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SDV Role-Based SOP

# Sdv
Last updated: 04/14/2026

Purpose

Purpose​

This SOP defines role ownership and handoff for Source Data Verification (SDV) operations, from CRF-level verification through subject-level sign-off.

Use this page for operational alignment between CRA/Monitor teams, Data Managers, and study administrators.

Scope​

  • Module: SDV
  • Main activities: CRF-level SDV, Item-level SDV, Subject-level SDV
  • Main roles in this SOP:
    • CRA / Site Monitor — performs day-to-day SDV
    • Lead Monitor / Data Manager — oversees SDV completion and quality
    • Study Administrator — configures SDV scope and rules

Account Mapping by Role​

SOP RoleTypical Permissions
CRA / Site Monitorsdv.events.view, sdv.verify.crf, sdv.verify.subject
Lead Monitor / Data ManagerAll CRA permissions + sdv.unverify, sdv.bulk
Study Administratorsdv.config — setup and scope changes

Role Matrix by Activity​

ActivityCRA / Site MonitorLead Monitor / Data ManagerStudy Admin
View SDV Events (View by CRF)YesYesYes
View SDV Events (View by Subject)YesYesYes
Verify individual CRF itemsYesYes—
Verify entire CRF (Verify Form)YesYes—
Verify Subject—Yes (controlled)—
Un-Verify CRF—Yes—
Un-Verify Subject—Yes—
Bulk Verify / Un-Verify—Yes—
Configure SDV scope & rules——Yes
Configure Item-Level SDV——Yes

Step-by-Step SOP​

Step 1 — CRF-Level Verification (CRA / Site Monitor)​

  1. Open SDV → Events → View by CRF
  2. Filter by SDV status Not done to focus on pending items
  3. Click the CRF Name / Version link to open the CRF in SDV context
  4. Compare each field value against the source document
  5. Click Unverified button for each field to mark as verified
  6. After all required fields are verified, click Verify Form
  7. Confirm the CRF shows SDV badge (green) and status changes to Verified

Expected output: CRF marked as Verified in View by CRF.

Step 2 — Item-Level SDV (CRA / Site Monitor)​

For CRFs configured with SDV Requirement = Partial Required:

  1. Open CRF from View by CRF — only SDV-required items show Unverified buttons
  2. Verify each required item individually against source
  3. CRF auto-promotes to Verified when all required items are done
  4. Cannot use Verify Form — each item must be individually verified

Expected output: All required items verified, CRF auto-promoted.

Step 3 — Subject-Level Verification (Lead Monitor / Data Manager)​

  1. Open SDV → Events → View by Subject
  2. Confirm all required CRFs are verified (check # of Verified CRF SDVs vs Total Available CRFs)
  3. Review SDV status column — subject must be eligible (Verify button visible)
  4. Click Verify and confirm in the dialog
  5. Subject SDV status updates to reflect completion

Prerequisites:

  • All required CRFs in at least one complete event must be verified
  • If Allow SDV a subject when CRF is not Verified = No, ALL CRFs across ALL events must be verified first

Expected output: Subject marked as SDV-complete.

Step 4 — Un-Verify (Lead Monitor / Data Manager only)​

Use when a verified CRF or subject needs re-verification:

  1. In View by CRF, click Un-Verify on a verified row
  2. Provide a reason in the note dialog
  3. The CRF returns to Not done status
  4. Re-perform verification as needed

Expected output: CRF available for re-verification with audit trail of un-verify action.

Step 5 — Bulk Operations (Lead Monitor / Data Manager only)​

For efficiency when handling large volumes:

  1. In View by CRF or View by Subject, select checkboxes for multiple rows
  2. Click Verify Selected or Unverify Selected
  3. Confirm in the dialog

Expected output: Multiple CRFs/subjects processed in one action.

SDV Completion Governance​

When to mark SDV complete​

CheckpointCriteria
CRF-LevelAll required items marked Verified, Verify Form clicked
Subject-LevelAll required CRFs across all events verified (or minimum one event, per config)
Study-LevelAll enrolled subjects with SDV-required data verified

Quality Checks​

  1. Random sample of verified CRFs reviewed by Lead Monitor
  2. SDV completion rates tracked against monitoring plan targets
  3. Un-verify actions reviewed for patterns (may indicate training needs)

Audit Requirements​

  • Every SDV action (verify, unverify, bulk) is recorded with user, timestamp, and scope
  • Status notes are required for un-verify actions
  • Audit trail accessible from Subject Casebook and SDV Events page
SDVSOPCRAData ManagerRole
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