CTMS Transfer

CTMS Transfer automates the daily transfer of Study data from a CRO Vault to a Sponsor Vault, assuming both organizations use Vault 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 updated daily.

The transfer includes the following objects:

  • Study Country
  • Site
  • Subject
  • Subject Group
  • Study Country Subject Group
  • Study Site Subject Group
  • Metrics
  • Metrics Over Time
  • Enrollment Status Log
  • Issue
  • Milestone
  • Monitoring Event

During transfer, Vault creates and updates records regardless of whether the associated object type is Active or Inactive in the target Sponsor Vault. Vault also creates and updates records even when required fields in the Sponsor Vault are left blank by the CRO. Vault does not run entry actions, entry criteria, 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Additionally, steady state, superseded, and obsolete Monitoring Documents transfer to the target Vault using the TMF Document document type. Obsolete documents only transfer if they were previously transferred as steady state or superseded.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, only standard fields and values are transferred. Records using custom picklist values, lifecycle states, or object types for in-scope fields must be mapped accordingly in the CRO Vault to transfer.

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.
  • 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 Principal Investigator - Study Site
    • Source Organization - Study Site
    • Study Management Model - Study
  • 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 are transferred as a part of the Agreement. The Rule Set is controlled by Veeva and cannot be modified or expanded, but can be constrained 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. CDX Rule Overrides can be reused across Agreements. They must be added to an Agreement via a CDX Override Agreement prior to sending the Agreement to the Sponsor.

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:

  1. Navigate to Admin > Configuration > Outbound Clinical Mappings.
  2. From the Object Selection drop down, select the relevant object.
  3. Expand the Custom Object Types, Custom Lifecycle States, or Custom Picklist Values section.
  4. Locate the custom field you wish to map on the Object, Lifecycle State, or Picklist.
  5. From 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.
  6. 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 CTMS Transfer job will initiate a transfer from the CRO Vault to the Sponsor Vault once per day. Only items updated since the last transfer will be 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

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.

Record Mapping Issue & Document Configuration Error Issue Types

Create Record or Map to Existing are special user actions under the Actions menu on the Issue record.

  • If you select Create Record, Vault takes you to the record or document type creation page. Once created successfully, the mapping issue will move to the Resolved state.
  • If you select Map to Existing, Vault creates a record with the ID of the record that triggered the issue.

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.