Summary

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

An overview of the functionality can be seen here.

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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.

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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.

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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:

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