An electronic health record (EHR) is the hospital’s or clinic’s record of a patient’s care. An electronic data capture (EDC) system is where a clinical trial’s protocol-defined data is entered, checked, queried and locked. The EHR is often where the original observation lives; the EDC is where the trial dataset gets built. Capture is an EDC. It does not replace an EHR and has no EHR integration.
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Visit happens
Clinician records care in the EHR
Source is identified
Protocol says which values come from where
Values entered in the EDC
Per visit, per protocol form
Edit checks and queries
Out-of-range or missing values questioned
Verification and lock
Source data verification, then database lock
The direct answer
Definitions
An EHR (sometimes EMR, electronic medical record) is the clinical record: histories, clinic notes, medication orders, laboratory and imaging results, discharge summaries. It is designed around the clinician’s workflow and the institution’s care and billing obligations. Its data model is shaped by that purpose, so the same vital sign can appear in a note, a flowsheet and a result field, in different formats and with different timing.
An EDC system is the opposite shape. It starts from the protocol and the case report form and asks for exactly the data points the protocol defines, at the visits the protocol defines, in the format the analysis needs. It validates what is entered with edit checks, raises queries when something does not look right, records an audit trail of every change with the reason, and ends in a database lock before analysis. If you want the broader definition, see our what is EDC guide.
An EHR has no concept of a protocol visit window, an eligibility criterion that must be met before randomisation, a blinded role or a query to the investigator from a monitor. It records care as it was delivered, including everything unrelated to the study. Pulling a research dataset straight out of it means reconstructing the protocol logic afterwards, and the audit trail of the study record would then be the hospital’s audit trail, not one built for the trial.
An EDC holds only what the protocol asks for. It is not a place to document the rest of a patient’s care, and a trial participant’s clinical safety still depends on the care record. Capture does not replace an EHR and does not claim any integration with one.
Side by side
| EHR | EDC | |
|---|---|---|
| Purpose | Document and run patient care | Capture and clean protocol-defined trial data |
| Owner | The hospital or clinic | The study, accessible to sponsor, CRO, monitors and site staff by role |
| Data model | Whatever clinicians documented, in varied formats | Fixed forms by visit, with defined fields, units and codes |
| Validation | Limited to clinical and billing needs | Edit checks, required fields, calculated fields |
| Queries | None in the research sense | Monitor and data manager queries with a resolution trail |
| Audit trail | Institutional access and change history | Field-level history with who, when, old and new value and reason |
| Blinding and roles | Care roles | Study roles, including blinded users |
| Output | Charts, reports, billing | Analysis-ready datasets and a locked database |
| Regulatory frame | Healthcare record rules and privacy law | GCP and, for FDA-regulated studies, 21 CFR Part 11 for the electronic records |
FDA’s 2018 EHR guidance states that FDA does not intend to assess EHR systems for Part 11 compliance, but trial data must still be verifiable for quality and integrity.
Source data
GCP defines source data as the original records and certified copies where the observations are first recorded. When a participant’s blood pressure is measured at a clinic and documented in the hospital record, that entry is source. The value then travels to the case report form. Three patterns are common.
A coordinator reads the EHR and types the required values into the EDC. This is the dominant pattern in most investigator-led and early-phase studies. Its weakness is transcription error, which is why monitors verify a sample of entries against source. Our page on source data verification covers that process, and the SDV glossary entry defines the term.
Some sponsors and health systems connect the two electronically so that selected values flow from the EHR into the eCRF. FDA’s 2018 guidance describes interoperable or integrated EHR and EDC systems and how electronic source principles apply to them. This needs a technical integration at the institution, standards-based data and agreement on responsibilities. It is not a feature of every EDC.
For data collected only for the study, such as a research-specific questionnaire or a protocol assessment not done as part of care, the first recording can be made directly in the EDC or ePRO, which is the eSource approach. See our EDC vs eSource comparison and eSource for clinical sites.
Decision
You need an EDC. The EHR remains source for care-related values, but it is not the trial database.
An EHR-derived dataset may be enough. If you need structured forms, queries and an audit trail for the study, add an EDC.
Use an EDC or ePRO and record them directly there. They do not exist in the EHR.
You need an EHR integration plan at institutional level. Check whether your EDC supports it before you commit.
Keep the EHR for care and use an EDC per study for the research record. See clinical trial software for hospital research offices.
That is feasibility or recruitment work, usually a cohort tool or EHR query, not an EDC job.
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In Capture
Capture is the trial side. Site staff enter or abstract values from source into protocol forms, edit checks raise queries when a value breaks a rule, and source data verification can be set per field so monitors know which entries must be checked against source. Every change is in a field-level audit trail with a reason. Capture does not connect to an EHR, so values from the care record are entered by site staff rather than pulled automatically.
Changed by Data manager · reason: critical safety value added
Honest fit
Capture is a good fit as the EDC. Phase 1 to 3 trials and investigator-led studies both work.
Capture is a good fit, with entry by site staff. It also works alongside the care record, which stays the source for care data.
Not available. Capture has no EHR integration, so plan on manual entry or abstraction.
Not what Capture is. It does not replace an EHR.
An EHR is the electronic record of a patient’s care, owned by the hospital or clinic. An EDC is a system for entering, validating and managing the data a clinical trial protocol requires. The EHR is often the source of some values; the EDC holds the trial record.
Generally no. An EHR does not enforce a protocol, raise monitor queries, support blinded roles or lock a database for analysis. Large pragmatic trials may draw heavily on EHR data, but they still need a research data layer with its own controls.
Often yes, for values documented as part of routine care. The protocol and the site’s source documentation should say which values are source in the EHR and which are recorded first in the EDC or an ePRO.
No. Capture does not claim any EHR integration. Site staff enter or abstract values from the care record into protocol forms, and source data verification can be set per field.
FDA published final guidance on the use of electronic health record data in clinical investigations in July 2018. It covers interoperable EHR and EDC systems and how electronic source principles apply, and says FDA does not intend to assess EHR systems for Part 11 compliance. Check the current text.
Yes in practice. EMR (electronic medical record) is often used for a record inside one practice and EHR for a record shared across providers, but the contrast with an EDC is the same.
Often yes, for any data collected for the study, such as consent, eligibility confirmation, safety events and study-specific assessments. A pure registry may be different. Decide based on what the protocol requires you to prove.
Yes. Capture’s free sandbox includes every feature with sample data, no credit card, and you pay only when you go live with real participants.
Keep exploring
EDC vs eSource
Where the original observation is recorded.
eSource for clinical sites
Direct entry at the visit, no paper.
Source data verification
How entries are checked against source.
What is EDC?
The system in plain terms.
Best EDC for hospitals and health systems
Research data alongside a hospital record.
Capture EDC
Protocol forms, edit checks, queries and audit trail.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.