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SDV Configuration

# Sdv
Last updated: 04/14/2026

Configure Source Data Verification (SDV) settings including query and CRF verification rules.

Overview​

The SDV (Source Data Verification) app verifies clinical trial data against source documents. Configure it from Home → select your study → SDV.

note

SDV configuration requires the study to be in Design status. If the study is in Available or Frozen status, settings are read-only.

Access path​

  1. Open Home > My Page.

Open study from My Page

  1. Click Go to Study Home for your study.

Study home before opening SDV settings

  1. Open SDV from Installed Apps, then choose Setting.

SDV configuration screen

Configuration Options​

SettingOptionsDescription
Allow SDV when Queries is openYes / NoWhen set to Yes, users can perform SDV on data even when there are open queries on the subject or CRF. Default: No
Allow SDV a subject when CRF is not VerifiedYes / NoWhen set to Yes, users can mark a subject as SDV-complete even if not all CRFs have been verified. Default: No

Saving Changes​

Click Save settings to apply your configuration. Click Discard changes to revert unsaved edits.

Configure SDV for specific CRF items​

Use this setup when SDV should only apply to selected fields (for example: Condition, ICD-10 Code) instead of the entire CRF.

Step 1: Open CRF properties in event builder​

  1. Open Home → My Page.
  2. Click Go to Study Home for your study.
  3. Open Build → Events from the study navigation.
  4. Select the target event, then click Edit.
  5. Scroll to the target CRF and open its properties panel.

Specific-item step 1 - CRF2 properties

Step 2: Set Source Data Verification = Specific Items​

In the target CRF, set Source Data Verification to Specific Items.

Specific-item step 2 - select Specific Items

Step 3: Open Configure items for SDV​

Click Configure items for SDV.

Specific-item step 3 - open Configure items for SDV

Step 4: Select required fields​

Choose the exact fields to be verified (example: Condition, ICD-10 Code), then click Save Changes.

Specific-item step 4 - select Condition and ICD-10

Step 5: Submit event definition​

Review Confirm & Submit Definition CRFs, then submit.

Specific-item step 6 - confirm submit

Specific-item step 7 - submit action

After configuration is submitted, perform the actual verification workflow in Events.

  1. Confirm SDV settings match your study SOP before data-entry starts.
  2. Re-check settings after protocol updates that affect CRFs or verification strategy.
  3. If expected SDV workload is missing, confirm settings here first, then review Events.
SDVSource Data VerificationConfiguration
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