Enable the Safety-EDC Vault Connection

Learn how to configure your Safety Vault to enable the Safety-EDC Vault Connection.

About the Feature

With the 24R1 release, organizations with Safety and CDMS EDC Vaults can use a standard Vault to Vault connection. The Safety-EDC Vault 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 CDMS Vaults to your Safety Vault for case processing. Site Investigators can enter and update Adverse Event forms in your CDMS Vault, then transfer the SAE data, along with the applicable subject and Case information, to your Safety Vault.

Updates

We have added the following updates to this feature:

  • New Fields & Error Messages: With the 24R3 release, the Safety-EDC Vault Connection expands the data transferred between EDC Vaults and Safety Vaults, including the Site Narrative for each event.
  • Send SAE Reporter Details to Safety: With the 24R3 release, the Safety-EDC Vault connection supports sending SAE reporter details from EDC to Vault Safety.
  • Support Case & Subject Deletion Scenarios from EDC: With the 24R2 release, we added the EDC Reason field to the Inbox Item object to track case and subject information changes in EDC and the ability to map custom fields between CDMS EDC and Safety Vaults.

Prerequisites

Before starting the enablement instructions on this page, ensure you have established a Vault to Vault connection between your Safety and CDMS Vaults.

Once you have completed the enablement instructions on this page, see the following resources:

Configure Merge to In-Flight Case

For more information, see Enable Merge to In-Flight Case.

(Optional) Add CDMS Subject Information Objects to Business Admin

You can optionally make the CDMS subject information objects 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.

Repeat these steps for all CDMS subject information objects:

  • CDMS Subject Adverse Event
  • CDMS Subject Case Product
  • CDMS Subject Case Product Dosage
  • CDMS Subject Cause of Death
  • CDMS Subject Drug History
  • CDMS Subject Event Product Assessment
  • CDMS Subject Height History
  • CDMS Subject Last Menstruations
  • CDMS Subject Links
  • CDMS Subject Medical History
  • CDMS Subject Pregnancy Information
  • CDMS Subject Test Results
  • CDMS Subject Weight History

Configure Object Layouts

You must configure object layouts 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.

(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.

(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 to the Case Validity and Source section.
  4. Optional: Add the CDMS Subject Information field to the Case Validity and Source section.
  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.

(24R2) Mapping Custom Fields

You can map custom fields from your CDMS 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 Configuring the Safety-EDC Vault Connection.

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 user action 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 enabled Case Access Group Security:

  1. Add the Subject Information Review picklist to the Details section of the User Access Group Assignment object layout.
  2. Create or update a Case Assignment Rule 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 CDMS 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 view subject information and run the Add Relevant Subject Information action on Cases with SAE data transferred from the Safety-EDC Vault Connection, you must add the following permissions to each relevant permission set:

  • Read permission on all CDMS subject information objects:
    • CDMS Subject Adverse Event
    • CDMS Subject Case Product
    • CDMS Subject Case Product Dosage
    • CDMS Subject Cause of Death
    • CDMS Subject Drug History
    • CDMS Subject Event Product Assessment
    • CDMS Subject Height History
    • CDMS Subject Information
    • CDMS Subject Last Menstruations
    • CDMS Subject Links
    • CDMS Subject Medical History
    • CDMS Subject Pregnancy Information
    • CDMS Subject Information
    • CDMS Subject Test Results
    • CDMS Subject Weight History
  • Execute permission on the Add Relevant Subject Information action.

(24R3) Configure Send SAE Reporter Details to Safety

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