5 Ways eSource and EDC Integration Reduces Site Burden

In a 2022 site survey published by the Society for Clinical Research Sites, 98% of sites said they manually re-enter data into EDC systems, and nearly 70% of them said more than half of their EDC data is re-entered from existing EHR data (SCRS). The same article notes an average of 96,980 queries per Phase III study, many of them caused by transcription.

For a site, that means the same blood pressure, lab value or concomitant medication is written down at least twice: once in the source and again in the eCRF. Each copy is a chance for error, a query to answer and a data point for the CRA to verify. Integrating eSource with EDC removes the second entry.

What changes when the second entry goes away

1. Each data point is entered once

The biggest saving is the simplest one. When the site records a visit in eSource and the integrated fields flow to EDC, coordinators no longer re-type them. An Applied Clinical Trials report on an EHR-to-EDC project put the share of trial data duplicated between research systems and hospital records at over 70%, with around 20% of study costs going on duplicating and verifying data (Applied Clinical Trials).

2. Fewer transcription queries

Queries about a mistyped date or a unit mismatch take site time to investigate and answer. When the eCRF value comes straight from the source, those queries disappear, and the queries that remain are about clinical content.

3. Less time with the CRA on SDV

Source data verification checks that the eCRF matches the source. For fields that flow directly from eSource, there is no transcription step to verify, which shortens monitoring visits and frees the coordinator during them.

4. The visit follows the protocol

An eSource visit template built from the schedule of assessments prompts the coordinator for every required procedure at each visit. That reduces missed assessments, which are a common source of protocol deviations.

5. Data reaches the sponsor sooner

Data that would otherwise wait for staff time to be entered is available in EDC as soon as the visit is documented. Sponsors and data managers see issues earlier, and sites spend less time on catch-up entry before monitoring visits and data cuts.

What regulators expect

FDA's guidance on electronic source data in clinical investigations accepts direct entry of data into eCRFs and electronic transmission from source systems, provided the data originator is identified, an audit trail is kept and investigators can review their data. ICH E6(R3) applies the same principles of data integrity and traceability to computerised systems (ICH E6(R3), EMA Step 5). Integration does not remove the need for a clear definition of what the source is for each data point.

Site readiness checklist

• Define the source for each data point in a source data agreement or plan
• Confirm which eCRF fields are integrated and which are still entered manually
• Check that eSource templates match the current protocol version
• Make sure the audit trail shows who recorded each value and when
• Confirm the PI can review and sign data in the eSource system
• Agree the SDV approach for integrated fields with the sponsor or CRO
• Train coordinators on the eSource workflow before first patient

What this means by role

• CRCs: less re-typing, fewer transcription queries, and less catch-up entry before monitoring visits.
• Principal investigators: data is reviewed and signed in one place, with a clear audit trail.
• CRAs: time on site shifts from field-by-field comparison to reviewing the quality of the data and the conduct of the study.
• Clinical data managers: fewer transcription queries and faster data availability.
• Clinical operations managers and directors: shorter data entry lag and a more attractive study for busy sites.
• Quality and compliance directors: a single record of each data point, with its originator and audit trail.

How Cloudbyz approaches this

Cloudbyz builds eSource and EDC natively on Salesforce, on the same platform as its CTMS and eTMF. According to Cloudbyz product materials, Cloudbyz eSource supports visit management, eConsent, eCRFs, demographics, medical history and vital signs, AE and protocol deviation capture, lab reports, device integrations, query management and SDV and data review, along with export of data to EDC and portals for sponsors and CROs. Because both sit on one platform, data recorded once at the site can be shared with the study database rather than transcribed. How many fields flow automatically depends on how each study's eSource templates and EDC forms are configured.

See eSource and EDC together

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