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Developer Features in 25R3

We are pleased to bring you the following additions and enhancements to EDC & CDB Developer features in 25R3.

EDC API v25.3

EDC API features added in 25R3 only affect API v25.3, unless otherwise specified.

Manage Protocol Deviations

Release Date: August 22, 2025, 25R2.2 Limited Release NEW

Four new endpoints allow you to manage protocol deviations in EDC via API.

Retrieve Protocol Deviations

You can retrieve:

Create Protocol Deviations

You can create protocol deviations:

Update Protocol Deviations

The Update Protocol Deviations endpoint supports full or partial updates to deviations.

Inactivate Protocol Deviation

The Inactivate Protocol Deviation endpoint inactivates with a specified change_reason or with the default, which is "Action performed via the API."

Support for Minimum Number of Repeating Forms

Release Date: August 22, 2025, 25R2.2 Limited Release UPDATE

To support the new configuration for study builders to set a minimum number of repeating forms, the following endpoints have been adjusted:

Update Event & Set Event Date

For any form in an event referenced by the Update Event or Set Event Date endpoints that has a minimum number of repeating forms configured, the first repeat of the form will now be automatically created for the event.

Retrieve Form Definitions

The Retrieve Form Definitions endpoints will now return the repeat_minimum parameter.

Casebook Design Export (CDE)

The CDE will be updated with the following new parameters for form_def: * repeat_minimum (on schedule and form level) * override_repeat_minimum (on schedule level) * override_repeat_maximum (on schedule level)

Start and Manage Vault-Level Jobs

Release Date: Oct 3, 2025, 25R2.3 Limited Release NEW

The following new vault-level endpoints allow you to manage vault-level jobs:

The respective endpoints show analogous behavior to study-specific job management endpoints, such as those used for listings or audit trail retrieval.

Additionally, EDC vault-level jobs can now be started with the Start Job (vault-level) endpoint using the user_access_report__vand user_training_report__v parameters:

New Endpoint for User Activation

Release Date: Oct 2, 2025, 25R2.0.21 Maintenance Release NEW

In some cases, the Activate User - Vault(s) API endpoint can reactivate non-VeevaID site user accounts. This bypasses new validations that were implemented to ensure a consistent site user experience. In this release, we address this issue by updating the user activation logic and providing a new URL for the Activate User - Vault(s) API endpoint. This endpoint is the recommended method for activating inactive accounts for both site and sponsor users.

CDB API v25.3

CDB API features added in 25R3 only affect API v25.3, unless otherwise specified.

Study File Format (SFF) Package Versioning

Release Date: Oct 3, 2025, 25R2.3 Limited Release NEW

The new 25.3 version of the Study File Format (SFF) API allows customers to define if they want the system to generate the 1.0 or 2.0 SFF package version. Changes to the package version will require a new full SFF package generation. A study cannot use multiple versions at the same time but can change from one version to another.

It is possible to set the package version for all studies within the vault and then individually set a study to a different version if needed. If a package version is set for a study, this overrides the vault-level package version.

There are five new endpoints to support package versioning:

Currently, the difference between 1.0 and 2.0 is the inclusion of deduplicated columns in the 2.0 version. If an export does not want column deduplication, they can set the package generation to the 1.0 package version.

Study File Format (SFF): Ensuring Consistent Form Submit Dates

Release Date: Oct 3, 2025, 25R2.3 Limited Release UPDATE

Third-party data extracts included in the SFF will now populate the form last submit date in the SYS_FORMS CSV file. This feature ensures that the form last submit date in the SYS_FORMS CSV file is consistent with the clinical data for all third-party data extracts within the SFF.