Configuring for TMF Transfer (eTMF)

This article describes the configurations that Admins must perform in Vaults participating in data transfer via TMF Transfer.

Configuration Overview

1. In both Vaults, add a Related Object section for the Agreement object to the Study Detail Page Layout on the Study object.
2. In both Vaults, add Related Object sections for Agreement Transfers and Transfer Failures on the Agreement object page layout.
3. In both Vaults, map document types to the TMF Reference Model 3.0.
4. In the target Vault, configure the TMF Exchange Document Lifecycle to include custom roles. Or, replace it with a custom lifecycle.
5. Optional: In the target Vault, create Field Default records if either Vault has set required fields on Base Documents that are not included in TMF Documents.
6. Optional: In the target Vault, create Configuration Mapping records to map components that have different names in each Vault.
7. Optional: In both Vaults, import and deploy layout changes and notifications.
8. In both Vaults, assign permissions to users.
9. Establish a Vault to Vault Connection between the source and target Vaults.
10. In both Vaults, assign Connection Users to the Connection.
11. Optional: Activate rule sets.
12. Optional: Enable Document Archive in both Vaults to properly transfer archived documents.
13. Optional: Enable Study Archival in both Vaults to properly transfer Study Country and Study Site records related to archived studies.

Map Document Types

You should ensure that document types that you want Vault to transfer are included on the TMF Reference Model v3.0. To do this:

1. Navigate to Admin > Configuration > Document Types.
2. Select a document type and click the Type Defaults tab.
3. Under TMF RM v3.0, select the document type, then click Save.

This mapping determines how Vault populates the Source Artifact (source_artifact__v) field in the target Vault. This allows the target Vault to view these documents in the TMF Viewer.

Configuring Document Lifecycles

Vault provides the standard TMF Document document type and TMF Exchange Document Lifecycle to support TMF transfer. Depending on the needs of your organization, you can either:

• Add custom roles to the standard TMF Exchange Document Lifecycle.
• Remove the TMF Exchange Document Lifecycle from the TMF Document document type and add a custom lifecycle.

Field Defaults

Field Defaults allow you to specify a default value to apply to certain fields on incoming documents and object records. For example, if your Vault contains custom required fields on the Base Document type in addition to the standard TMF Document fields, Vault will not transfer documents to your Vault because those fields do not exist in the source Vault for TMF Documents. For that scenario, create a Document Field Default type of Field Default to apply that field and default value to incoming documents for all Agreements associated with a specific Connection.

You can apply Field Defaults to all Agreements associated with a specific Connection or a specific Rule Set. To create a Field Default record:

1. Create a Field Default record from Business Admin or a custom tab.
2. Select a Field Default Type and click Continue.
3. Enter a Name, Field Name, and Default Value to apply. Note that Default Values must be entered in a specific format. For Object Field and Object Field Default (Rule Set) types of defaults, enter an Object Name.
4. Depending on the Field Default Type you are creating, select the Connection or Rule Set that this default value will apply to.
5. The Status defaults to Active on new records. You can change the status to Inactive if you want Vault to ignore the Field Default.
6. Click Save.

If you create both Rule Set-level and Connection-level Field Defaults for a field, Vault applies the Default Value specified in the Connection-level Field Default Type.

Default Value Formatting

You must enter values in the Default Value field in the correct format:

Data Type	Format
Text	Text
Yes/No	True/False
Object	Object ID
Date Time	YYYY:MM:DDTHH:MM:SS.MMMZ
Date	YYYY:MM:DD
Picklist Value for Object	Picklist Value Name
Picklist Value for Document	Picklist Value Label
Number	123

To have Vault use the prior version’s value for the field, use the {prior_version_value} token. This will automatically fill in whatever value was in that field on the previous version of the document.

Configuration Mapping

Configuration Mapping records allow you to map data in your target Vault to data with a different name in the source Vault. For example, if the standard Content (blinding__v) field is inactive in either Vault in favor of a custom field, the field may not be set correctly on transferred documents. To avoid this, create a Document Field Name type of Configuration Mapping to map the standard field name to the custom field name.

Types of Configuration Mapping

• Document Field Name
• Document Type
• Object Field Name
• Object Name
• Picklist Value

How to Create Configuration Mapping Records

1. Create a Configuration Mapping record from Business Admin or a custom tab.
2. Select the mapping type and click Continue.
3. Enter a Name and Incoming Name. The Incoming Name must match the name from the incoming Vault. For Object Field Name and Object Type Name types, enter an Object Name Mapping Rule. For Picklist Value type, enter a Local Picklist Name.
4. Optional: Enter a Local Name that matches the name in your Vault. If you do not enter a value in the Local Name field, the incoming record will not be populated with the value from the source Vault.
5. Select the Connection that this mapping will apply to.
6. Click Save.

Configuring Layouts

We recommend that you add additional page layout sections for the Agreement, Connection, and CDX Issue objects to make the objects more usable. To do this, import and deploy a Configuration Migration Package:

1. Download the VPK file here.
2. Extract (unzip) the downloaded file.
3. Import and Deploy the package in your Vault.

Configuring Notifications

We recommend that you add two additional notifications to the CDX Agreement lifecycle so that Vault notifies users in both Vaults when an Agreement is activated. To do this, import and deploy a Configuration Migration Package:

1. Download the VPK file here.
2. Extract (unzip) the downloaded file.
3. Import and Deploy the package in your Vault.

Establishing a Connection

You must create a Vault to Vault Connection between the two Vaults that will transfer data. For detailed information about setting up connections between Vaults, see Managing Connections.

Configuring Connection Users

You can specify which users receive tasks related to all Agreements linked to a specific connection. This requires that you first update the Connection object in one of the following ways:

• Deploy the Configuration Migration Package file to update page layout changes for the Connection object. See details above.
• Add a related object section to the Vault to Vault Detail Page Layout on the Connection object for the CDX Connection User > User object.

To specify users to receive tasks:

1. Navigate to Admin > Connections and click into the Connection.
2. In the User section, click +Add.
3. Select the relevant users.
4. Click OK.

Activating Rule Sets

Veeva provides several rule sets to support TMF Transfer:

• Simple TMF Transfer Blinded
• Simple TMF Transfer Blinded (No Site Creation)
• Simple TMF Transfer Complete
• Simple TMF Transfer Complete (No Site Creation)

The Simple TMF Transfer Complete rule set is active by default. You can activate additional Rule Sets via a Vault Owner or through a support ticket.