SDV Corrects 1.1% of Trial Data. Here's What Changes When eSource Feeds EDC

A TransCelerate analysis of 1,168 Phase I to IV trials found that source data verification corrected only 1.1% of the total eCRF data set. Across all methods, just 3.7% of eCRF data was corrected after initial entry by site staff, and in nine sample studies only 2.4% of queries on critical data were driven by SDV (Sheetz et al., Therapeutic Innovation & Regulatory Science).

SDV exists because data is copied: from the source document into the eCRF. Comparing the two field by field catches transcription errors, and that is most of what it catches. When eSource feeds EDC directly, the copy step disappears for integrated fields, and so does the reason to check it. Monitoring time can move to the checks that do protect participants and data.

Where monitoring time goes, before and after

1. The transcription check goes away for integrated fields

If a vital sign or lab value moves from the source to the eCRF without being typed again, there is no transcription to verify. Monitors can confirm the integration is working and move on.

2. Source data review gets the time it needs

Source data review looks at the quality of the source itself: protocol compliance, whether procedures were done at the right visit, whether the documentation is complete. TransCelerate's work found SDR and central monitoring to be of higher value than SDV (Clinical Leader).

3. Eligibility, consent and safety stay on-site priorities

Integration removes copying, not judgement. Eligibility decisions, informed consent and the identification of adverse events still need a monitor's review, and these are where findings that matter to participants are made.

4. Central monitoring works on current data

Central statistical and risk-based review is only as good as the data it sees. When data reaches EDC soon after the visit, central monitors can spot site patterns while there is still time to act.

5. Monitoring becomes risk-proportionate in practice

ICH E6(R3) asks for oversight proportionate to risk and focused on critical-to-quality factors (ICH E6(R3), EMA Step 5). Removing transcription checks frees the time that makes a risk-based monitoring plan realistic.

Monitoring checklist for integrated studies

• List which eCRF fields come directly from eSource and which are still entered manually
• Limit SDV to non-integrated critical fields
• Define what on-site SDR covers for each visit type
• Keep eligibility, consent and AE review as on-site priorities
• Set central monitoring indicators that use near real-time data
• Record the approach in the monitoring plan

What this means by role

• CRAs: less field-by-field comparison, more time on protocol compliance, consent and safety.
• Clinical operations managers and directors: a monitoring plan that matches E6(R3), with visits that focus on risk.
• Clinical data managers: fewer transcription queries, and central review on current data.
• QA and compliance directors: the monitoring approach is documented and justified by where errors actually arise.
• CRCs and PIs: shorter monitoring visits, with questions about the conduct of the study rather than typos.

How Cloudbyz approaches this

Cloudbyz builds eSource and EDC natively on Salesforce.  Cloudbyz eSource covers visit management, eCRFs, vital signs, AE capture, lab reports, device integrations, query management, SDV and data review, and export of data to EDC. Cloudbyz CTMS manages monitoring visits and reports on the same platform.

The CRA Monitoring Copilot, built on Agentforce, points monitors to the forms and subjects to prioritise for verification and assembles the pre-visit package, so on-site time goes where it matters. It drafts only; every judgement stays with the CRA. Which fields can skip SDV depends on how a study's eSource and EDC are configured and on the sponsor's monitoring plan.

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