# Enable the Safety-EDC Connection

With the 24R1 release, organizations with Safety and Clinical Data EDC Vaults can use a standard connection. The Safety-EDC Connection automatically transfers the creation, updates, and deletion of case and subject-related records. The connection exchanges data about serious adverse events (SAEs) discovered by study sites from EDC Vaults to your Safety Vault for case processing. Site Investigators can enter and update _Safety Case Initiation Event_ forms in your EDC Vault, then transfer the SAE data, along with the applicable subject and _Case_ information, to your Safety Vault.


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      <p><strong>Note</strong>: Vault does not support the <a href="/en/lr/01393/"><em>Promote to Multiple Cases</em></a> or <a href="/en/lr/740208/#initial"><em>New Case - Copy Patient Information</em></a> actions for <em>Inbox Items</em> generated by the Safety-EDC Connection.</p>
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### Updates

We have added the following updates to this feature:

* **Handling Product Indication**: With the 26R1 release, the connection transfers product indications for both study drugs and concomitant medications.
* **Linking Parent & Child Case Information**: With the 25R3 release, Vault [links _Cases_ for parent and child SAEs][7] in Safety Vaults based on transferred pregnancy data in Vaults with <a href="/en/lr/01321/">Pregnancy and Parent-Child Case Data Collection</a> and <a href="/en/lr/01328/">Pregnancy Case Intake</a> enabled.
* **Safety-EDC Connection: Improvements for Mapping, Merging & Error Handling**: With the 25R3 release, the Safety-EDC Connection transfers AESI and study drug details from EDC, which allows users to review this value and proceed according to your business processes. After <a class="external-link " href="https://cdmshelp.veeva.com/gr/study-designers/edc-safety-connection/#custom-safety-fields" target="_blank" rel="noopener">mapping<i class="fa fa-external-link" aria-hidden="true"></i></a> the fields in your EDC Vault, you must [add the field to the applicable object layouts][6].
* **New Fields & Error Messages**: With the 24R3 release, the Safety-EDC Connection expands the data transferred between EDC Vaults and Safety Vaults, including the [_Site Narrative_][4] for each event.
* **Send SAE Reporter Details to Safety**: With the 24R3 release, the Safety-EDC connection supports [sending SAE reporter details from EDC to Vault Safety][3].
* **Support Case & Subject Deletion Scenarios from EDC**: With the 24R2 release, we added the [_EDC Reason_ field][1] to the _Inbox Item_ object to track case and subject information changes in EDC and the ability to [map custom fields][2] between EDC and Safety Vaults.
* **Automated Classification of Inbox Item Significance**: With the 24R2 release, we added the ability to <a href="/en/lr/725776/">automatically calculate _Significance_ on _Inbox Items_</a> generated by the connection.

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      <p><strong>Note</strong>: To receive all available data mappings from EDC, ensure you have copied the latest standard layouts for all <a href="/en/lr/679350/#cdms-subject-records">EDC subject information objects</a>, activated them, and set them as the defaults.</p>
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## Prerequisites

Before starting the enablement instructions on this page, ensure you have <a href="/en/lr/53358/#how-to-establish-a-vault-to-vault-connection">established a connection</a> between your Safety and EDC Vaults.

Once you have completed the enablement instructions on this page, see the following resources:
* <a href="/en/lr/679352/">Configuring the Safety-EDC Connection</a> for information about Integration configuration and more.
* <a href="/en/lr/679350/">About the Safety-EDC Connection</a> on how this connection works.

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      <p><strong>Note</strong>: If your Vault was provisioned in 24R1 or later, some of this configuration may already exist. Customers with Vaults before 24R1 must complete all the configuration steps listed on this page.</p>
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## Configure Merge to In-Flight Case

For more information, see <a href="/en/lr/01339/">Enable Merge to In-Flight Case</a>.

## (Optional) Add Subject Information Objects to Business Admin {#subject-information}

You can optionally make the <a href="/en/lr/679350/#cdms-subject-records">subject information objects</a> accessible in _Business Admin_ to assist you with troubleshooting. To do this:

1. Go to **Admin > Configuration > Objects > [Object] > Details**.
2. Select **Edit**.
3. In the _Options_ section, select the **Display in Business Admin** checkbox.
4. Select **Save**.

## Configure Object Layouts

You must configure <a href="/en/lr/26387/">object layouts</a> to support this feature.

### Case Access Group Assignment

Complete the following steps to configure the _Case Access Group Assignment_ object layout:
1. Go to **Admin > Configuration > Objects > Case Access Group Assignment > Layouts**.
2. Select **Case Access Group Assignment Detail Layout**.
3. Add the **Subject Information Review** field to the _Details_ section.
4. Select **Save**.

### (25R3) CDMS Subject Adverse Event & Case Adverse Event {#edc-aesi}

Complete the following steps to configure the _CDMS Subject Adverse Event_ and _Case Adverse Event_ object layouts:

1. Go to **Admin > Configuration > Objects > [Object] > Layouts**.
2. Select the appropriate layout.
3. Add the **EDC AESI** field to the _Details_ section.
4. Select **Save**.

### <a id="site-narrative"></a>(24R3) Case

Complete the following steps to configure the _Case_ object layout:

1. Navigate to **Admin > Configuration > Objects > Case > Layouts.**
2. Select the appropriate layout.
3. In the _Details_ section, add the **Site Narrative** field.
4. Select **Save**.

### <a id="edc-reason"></a>(24R2) Inbox Item

Complete the following steps to configure the _Inbox Item_ object layout:
1. Go to **Admin > Configuration > Objects > Inbox Item > Layouts**.
2. Select the appropriate layout.
3. Add the **EDC Reason** field.
4. Optional: Add the **EDC Subject Information** field.
5. Select **Save**.

## Configure Object Fields

You must configure the _Pregnancy_ (`pregnancy_case__v`) field on the _CDMS Subject Information_ object:
1. Go to **Admin > Configuration > Objects > CDMS Subject Information > Fields > Pregnancy**.
2. If the **Show as checkbox** checkbox is selected:
    1. Select **Edit**.
    2. Clear the checkbox.
    3. Select **Save**.

### <a id="custom-fields"></a>(24R2) Mapping Custom Fields

You can map custom fields from your EDC to your Safety Vault so that the mapped fields automatically populate with the data received from the Safety-EDC Connection on the related subject information and case objects. For more information, see <a href="/en/lr/679352/">Configuring the Safety-EDC Connection</a>.

## Configure the Add Relevant Subject Information Action

You must configure the _Add Relevant Subject Information_ user action on the _Case_ object:
1. Go to **Admin > Configuration > Objects > Case > Actions**.
2. Select **Create**.
3. In the dialog, select **Add Relevant Subject Information**.
4. Select **Continue**.
5. Do one (1) of the following:
    * Select the **Available in All Lifecycle States** checkbox to apply atomic action security defaults for the applicable lifecycle states.
    * Add the action as a <a href="/en/lr/59885/#user-actions">user action</a> to the applicable states of the object's lifecycle.
6. Optional: To automatically generate _Assessments_ when users run the _Add Relevant Subject Information_ action:
    1. Go to  **Admin > Settings > Safety General Settings**.
    2. Select **Edit**.
    3. Select the **Generate Assessments for both Serious and Non-Serious Adverse Events** checkbox.
    4. Select **Save**.
    
## Configure Case Access Group Security

If you've previously <a href="/en/lr/01304/">enabled Case Access Group Security</a>:

1. Add the _Subject Information Review_ picklist to the _Details_ section of the _User Access Group Assignment_ <a href="/en/lr/26387/">object layout</a>.
2. Create or update a <a href="/en/lr/01182/#create-case-assignment-rules">_Case Assignment Rule_</a> to support the connection:
    1. Go to **Business Admin > Objects > Case Access Groups**.
    2. Select **Create** or open the appropriate record.
    3. In the _Case Assignment Rules_ section, select **Create**.
    4. For **Intake Method**, select **Safety-EDC Connection**.
    5. Add any other applicable details.
    6. Select **Save**.
3. Create or update a **Case Access Group Assignment** to support the connection:
    1. Go to **Business Admin > Objects > Case Access Group Assignments**.
    2. Select **Create** or open the appropriate record.
    3. Select **Edit**.
    4. For **Subject Information Review**, select **Subject Information Review**.
    5. Add the applicable details.
    6. Select **Save**.

## Configure User Permissions

For users to run the _Add Relevant Subject Information_ action on _Cases_ with SAE data transferred from the Safety-EDC Connection, you must add the following <a href="/en/lr/22824/">permissions</a> to each relevant permission set:

* _Read_ permission on all <a href="/en/lr/679350/#cdms-subject-records">EDC subject information objects</a>.
* _Create_ permission on the associated case objects to which each <a href="/en/lr/679350/#cdms-subject-records">EDC subject information object</a> maps.
* _Execute_ permission on the _Add Relevant Subject Information_ action.

## (25R3) Linking Parent & Child Case Information {#r25r3}

To support the transfer of pregnancy data and linking the applicable _Cases_ in your Safety Vault, we recommend completing the following:

* Configure a <a href="/en/lr/42778/#how-to-set-a-field-default">field default</a> for the _Related Case Identifier_ field on the _Case Relationship_ object to populate the _Worldwide UID_ value of the linked _Case_.
    * Enter the following value for the _Default Value_ field: `related_case__vr.case_number__vr.worldwide_uid__v`
* <a href="/en/lr/32857/#assign">Assign</a>  the _EDC Subject Information_ field to the _Parent Information_ type of _Case_ object and ensure it's added to the _Parent Information_ <a href="/en/lr/26387/">layout</a> for the _Case_ object.
* Copy the standard layout for the following objects, activate the copied layout and set it as the default, then delete any other existing custom layouts:
    * _CDMS Subject Information_
    * _CDMS Subject Adverse Event_

## (24R3) Configure Send SAE Reporter Details to Safety {#r24r3}

To support the transfer of SAE reporter details from EDC, add the following fields to your default _CDMS Subject Adverse Event_ object layout in the applicable reporter details section:

* _Reporter City_
* _Reporter Country_
* _Reporter Email_
* _Reporter First Name_
* _Reporter Last Name_
* _Reporter Postal Code_
* _Reporter Qualification_
* _Reporter State / Province_
* _Reporter Street_
* _Reporter Street 2_
* _Reporter Telephone_
* _Reporters Comments_

[1]: #edc-reason
[2]: #custom-fields
[3]: #r24r3
[4]: #site-narrative
[5]: #subject-information
[6]: #edc-aesi
[7]: #r25r3