to the Volunteers > eConsent component and features are granted via role action ‘Volunteers eConsent’.

• ClinSpark customers must manage their own Medidata eConsent accounts

Workflow

Users will define an eConsent vendor (Medidata) to be associated with a given study specific informed consent configuration. This selection will prevent users uploading a PDF file with that configured ICF.

Open

Once an eConsent ICF configuration has been established, ClinSpark will define a URL to be provided with eConsent provider for configuration in external system.

Open

Depending on how the eConsent platform is used, ClinSpark users may be required to view and interact with the unique 2d barcode associated to a given study volunteer. This barcode is unique to each volunteer record in ClinSpark and ideally used in workflows to match a given eConsent with a study subject. The barcode is made visible to users via the Action menu while viewing the volunteer profile (Volunteers > Manage).

All inbound eConsent requests for a given study can be reviewed in the Volunteers > eConsent component. Users will review and approve inbound requests across studies that would come by way of Medidata.

Inbound consent requests are automatically matched with existing volunteers if there is an exact match using volunteer First Name, Last Name, DOB, and Sex. Additionally, exact match can occur if the volunteer ID is received from Medidata using the ClinSpark 2d barcode.

If there is not a volunteer match, users are able to update the eConsent request and assign a volunteer.

Once an inbound eConsent request has been matched with a volunteer, users can proceed with standard ICF collection workflows in the Study > Subjects component. These workflows are similar to that of standard ICF. Users will be required to select an appropriate eConsent ICF version on the form and the date of consent will automatically be assigned.

Testing

ClinSpark offers an eConsent testing API that can be used to create ‘fake’ requests into a customer environment. This can be used to simulate inbound requests to test or perhaps demonstrating workflows. Use of the API assumes the following:

• ClinSpark user account that contains ‘API’ role action

• Customers establish their own SwaggerHub account

• API is used for testing / demo purposes only, and not for validation of functionality for production use

If customers want to test and/or validation the eConsent functionality for use in a production setting, the actual Medidata eConsent platform should be used to establish inbound requests. Customers are encouraged to work with Medidata on those testing requirements to gain access to appropriate environments and test accounts from Medidata.

The public API is available here: https://app.swaggerhub.com/apis/brock57/Medidata_eConsent/1.0.0

The following screencast demonstrates use.