# Auto-Filing Study Training Logs to eTMF

Training records captured in Study Training Vaults are key trial artifacts relevant to an organization's trial master file in Veeva eTMF. To support this relationship and eliminate manual processes for filing training records to eTMF, Study Training Vaults can automatically generate and store both site and trial team training reports (logs) as Library documents, then transfer them to eTMF as CrossLinks.



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      <p><strong>Note</strong>: This feature is available in <a href="/en/lr/54469208/">connected</a> Study Training and eTMF Vaults only, and must be configured by a Vault Admin.</p>
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## How Vault Auto-Files Study Training Logs to eTMF

Study Training Vaults include two standard multi-pass reports, _Matrix Assignments: Site Evidence of Training_ and _Matrix Assignments_: _Trial Team Evidence of Training_. These are the Veeva-recommended reports, however your organization may use a [custom report][2].

When the _Send Training Evidence to eTMF_ action is initiated from a _Study_ record as an entry action or user action, Vault:

* Runs the Study Training report and files the output under the corresponding Study Training [document type][1].
    * Vault manages the document according to its configured lifecycle. When configured to use the Veeva-recommended _Draft to Approved_ lifecycle, Vault automatically transitions the document to its _Approved_ (Steady) state.
    * Similar to the above, when the action is run multiple times for a given study and an eTMF CrossLink already exists, Vault up-versions the existing document and transitions it to its configured Steady state.
    * Vault uses the _Generate Document From Report_ SDK job to generate and file the report output. This job fails when the intended document type's lifecycle is not configured with a Steady state type.
    * Training Admins and others with access can also view the reports at any time under **Reporting & Dashboards**.
* Initiates the Study Training Vault's _Send Study Training Reports to eTMF_ SDK job. This prompts the Study Training-Clinical Operations Connection to send the document to the eTMF Vault as a CrossLink, via the connection's _Study Training Materials Outbound Integration Point_.
* Once received by the eTMF Vault's _Study Training Materials Inbound Integration Point_, Vault files the report output document CrossLink under the corresponding eTMF [document type][1].



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      <p><strong>Note</strong>: This feature requires that any Vault-generated documents remain in their Steady state. It is important that these documents are not obsoleted or retired in the Study Training Vault.</p>
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### Default Document Types  {#default-document-types}

By default, this feature references the below Study Training and eTMF document types to store training report output documents. Vault determines the appropriate eTMF document types based on the inbound Integration Point's target key, which a Vault Admin can update to map to different eTMF document types.

* Study Training standard document types:
    * _Trial Team Evidence of Training_ (`trial_team_evidence_of_training__v`)
    * _Site Evidence of Training_ (`site_evidence_of_training__v`)
* eTMF custom document types:
    * _01 Trial Management_ (`trial_management__c`) > _Meetings_ (`meetings__c`) > _Trial Team Evidence of Training_ (`trial_team_evidence_of_training__c`)
    * _Site Management_ (`site_management__c`) > _Site Initiation_ (`site_initiation__c`) > _Site Evidence of Training_ (`site_evidence_of_training__c`).


## Configuration Overview

To configure Vault to Auto-File study training logs to eTMF, follow the steps below. This configuration should be completed in your Study Training Vault, unless otherwise indicated.

1. Review your Vault's document type and lifecycle configuration in **Admin > Configuration > Document Types**. For each of the [default document types][1] Vault uses to store Study Training reports:
    * Select **Edit Details** for the document type. In the **General** tab, update the **Status** to "Active".
    * In the **General** tab's **Available Lifecycles**, select the lifecycle you'd like to use for the report output. By default, the Veeva-recommended _Draft to Approved_ lifecycle appears in grey, however you must re-select this or another lifecycle so that it appears in blue.
2. Navigate to **Admin > Configuration > Document Lifecycles**. For the lifecycle selected in Step 1, ensure:
    * There is a state mapped to the lifecycle's **Steady State** type. This is required to ensure the standard _Generate Document From Report_ SDK job can create and file the report output.
    * It is not possible to obsolete or retire the Vault-generated output document using the selected lifecycle. This feature requires that any such Library documents remain in their Steady state.
3. Navigate to **Admin > Configuration > Objects**. Within the **Study** object, create an action using the standard _Send Training Evidence to eTMF_ action.
    * During configuration, ensure you **do not** select the _Available in All Lifecycle States_ option. To resolve this, simply delete the action and re-create it.
    * When this configuration is enabled, you cannot select any reports when configuring the action within the _Study_ object lifecycle as described in Step 4. Additionally, if left unaddressed, Vault defaults to sending the standard reports in all _Study_ lifecycle states.
4. Navigate to **Admin > Configuration > Object Lifecycles**. Within the **Study Lifecycle**, select the lifecycle state for which you'd like to send the reports via entry action. While you can select one or more lifecycle states, we recommend using the _Closing_ state (`closing_state__v`). Then, configure an entry action using the _Send Training Evidence to eTMF_ action. During configuration, Vault populates the **Report for Site Evidence** and **Report for Trial Team** options with the standard recommended reports.
    * To opt out of sending a report, select **Not Applicable**.
    * To send a different report, see [additional details][2] about configuring a custom report.
5. Optional: Configure a user action using the _Send Training Evidence to eTMF_ action. The state(s) you select can be different from those configured in Step 4, as a user action is primarily recommended for sending reports ad-hoc, for reasons unrelated to the _Study_'s lifecycle state.
6. Review your Vault's security configuration and ensure users are assigned the appropriate [permissions][3].
7. Navigate to **Admin > Connections > Study Training to Clinical Operations Connection > Integrations > Study Training Materials Integration**. Under **Integration Points - Outbound**, update the **Study Training Materials Outbound Integration Point** _Status_ to "Active".
8. Optional (eTMF): Review your Vault's document type configuration. By default, this feature uses specific [eTMF document types][1] to store Study Training report CrossLinks. To store the reports elsewhere:
    * Update the connection's `document_type__sys` Reference Lookup to use the new document type(s), according to its Target Key.
    * Ensure the document type is properly assigned a corresponding lifecycle, and that the lifecycle has a state mapped to its _Steady State_ type.
9. In eTMF: Navigate to **Admin > Connections > Study Training to Clinical Operations Connection > Integrations > Study Training Materials Integration**. Under **Integration Points - Inbound**, update the **Study Training Materials Inbound Integration Point** _Status_ to "Active".
10. In eTMF: Navigate to **Admin > Configuration > Objects**. Within the **User Exception Message** object, create an action using the standard _Retry Study Training Transfer_ action. This allows Vault to retry any failed document transfers.


### About Custom Reports  {#about-custom-reports}

By default, this feature uses the Veeva-provided _Matrix Assignments: Site Evidence of Training_ and _Matrix Assignments_: _Trial Team Evidence of Training_ multi-pass reports. Though we **highly** recommend using these read-only reports, a Vault Admin can configure custom reports for the same purposes.

When configuring any custom reports and their related lifecycle entry actions or user actions, consider the following additional configuration parameters:

* To take full advantage of this feature, there should be two reports for capturing both site and trial team evidence of training.
* Custom reports must be created using the _Matrix Training Assignments_ report type.
* When configuring the _Study_ object lifecycle to _Send Training Evidence to eTMF_ via user and/or entry action (Step 4), ensure you select the correct custom report within the **Report for Site Evidence** and **Report for Trial Team** options.


## Limitations

The below limitations apply to this feature:

* This feature requires that any Vault-generated documents remain in their Steady state. It is important that these documents are not obsoleted or retired in the Study Training Vault.
* As of 25R1, this feature does not support _Training Assignments_ created via Direct Assignment or Self-Enrollment, as indicated by the assignment's _Creation Source_ field. This capability will be supported in a future release. In the meantime, organizations who would like to store these types of training records can create a report and manually file it in the eTMF Vault.


## Related Permissions  {#related-permissions}

To use this feature, users must be assigned a [permission set](/en/lr/23647/#how_to_edit_permission_sets) with the below permissions.

| Permission Label | Permission | Controls |
|---|---|
| Objects: Study: Object Action Permissions: Send Training Evidence to eTMF | View | Ability to view the user action on _Study_ records. |
| Objects: Study: Object Action Permissions: Send Training Evidence to eTMF | Execute | Ability to execute the user action on _Study_ records. |

[1]: #default-document-types
[2]: #about-custom-reports
[3]: #related-permissions