About Medidata CTMS Integration (eTMF)

The Medidata CTMS Integration feature provides an integration between Veeva Vault and Medidata CTMS. When organizations use this feature, Medidata CTMS serves as the source for Study, Study Country, Study Site, and Location data in an eTMF Vault. In addition to syncing object data records, the integration can also automatically sync approved visit reports from Medidata CTMS.

How the Integration Works

Data and document syncing happens automatically, with Medidata CTMS “pushing” updates to Vault on a regular basis. By default, this sync happens hourly. A manual option is also available in Medidata CTMS, allowing users to trigger a sync immediately when needed. Vault users should know that changes they make in their Vault (to document fields on visit reports or object data records) can be overwritten when Medidata CTMS pushes new data into the Vault.

Any actions on the Vault side that happen as part of syncing are attributed to a specific Vault user specified during setup. We refer to this user as the “integration user.”

Integration Setup

The initial setup process for Medidata CTMS Integration involves steps that must be completed in Vault and in your Medidata CTMS instance. We recommend that you contact your Veeva representative for assistance with this process.

Using Data Record Syncing

Data record syncing can create or update object data records for the Study, Study Country, Study Site, and Location objects. During sync, Vault populates a specific set of object fields with details from Medidata. This field set varies by object.

Study Fields

Study Number (name__v)
Status (status__v): Defaults to Active
Study Status (study_status__v): Matching picklist value must exist in the Vault
Study Phase (study_phase__v): Matching picklist value must exist in the Vault
External ID (external_id__v): In subsequent syncs, this identifies studies sourced from CTMS

Study Country Fields

Study Country Name (name__v): Uses the Name field name from the related Country record
Status: Defaults to Active
Country (country__v): Uses the country value in the site’s primary location address from CTMS to find the corresponding country record in the Vault, with match on abbreviation as described below
External ID (external_id__v): In subsequent syncs, this identifies study countries sourced from CTMS

Study Site Fields

Study Site Number (name__v)
Status (status__v): Defaults to Active
Location (location__v): Uses the primary address value from the study site’s primary location address in CTMS to find the corresponding location record in the Vault (with match on External ID)
External ID (external_id__v): In subsequent syncs, this identifies study sites sourced from CTMS

Location Fields

Location Name (name__v): Uses the study site’s primary location value from CTMS
Status: Defaults to Active
Country (country__v): Uses the country value in the site’s primary location address from CTMS and looks for a match in the Country object’s Abbreviation field. Abbreviations in the Vault should follow the ISO 3166 Alpha 3 standard.
External ID (external_id__v): In subsequent syncs, this identifies locations sourced from CTMS

About Visit Report Syncing

When Vault syncs visit reports, they become Approved state documents with the default MVR from Medidata CTMS lifecycle. Vault applies a naming convention using data from Medidata: {Monitoring Visit Type} {Visit Name} {Visit Date}. The specific document types applied to synced visit reports are defined in the mapping file in Medidata CTMS. There is no special behavior applied to these documents after syncing. If the visit report is updated and re-approved in Medidata CTMS, the integration will automatically version and re-approve the document in Vault.

Synced Document Fields

Medidata CTMS Integration syncs the following document fields for visit reports:

Study (study__v)
Study Country (study_country__v)
Study Site (site__v)
CTMS External ID (ctms_external_id__c)

MVR from Medidata CTMS Lifecycle Configuration

Vault does not prevent you from modifying the standard MVR from Medidata CTMS lifecycle, but certain elements must exist to ensure that the document sync works properly:

Lifecycle Details	Lifecycle name must be `mvr_from_medidata_ctms__c`.
States	The starting state must be called Under Revision and this state must be active.
States	The steady state must be called Approved and this state must be active.
States	The superseded state must be called Superseded and this state must be active.
State Security Settings: Under Revision	The Owner role must have View Document, Edit Document, Change State, and Delete permissions.
State User Actions: Under Revision	A state change user action rule must exist to move the document into Approved state. The action label must be Approve.
State Security Settings: Approved	The Owner role must have View Document, Edit Document, Version, and Delete permissions.
State Entry Actions: Approved	Entry action rules must be configured for Always set new major version, Always set previous steady state to superseded, and Always delete minor versions.

Document Type Configuration

Any document types can be used for visit reports, but the integration user must be granted Create Document permission on these document types and they must use the MVR from Medidata CTMS lifecycle.

To ensure that newly created Visit Report documents are available to the correct set of users, an Admin can configure default users that Vault will put into document roles when the document is initially created.