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 configured, 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:
- Navigate to the Study SDR Plan section on a Study.
- Enter a Name.
- Enter a Target SDR Rate (%) value.
- Select a Risk Level from the drop-down menu.
- Optional: Enter a value for the Initial Review Count.
- 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 configured the Copy Study SDR Plan 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
Vault generates an SDR Item record once the system selects a Subject for SDR and updates the SDR Requiredness field for related Subject Visits to Required. The SDR Item record tracks the completion of the SDR activity. Clinical Research Associates (CRAs) are responsible for tracking the completion of these items during their monitoring activities. Vault tracks the completion of these activities with the SDR Complete? and SDR Complete Date fields.
Seeding SDR into Monitoring Events
CRAs can track the completion of SDR Items within the context of monitoring events. If configured, Vault triggest the Proactively Seed Monitored Enrollment action Vault triggers the Proactively Seed Monitored Enrollment action when a Monitoring Event 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.