# Creating & Managing Issues

Vault provides the ability to capture and manage different types of _Issues_ across a study country or study site including _Observations_, _Protocol Deviations_, [_Mitigation Actions_](/en/lr/62007/#mitigation-actions), and any other custom object types relevant to your business model. You can track _Issues_ for follow up, promote or demote them to different object types, and seed them directly into _Monitoring Events_.

This functionality is available in all CTMS Vaults but requires some [configuration by your Admin](/en/lr/68403/) for full utilization.

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      <p><strong>Note</strong>: Depending on the configuration of your Vault, the <em>Issue</em> object may be labeled <em>Protocol Deviation</em>.</p>
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## Creating Issues {#create-issues}

You can create _Issues_ from the related object sections of _Study Site_ and _Study Country_ records, from the **Actions** menu of the _Study Quality_ widget on the [CRA Homepage](/en/lr/39905/#study-quality), from **Admin > Business Admin**, or from a custom tab.

Depending on the configuration of your Vault, you may also be able to create _Issue_ records directly in a _Monitoring Event_ when you are answering questions that require you to log follow up items.

## Promoting & Demoting Issues {#promote-demote}

When configured, you can promote and demote individual _Issue_ records to different _Issue_ types. For example, you log an _Observation_ type of _Issue_, but after review, you realize that it is actually a protocol deviation and requires escalation. In this case, you can change the object type to _Protocol Deviation_.

To change the object type of an _Issue_ record:

  1. Navigate to an _Issue_ record.
  2. From the **Actions** menu, select the appropriate option to promote or demote the _Issue_ to a different issue type.
  3. In the _Change Issue Type_ dialog, click **Continue** to confirm the change. Note that Vault will not store the values of any fields that do not exist on the new _Issue_ type.

## Copying Issues to Multiple Subjects

In configured Vaults, you can create identical _Issue_ records for multiple _Subjects_ at the same _Site_ by selecting the **Bulk Copy Issue** action. Admin must configure the **Bulk Copy Issue** user action on the _Issue_ object. 

To bulk copy _Issue_ records:
1. Navigate to an _Issue_ record.
2. Select the **Bulk Copy Issue** user action. This opens a dialog.
3. In the dialog, select the checkbox for all **Subjects** you want to create an _Issue_ record for. The dialog only displays active _Subjects_ at the _Site_ listed on the _Issue_ record. 
4. Click **Continue**.

Once you click _Continue_, Vault creates a new _Issue_ record for each selected _Subject_ identical to the original _Issue_ record. Vault copies the original field values to the new _Issue_ records and updates the _Subject_ and _Subject Group_ fields with the corresponding data for the new _Subject._ Vault also populates the _Copied From_ field on new _Issue_ records with the value of the original _Issue_ record.

## Related Permissions {#related-permissions}

You can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner security profile.

If your Vault uses custom security profiles, your profile must grant the following [permissions](/en/lr/22824/):

| Type | Pernission Label | Controls |
|:----|:----|:----|
| Security Profile | Objects: Issue `(pdv__ctms)`: Create, Edit | Ability to create, edit, promote, and demote **Issue** records. Note that you must have **Create** and **Edit** permission on all object types for the **Issue** object. |
| Security Profile | Objects: Monitored Issue: Read | Ability to view the **Monitored Issues** that Vault seeds into a **Monitoring Event** record. |
| Security Profile | Objects: Monitored Issue: Create, Edit | Ability to create and edit **Monitored Issue** records. |
| Security Profile | Objects: Question: Read, Create, Edit | Ability to view, create, and edit **Issues** and follow up items on a **Monitoring Event Question**. |