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 page layouts.
- 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 Initial Review Count (
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 Study and Study Site lifecycles.
- Configure the Proactively Seed Monitoring Enrollment user or entry action.
Configuring the Study Lifecycle 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:
- Navigate to Configuration > Object Lifecycles > Study Lifecycle.
- Select the Active lifecycle state.
- Select Edit for Entry Criteria.
- Select Create Rule.
- Add the Always > Validate that > Study SDR Plans > At least one record equals > Approved entry criteria rule.
- 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
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:
- Navigate to Configuration > Object Lifecycles > Study Site Lifecycle.
- Select the Initiating lifecycle state.
- Select Edit for Entry Action.
- Select Create Entry Action.
- Add the Always > Copy Study SDR Plan entry action.
- Click Save.
To configure the Entry Criteria for the Study Site lifecycle:
- Navigate to Configuration > Object Lifecycles > Study Site Lifecycle.
- Select the Active lifecycle state.
- Select Edit for Entry Criteria.
- Select Create Rule.
- Add the Always > Validate that > State of Related Record > SDR Plans > At least one record equals > Approved entry criteria rule.
- Click Save.
Configuring Seeding of 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 Monitoring Event 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
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 permissions:
| 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. |