# Tracking Source Data Review (SDR)

Vault allows you to take a more risk-based approach to tracking reviews of clinical trial source data contained in site source documents with Source Data Review (SDR). With SDR, Vault utilizes _Study Site_ risk levels to select a percentage of subject data for review and validation.

## Creating Study SDR Plans

You can create _Study SDR Plans_ on _Study_ records or _Study Country_ records. Once configured <a href="/en/gr/832623/">configured</a>, approved _Study SDR Plans_ copy to _SDR Plans_ on _Study Sites_. _Study SDR Plans_ match to _Risk Level_ fields on _Study Sites_ to create the _SDR Plans_.

Each _Study SDR Plan_ contains the following fields:

| Field | Description  |
| ------| ------------ |
| Name | The label associated with the _Study SDR Plan_ record.|
| Label | The _Study_ record that the _Study SDR Plan_ applies to. Vault can apply the approved _Study SDR Plan_ to all _Study Sites_ under the _Study_ record. |
| Study Country | An optional field defining the _Study Country_ record that the _Study SDR Plan_ applies to. Vault can apply the approved _Study SDR Plan_ to all _Study Sites_ under the _Study Country_ record. |
| Target SDR Rate (%) | A number field that defines the desired percentage of _Subjects_ Vault selects for SDR for a _Study Site_. Vault only accepts the following simple percentage values for this field: 10, 20, 25, 30, 33, 40, 50, 60, 66, 70, 75, 80, 90, or 100. |
| Risk Level | An optional picklist field with _High_, _Medium_, and _Low_ values. Vault uses this field to match the _Study SDR Plan_ with the _Study Site_ records with the same defined _Risk Level_ field value. |
| Initial Review Count | A number field that defines the fixed number of _Subjects_ Vault selects for review before beginning the broader, rate-based selection defined by the _Target SDR Rate (%)_ field. |

To create a _Study SDR Plan_: 
1. Navigate to the **Study SDR Plan** section on a **Study**.
2. Enter a **Name**.
3. Enter a **Target SDR Rate (%)** value. 
4. Select a **Risk Level** from the drop-down menu.
5. Optional: Enter a value for the **Initial Review Count**.
6. Select **Save**. 

## Creating SDR Plans

You can use approved _Study SDR Plans_ to create _SDR Plans_ for a _Study Site_ via the _Copy Study SDR Plan_ entry action.

If you approve a _Study SDR Plan_ for both a _Study_ and _Study Country_, Vault uses the _Study Country's_ _Study SDR Plan_. If a _Study SDR Plan_ is only present for the Study, Vault uses the _Study's_ _Study SDR Plan_. The _Risk Level_ field on the _Study SDR Plan_ and _Study Site_ determines the correct _Study SDR Plan_ to reference when creating the _SDR Plan_.

If your Admin has <a href="/en/gr/832623/#study-site-lifecycle-sdr">configured the _Copy Study SDR Plan_ </a> entry action on a state in the _Study Site Lifecycle_, Vault creates an _SDR Plan_ based on the approved _Study SDR Plan_ when a _Study Site_ moves to a specified lifecycle state. Enter a _Start Date_ on an _SDR Plan_ to approve and activate it.

### Re-evaluating SDR Plans

The _Re-evaluate SDR Plan_ user action allows you to recalculate the SDR selections based on the Study Site's approved _SDR Plans_. Perform the **Re-evaluate SDR Plan** user action on _Study Sites_ to have Vault re-evaluate SDR Plans and generate SDR Items.

## SDR Selection

Vault selects _Subjects_ for SDR as you create _Subject_ data for a _Study Site_. Vault uses the _Target SDR Rate (%)_ value in the approved _SDR Plan_ to determine the number of _Subjects_ to select. Vault never selects _Screen Failed Subjects_ for SDR. Vault only considers _Subjects_ with populated _Enrolled Date_ fields. 

As you enroll _Subjects_, Vault selects _Subjects_ based on the _Target SDR Rate (%)_ value. When Vault selects a _Subject_, Vault sets the _Selected for SDR_ field to _Yes_ and _SDR Requiredness_ to _Required_. Vault also sets the _SDR Requiredness_ field to _Required_ and creates _SDR Items_ for each _Subject Visit_ for _Subjects_ it selects.

## Generating SDR Items

_SDR Item_ records track the completion of the SDR activities for _Subject Visits_. Clinical Research Associates (CRAs) are responsible for tracking the completion of these items during their monitoring activities. Vault generates _SDR Item_ records for _Subject Visits_ once the system sets the _SDR Requiredness_ field to _Required and_ selects a _Subject_ record for SDR. If users manually update the _SDR Requiredness_ field from _Not Required_ to _Required_ for a _Subject Visit_ record, Vault then generates the corresponding _SDR Item_ record.

Vault tracks the completion of the SDR activities with the _SDR Complete?_ and _SDR Complete Date_ fields on the _SDR Item_ record. When a user updates the _SDR Complete?_ field to _Yes_, Vault automatically updates the _SDR Complete?_ field on the corresponding _Subject Visit_ record to _Yes_, synchronizing completion data between records.

## Seeding SDR Items into Monitoring Events

CRAs can track the completion of _SDR Items_ within the context of monitoring events. If configured, Vault triggers the <a href="/en/gr/832623/#seeding-sdr-items-for-monitoring-events">_Proactively Seed Monitored Enrollment_ action</a> Vault triggers the _Proactively Seed Monitored Enrollment_ action when a <a href="/en/gr/42835/">_Monitoring Event_</a> enters the appropriate lifecycle state. This action seeds _SDR Items_ as _Monitored SDR Items_ based on the following criteria:
* The previous and current _Monitoring Events_ do not have an _Actual Visit End Date_ and the _SDR Complete Date_ occurs before today.
* The current _Monitoring Event_ does not have an _Actual Visit End Date_ but the previous _Monitoring Event_ has an _Actual Visit End Date_ and the _SDR Complete Date_ occurs between the previous _Monitoring Event_ _Actual Visit End Date_ and today.
* The current _Monitoring Event_ has an _Actual Visit End Date_ and the previous _Monitoring Event_ does not have an _Actual Visit End Date_ and the _SDR Complete Date_ occurs before the current _Monitored Event's_ _Actual Visit End Date_.
* The previous and current _Monitoring Events_ have _Actual Visit End Dates_ and the _SDR Complete Date_ occurs after the previous _Monitoring Event's Actual Visit End Date_ and on or before the current _Monitoring Event's Actual Visit End Date_.
* The _SDR Requiredness_ field has the _Required_ value on the _SDR Item_, but the _SDR Complete Date_ field is blank.