Veeva Disclosures allows sponsors to centralize and streamline the clinical disclosure management process by accelerating registry submissions and improving compliance across global regulations. Each Disclosure record must have an associated Registration record and, optionally, a Protocol record.
Note: Veeva Disclosures is an add-on application to Veeva CTMS and part of the Clinical Operations application family. You must have Veeva CTMS and Veeva eTMF to use Veeva Disclosures. Contact your Veeva representative for more information.
Creating Registrations
To create Disclosure records for a Study, you must have a Registration record for the registry you will submit the Disclosure to. A Study record can only have one Registration record for a supported registry. While a Study only has one Registration record per registry, each Registration record displays all Disclosures generated for a Study for the specified registry.
To create a Registration record:
- Navigate to the Registrations tab.
- Click Create.
- Select a Registration Type from the drop-down and click Continue.
- In the dialog, select a Study.
- Optional: Select a Study Country.
- Optional: Enter the Registry Trial Identifier.
- Select a Disclosure Scope from the drop-down menu. Registration only allows Vault to automatically generate Registration type Disclosure records. Registration and Results allows Vault to automatically generate Registration and Results type Disclosure records. Vault does not automatically generate any type of Disclosure records when you select Not Disclosed.
- Optional: Select a Reason for Disclosure.
- Optional: Enter a Reason for Disclosure Comment.
- Click Save.
Once you create the Registration record, you can create a Disclosure.
Creating Protocols
The Protocol object allows you to save time and improve efficiency by capturing key study protocol details, tracking changes between protocol versions, and populating consistent data into all Disclosure records for a study.
To create a Protocol record:
- Navigate to the Protocols tab.
- Click Create.
- Select a Study to associate the record to.
- Enter a Name.
- Optional: Complete any other desired fields.
- Click Save.
You can view Protocol records in the Protocol tab or in the Protocol section of associated Study records, when configured.
You can fill out several optional fields when creating or editing Protocol records, such as the Protocol Document field. The Protocol Document field allows you to link existing protocol documents in Vault.
Once you create a Protocol record, you can create a new Disclosure record referencing the Protocol. When you select a Protocol record for a new Disclosure record, upon creation, Vault prepopulates the new Disclosure record with data from the Protocol record.
Note: Data in Protocol records data will only populate into US Protocol Registration disclosures.
Selecting the Copy Entire Protocol action duplicates an existing Protocol record, including all linked items and translated records. Any fields populated from the selection of records on the Protocol remain the same when the records are updated on a copied Protocol.