Curebase Targeted Source Data Verification (SDV)
Verify what matters. Reduce monitoring burden. Keep every decision inspection-ready.
Curebase Targeted SDV lets study teams focus source data verification on the participants, visits, forms, and fields that carry the most risk, instead of verifying every data point on every subject. It is built into the Curebase eClinical platform, so your monitoring strategy travels with the study from startup through database lock.
See it in Action
Watch this demo to see how it works
Keep readingWhy Targeted SDV exists
Source data verification is one of the most expensive and time-consuming activities in a clinical trial, and industry analysis has long shown that it can absorb a large share of total monitoring budgets. Yet not every data point carries the same clinical value or risk. Verifying 100% of data treats a routine field the same as a primary endpoint.
Regulators now encourage a smarter path. FDA guidance and ICH E6(R3) both direct sponsors toward risk-based, quality-by-design strategies that concentrate oversight on the data and processes most critical to participant safety and data quality.
Today, targeted SDV plans often live in cumbersome spreadsheets that are difficult to build, error-prone to maintain, and painful to roll out to monitoring staff. Every change means re-communicating rules and hoping each monitor applies them consistently. Curebase removes that burden entirely. Verification rules are automated, and site monitors can see requirements in reporting and forms. When the strategy changes, the updated requirements flow through automatically, so monitors always work from the current plan without a manual rollout.
The old way
Traditional 100% SDV
The Curebase way
Curebase Targeted SDV
Every field on every subject is verified
Verification is focused by risk, sampling, and data criticality
High CRA workload and cost
Effort concentrated on high-value data
Slower path to database lock
Faster, leaner monitoring cycles
Same treatment for routine and critical data
Critical data always protected
A simple interface for building your SDV strategy
Curebase gives study teams a single place to design a complete SDV strategy, without spreadsheets, manual tracking, or guesswork. You layer targeted rules on top of your study and Curebase applies them automatically as data is captured.
| What you configure | What it does |
|---|---|
| Rules by visit and form | Target verification to specific visits and forms so monitoring intensity follows your data considerations |
| Site risk levels | Apply different coverage to sites based on their risk profile |
| Initial participant block | Fully verify the first participants at each site to establish a clean baseline before sampling begins |
| Critical data protection | Keep fields marked as Critical Data always verified, regardless of broader sampling |
| Coverage percentages | Set form and field level verification coverage, tuned per site risk level |
Dial in verification to the exact rules you need
Verification should match risk, not a blanket percentage. Curebase lets you define precise sampling ratios across participants, visits, and forms, so the right proportion of data is verified automatically, every time. For example:
- Verify 1 out of every 6 screening visits for low risk sites.
- Require 100% verification of all adverse event forms, so safety-critical data is never sampled out.
- Sample a defined share of routine forms while keeping efficacy and endpoint data fully covered.
And when you need to go deeper, Curebase gives you field-level granularity: configure SDV rules for individual fields, so a single high-risk data point on an otherwise routine form can still be flagged for verification.
Version and deploy without disruption
As your study evolves, your SDV considerations will likely change. Curebase lets you version and deploy different SDV configurations without redeploying your study build, so monitoring can adapt to new risks while your study stays live.
How the strategy comes to life
Once a strategy is defined, Curebase does the heavy lifting. As data is captured, the platform evaluates site risk, sampling rules, and critical-data requirements to determine exactly what needs verification, then flags those records for review. CRAs verify only the fields in scope, and Curebase records who verified each record and when, so every verification decision is captured and inspection-ready.
Key benefits
| Benefit | Why it matters |
|---|---|
| Lower monitoring burden | Focus CRA effort on high-value data instead of blanket verification |
| Faster database lock | Prioritize critical data and endpoints to shorten monitoring cycles |
| Protected critical data | Critical-to-quality fields stay verified even under reduced sampling |
| Consistent execution | Automated, rule-driven selection replaces manual judgment |
| Inspection-ready | Versioned strategies make it clear what was verified and why |
