Using TMF Export, you can create transferable packages of TMF documents, metadata, and audit trails for individual Study records. These packages simplify sharing study data with Sponsors and organizations, particularly those not using Veeva eTMF.
Configuration Overview
- Add the Export TMF Package action to the Study object.
- Optional: Use atomic security to ensure only authorized personnel can initiate a study-level export action.
- Optional: Create or edit reusable export templates with the TMF Export Configuration object.
Creating TMF Export Configuration Templates
TMF Export Configuration records allows you to define the available Lifecycles, Lifecycle States, Available Rendition Types, and Attachment Types a user can select when generating a TMF Export Package and select the default toggle settings for additional values.
You do not have to create a TMF Export Configuration to use the TMF Export feature. Veeva provides the Standard TMF Export (standard_tmf_export__v) records as a standard export configuration template for Vaults with the Base Doc Lifecycle (clinical_doc_lifecycle__c). Admin can edit the existing Standard TMF Export or create new records as needed.
To create a new TMF Export Configuration record:
- Navigate to Admin > Configuration > Application Configuration > TMF Export Configurations.
- Click Create.
- Enter a Name for the record.
- Select Lifecycles values. Only documents associated with the selected lifecycles will be included in the export.
- Select Lifecycle States. The lifecycle states values limit the documents available for TMF Export.
- Select Available Rendition Types. The rendition type values allow you to limit the documents available for TMF export.
- Optional: Select default toggle settings for additional fields.
- Click Save.
Once saved, users can select the new configuration record when running the Export TMF Package action on a Study record.