CTMS Transfer automates the daily transfer of Study data between CRO and Sponsor Vaults, assuming both organizations use Veeva CTMS. This is most useful in situations where Sponsors contract with CROs to fully manage their Studies. CTMS Transfer simplifies data transfers between the CRO and the Sponsor Vault CTMS system and gives Sponsors read-only access to their trial data and CROs read-only access to Oversight Issue data, both updated daily.
The CTMS Transfer includes the following objects:
| Object | Sent From | Sent To |
|---|---|---|
| Study Country | CRO | Sponsor |
| Site | CRO | Sponsor |
| Subject | CRO | Sponsor |
| Subject Group | CRO | Sponsor |
| Study Country Subject Group | CRO | Sponsor |
| Study Site Subject Group | CRO | Sponsor |
| Metrics | CRO | Sponsor |
| Metrics Over Time | CRO | Sponsor |
| Enrollment Status Log | CRO | Sponsor |
| Issue | CRO | Sponsor |
| Milestone | CRO | Sponsor |
| Monitoring Event | CRO | Sponsor |
| Oversight Issue | Sponsor | CRO |
During transfer, Vault creates and updates records regardless of whether the associated object type is Active or Inactive in the target Vault. Vault also creates and updates records when users leave required fields blank in the target Vault. Vault does not run entry actions, entry criteria, validation rules, or event actions during transfer to help prevent unintended triggers.
Additionally, steady state, superseded, and obsolete Monitoring Documents transfer to the target Vault using the TMF Document document type. Obsolete documents only transfer if they were previously transferred as steady state or superseded.
Vault sets the External Transfer field of transferred records to Yes. These records are read-only and cannot be modified in the target Vault. Additionally, Vault only transfers standard fields and values. Records using custom picklist values, lifecycle states, or object types for in-scope fields must be mapped accordingly in the source Vault to transfer.
Vault sets the Deleted in Source System field to Yes on transferred documents and records that exist in the current Vault but have been deleted in the source Vault.
Note: Transferring a Milestone referenced as an Action or Inactivation event automatically starts or ends the corresponding Recurring Milestone Schedules in the target Vault.
Transfer Enablement
To use CTMS Transfer capabilities, an Admin must perform the following:
CRO Vault
- For in-scope objects, map any custom object types, lifecycle states, and picklist values to standard values via the Outbound Clinical Mapping UI. After this is done once at a system level, mappings apply to all transfers to all Sponsors and partners.
- Add the following fields to relevant page layouts:
- System ID - Protocol Deviation Sub Categories
- Standard Sub Category Mapping - Protocol Deviation Sub Categories
- Map custom Protocol Deviation Sub Categories to standard by populating the Standard Sub Category Mapping field on the custom record.
- In Admin > Connections, move Clinical Network Connection to the Active state.
- Establish an active Vault-to-Vault Connection with the Sponsor.
- Set up any necessary CDX Rule Overrides to filter out records from transfer.
- Send an Agreement to the Sponsor.
Sponsor Vault
- Add the following fields to relevant page layouts:
- External Transfer: All objects in scope of CTMS Transfer
- Deleted in Source System: All objects in scope of CTMS Transfer
- Source CRA - Monitoring Event
- Source Monitoring Event Type - Monitoring Event
- Source Milestone Type - Milestone
- Source Principal Investigator - Study Site
- Source Organization - Study Site
- Study Management Model - Study
- Source Category - Issue
- Source Subcategory - Issue
- For the Oversight Issue objects, map any custom object types, lifecycle states, and picklist values to standard values via the Outbound Clinical Mapping UI.
- Optional: Configure the Study Lifecycle so that entry actions do not execute for studies where Study Management Model equals Outsourced.
- Optional: Configure a Template Milestone Master Set for use with outsourced studies.
- In Admin > Connections, move Clinical Network Connection to the Active state.
- Establish a Connection to the CRO.
- Accept the Agreement.
CTMS Transfer Rule Set
The CTMS Transfer Rule Set sets the scope for transfer and determines what objects, fields, and values Vault transfers as a part of the Agreement. Veeva controls the Rule Set. You cannot modify or expand them, but you can constrain the Rule Set via CDX Rule Overrides. These allow CROs to specify additional criteria for a given rule which can be useful to prevent the transfer of records in a certain lifecycle state or with a specific field value. You can reuse CDX Rule Overrides across Agreements. You must add CDX Rule Overrides to an Agreement via a CDX Override Agreement before sending the Agreement to the Sponsor.
The CTMS Transfer Rule Set can support the transfer of steady state TMF documents in addition to the standard CTMS documents by selecting the Include TMF Documents checkbox on the CTMS Transfer Agreement. This selection prevents two separate CTMS Transfer and TMF Transfer agreements from running at the same time and simplifies the agreements process for Admin.
Note: Add the Include TMF Documents field to the CTMS Transfer Agreements page layout to view and select the field.
Outbound Clinical Mapping UI: Custom Field Mapping
The transfer scope is restricted to standard fields and values. You can transfer custom values if desired, but must map those custom values to standard values first. To do so:
- Navigate to Admin > Configuration > Outbound Clinical Mappings.
- From the Object Selection drop-down, select the relevant object.
- Expand the Custom Object Types, Custom Lifecycle States, or Custom Picklist Values section.
- Locate the custom field you wish to map on the Object, Lifecycle State, or Picklist.
- From the Standard Value Label drop-down, select the corresponding Standard Value Label to map to the Custom Value Label. Vault automatically fills the Standard Value Name field. Select the Do Not Map option if CTMS Transfer should ignore records using this custom value.
- Repeat these steps as needed.
Records using unmapped custom picklist values, lifecycle state, or object type will not transfer and a CDX Issue will be raised.
For detailed information about setting up connections between Vaults, see Managing Connections.
Accepting an Agreement
Vault creates the Approve Agreement workflow task in the target Vault and sends notifications to relevant users. Once a valid user clicks Accept, and then selects the Complete verdict on the task, Vault launches the Agreement wizard.
The wizard displays details about the agreement, including the requesting Vault and study. Clicking Next displays more detailed information about the study and allows the receiving user to map the study in the source Vault to an existing study in the target Vault.
The receiving user must click Complete and approve the agreement to activate the connection.
Transfer Maintenance
The Perform Clinical Transfer job initiates a transfer between CRO and Sponsor Vaults once per day. You must select the Schedule Transfer field in the Details section of the CTMS Transfer Agreement for the Perform Clinical Transfer job to run daily. If you do not select the Schedule Transfer, a source Vault Admin must manually initiate the transfer. Only items updated since the last transfer are included. Each transfer generates an Agreement Transfer record that logs the start and finish time of the transfer.
- CDX Issues - CRO & Sponsor
- Resolving CDX issues - CRO & Sponsor
- Deactivating agreement - CRO
- Pausing Agreement - CRO
- Activity log - CRO & Sponsor
Note: Add the Schedule Transfer field to the CTMS Transfer Agreements page layout to view and select the field.
Vault times out Agreement Transfer records that remain in the Extracting state for more than 24 hours and transitions the record to the Finished state.
CDX Issues
When an agreement is unable to process a rule, Vault creates a CDX Issue record in the Vault where the error must be resolved. There are four CDX Issue Types that Vault may create:
- Record Mapping Issue: Vault creates this issue type when a required mapped record does not exist.
- Document Configuration Error: Vault creates this issue type when a mapped document type is missing.
- Server Error: Vault creates this issue type when there is an error not related to object record mapping, document type mapping, or Vault configuration.
In addition to other details, each issue record has a detailed Error Message field to inform you of what actions need to be taken. For example, if a required mapped record does not exist, the Error Message field would read: “No record with mapping record or matching Link field exists.”
Resolving CDX Issues
With every Issue record that Vault creates, it also creates a workflow that allows you to resolve the issue. The workflow for resolving an issue depends on the issue type.
Object Configuration Error Types
Selecting Run Associated Rule from the Actions menu attempts to process the failed rule again. Before selecting the action, you must resolve any configuration discrepancies.
Deactivating an Agreement
You can deactivate an agreement in two ways:
- As a user in the target Vault, select the Reject verdict on the Approve Agreement workflow task.
- For an Active or Pending agreement, select Deactivate Agreement from the Actions menu. You cannot reactivate a deactivated agreement.
Pausing an Agreement
If you need to suspend an agreement for any reason, you can do so with the Pause Agreement action available on active Agreement records. Pausing an agreement moves the record to the Paused lifecycle state in both Vaults.
You can unpause an agreement with the Unpause Agreement action. This returns the agreement to the Active lifecycle state.
Activity Log
Vault captures activities related to the transferring and receiving of object records and documents using the Agreement Activity object.
Vault marks the Direction field on the Agreement Activity record as Outgoing or Incoming depending on whether the object record or document was sent or received.