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Ideas
Direct record-to-database data capture: no manual transcription, no full source verification

Direct record-to-database data capture: no manual transcription, no full source verification

Trial staff still retype data from the hospital record into the trial database, and monitors then check every entry by hand. Piping data directly and checking by risk would cut cost and errors.

Overview Connected3

Overview

Structured EHR data (labs, vitals, medications, imaging reports, deaths) flow into the trial database via FHIR-based eSource interfaces with audit trails; source data verification is replaced by risk-based and statistical monitoring, as permitted by ICH E6(R3). Requires standardised oncology data elements (mCODE) and vendor cooperation.

Hypothesis

eSource trials will reduce data management and monitoring cost per patient by at least 30 percent and reduce transcription errors, with equivalent or better data quality on audit.

Rationale

Manual transcription is the largest source of trial data error and monitoring is the largest single cost line; both are artefacts of paper-era processes. Other regulated industries moved to direct data capture decades ago.

Proposed test

Run one cooperative-group trial with eSource at half its sites and conventional capture at the rest; compare cost, query rates and audit findings.

Maturity

early clinical

Who acts

engineering

Cost to try

Medium ($1M to $50M)

Years to first evidence

3

Bottlenecks it attacks

Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
Data silos · Records, scans, genomes and outcomes sit in separate systems that cannot talk. Every patient's experience is lost to the next.

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technologies

AI trial matching & clinical decision support

bottlenecks

Data silos Trial design, endpoints and cost

ProvenanceLast edited 2026-09-08 · Jude Gomila · Ideas wave · diff · file

Sources & links

CDISC standards
mCODE

Data

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Technologies

AI trial matching & clinical decision support

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