# Configuring Source Data Review (SDR)

The Source Data Review (SDR) feature allows you to utilize a more risk-based approach when reviewing clinical trial source data. With SDR, Vault selects a percentage of subject data for review and validation for each _Study Site_ based on the risk level. An Admin must configure the SDR feature before you can use it in Vault.  

## Configuration Overview
* Configure necessary _SDR_-related <a href="/en/gr/26387/">page layouts</a>.
    * Add the **Study SDR Plan** object section to the **Study** page layout.
    * Optional: Add the **Study SDR Plan** object section to the **Study Country** page layout.
    * Add the **SDR Plan** object section to the **Study Site** page layout. 
    * Add the **SDR Item** object section to the **Subject** page layout.
    * Add the **SDR Item** object section to the **Subject Visit** page layout. 
    * Optional: Activate the **Risk Level** field on the **Study Site** object and add the field to the page layout.
    * Activate the **Selected for SDR** and **SDR Requiredness** fields on the **Subject** object and add the fields to the page layout.
    * Activate the **SDR Requiredness** field on the **Subject Visit** object and add the field to the page layout.
    * Configure the <a href="/en/gr/832623/#configuring-initial-review-count-field">**Initial Review Count**</a> (`initial_review_count__v`) field on the **Study SDR Plan** and **SDR Plan** objects and page layouts.  
* Configure entry criteria and user actions for the <a href="/en/gr/832623/#configuring-lifecycles-for-sdr">_Study_ and _Study Site_ lifecycles</a>.
* Configure the <a href="/en/gr/832623/#seeding-sdr-items-for-monitoring-events">_Proactively Seed Monitoring Enrollment_ </a> user or entry action. 

##  Configuring the Study Lifecycle for SDR {#configuring-lifecycles-for-sdr}

We recommend that you configure entry criteria for the _Study_ lifecycle when using the _Study SDR Plan_ object. 

To configure the validation entry criteria for the _Study_ lifecycle:
1. Navigate to **Configuration > Object Lifecycles > Study Lifecycle**.
2. Select the **Active** lifecycle state.
3. Select **Edit** for **Entry Criteria**. 
4. Select **Create Rule**. 
5. Add the **Always > Validate that > Study SDR Plans > At least one record equals > Approved** entry criteria rule.
6. Click **Save**. 

If you use the _Study SDR Plan_ on the _Study Country_ level, duplicate the _Study_ lifecycle configuration for the _Study Country_ lifecycle.

## Configuring the Study Site Lifecycle for SDR {#study-site-lifecycle-sdr}
When using the _SDR Plan_ object, we recommend configuring entry actions and entry criteria for the _Study Site_ lifecycle. 

To configure the _Entry Action_ for the _Study Site_ lifecycle:
1. Navigate to **Configuration > Object Lifecycles > Study Site Lifecycle**.
2. Select the **Initiating** lifecycle state.
3. Select **Edit** for **Entry Action**. 
4. Select **Create Entry Action**. 
5. Add the **Always > Copy Study SDR Plan** entry action. 
6. Click **Save**.

To configure the _Entry Criteria_ for the _Study Site_ lifecycle:
1. Navigate to **Configuration > Object Lifecycles > Study Site Lifecycle**.
2. Select the **Active** lifecycle state.
3. Select **Edit** for **Entry Criteria**. 
4. Select **Create Rule**. 
5. Add the **Always > Validate that > State of Related Record > SDR Plans > At least one record equals > Approved** entry criteria rule.
6. Click **Save**. 

## Configuring Seeding of SDR Items for Monitoring Events {#seeding-sdr-items-for-monitoring-events}

You can configure Vault to seed _Monitored Subjects_, _Monitored Subject Visits_, and _Monitored SDR Items_ using the _Proactively Seed Monitoring Enrollment_ user or entry actions.

To seed _Monitored SDR Items_, add the **Proactively Seed Monitored Enrollment** entry action when a **Monitoring Event** begins to the **In Progress** state on the <a href="/en/gr/42835/">_Monitoring Event_</a> lifecycle. Add the **Proactively Seed Monitored Enrollment** to necessary _Monitoring Event_ lifecycle states to re-seed data for visits that occur over multiple days. 

To view _Monitored SDR Items_ that are seeded into _Monitoring Events_, also add the **Monitored SDR Item** related object section to Monitoring Event object page layouts that apply.


## Configuring the Initial Review Count Field {#configuring-initial-review-count-field}

You can use the _Initial Review Count_ (`initial_review_count__v`) field on _Study SDR Plans_ and _SDR Plans_ to establish a fixed number of _Subjects_ for SDR selection and review before Vault begins the broader selection based on the _Target SDR Rate (%)._ 

You do not have to use the _Initial Review Count_ field on _Study SDR Plans_ and _SDR Plans_. However, you enter a number in the _Initial Review Count_ field when creating _Study SDR Plans_ and _SDR Plans_. Enter **zero (0)** for the **Initial Review Count** field if you choose not to use it. 
If you choose not to use the _Initial Review Count_ field, you can configure it to default to zero (0) and remove it from necessary page layouts.

## Related Permissions

You can complete all steps in this article with the System Admin or Vault Owner profile. If your Vault uses custom security profiles, your profile must have the following <a href="/en/gr/22824/">permissions</a>:

| Field | Description  | Controls  |
| ----- | ------------ | --------- |
| Security Profile | Object: Study SDR Plan: Read, Create, Edit, Delete | The ability to view, create, edit, and delete Study _SDR Plan_ records. |
| Security Profile | Object: SDR Plan: Read, Create, Edit, Delete | The ability to view, create, edit, and delete _SDR Plan_ records. |
| Security Profile | Object: SDR Item: Visit SDR Item: Read, Create, Edit, Delete | The ability to view, create, edit, and delete _Visit SDR Item_ records for _SDR Items_. |
| Security Profile | Object: Monitored SDR Item: Visit SDR Item: Read, Create, Edit, Delete | The ability to view, create, edit, and delete _Visit SDR Item_ records for _Monitored SDR Items_. |
| Security Profile | Admin: Object Lifecycles: Read, Edit | Ability to configure the entry actions, entry criteria, and user actions to the necessary lifecycles. |