eSource means the first recording of a value is electronic, so there is no paper worksheet to transcribe later. Capture lets site staff enter measurements straight into the eCRF and participants answer straight into an ePRO task, with source data verification set per field and an audit trail on every change. Try it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Data point | Paper worksheet | Direct entry in Capture | |
|---|---|---|---|
| Blood pressure at the visit | Transcribed later | Entered at the visit | |
| Participant diary | Booklet, copied | Answered on the phone | |
| Visit-measured weight | Transcribed later | Entered at the visit | |
| Hospital lab report | Original stays outside | Original stays outside |
What eSource means in practice for a site
Definition
FDA’s September 2013 guidance on electronic source data in clinical investigations describes electronic source data as data initially recorded in electronic form. Source data itself is the information in original records and certified copies of those records. The guidance is non-binding and was written to encourage capturing source electronically, and secondary summaries add that eSource describes where data originated, not the system that holds it. The consequence is simple. A blood pressure typed into an eCRF while the participant sits in front of the coordinator is electronic source. The same value copied from a handwritten sheet an hour later is a transcription, and the sheet is the source.
The other half of the record-keeping debate is trust. Regulators expect electronic records to be attributable, legible, contemporaneous, original and accurate, extended in the ALCOA-plus checklist covered on our ALCOA-plus checklist page. A field-level audit trail, role-based access and electronic signatures speak to attribution and change history. For Capture’s controls in more detail, see the 21 CFR Part 11-aligned EDC page. Compliance is a shared responsibility between the software and the site’s and sponsor’s own validated use of it.
This page is about the site’s day-to-day work. It overlaps with, but is narrower than, sites going paperless, which also covers consent, diaries and regulatory binders. Here the question is only: which values can you record once, in the system, and how is that verified?
Be precise when you talk to your sponsor. Capture sits at the lighter end of the eSource range: site staff enter observations into eCRF forms and participants enter their own reports into ePRO tasks. It does not claim an electronic medical record integration, and it is not an EHR. If the hospital record is source, the eCRF is a transcription target for those fields, and the monitoring plan should say so.
Source mapping
The sponsor’s or site’s source data agreement is the controlling document. This table shows a typical split for a small study, as demo content.
| Data point | Original record | Where it is entered in Capture | Verification |
|---|---|---|---|
| Vital signs at the visit | Direct eCRF entry at the visit | Vital signs form with edit checks and calculated MAP | Per-field SDV on endpoint values |
| Participant symptom diary | The participant’s own ePRO entry | Phone questionnaire with a completion window and reminders | Compliance view; no site transcription |
| Physical exam findings | Direct eCRF entry | Physical exam form | Per-field SDV where required |
| Hospital lab results | Lab report held outside the EDC | Lab results form with reference ranges and a source note | Monitor compares value with the report |
| Medical history | Medical record or participant interview | Medical history form | Depends on the source agreement |
| Informed consent | Signed electronic record | eConsent with countersignature and PDF export | Signature record and audit trail |
| Adverse events | Investigator assessment, medical record | Adverse event form | Review by monitor and medical reviewer |
Illustrative mapping. Your protocol, monitoring plan and source data agreement decide what is source.
Build a vital signs form in the free sandbox, enter a value outside your range and see the auto-query, the audit trail and the SDV flag. No credit card, no time limit.
Verification
Verification still matters when entry is direct. In Capture, source data verification can be set per field, so the monitor’s time goes where the data matter and a verified field is visibly distinct from one that is not yet checked.
Systolic blood pressure
SYSBPSDV complete
Diastolic blood pressure
DIABPSDV complete
Heart rate
HRSDV not required by plan
Weight
WEIGHTSDV pending
Trust in the record
Direct entry makes mistakes visible in a different way. A coordinator who mistypes a weight can correct it, and the correction shows the old value, the new value, who changed it, when and the stated reason. The trail is written by database triggers, is append-only and cannot be changed through the interface, and clinical data is soft-deleted only. That is the property a monitor reads when judging whether an electronic original can be trusted. See audit trail software for clinical trials.
Roles keep the right people on the right forms: site coordinators see participant names for their site, researchers see coded IDs, and the separation is enforced at the database layer. Who is allowed to enter and sign for what is a site delegation question; the delegation log template helps document it, and the monitoring visit report template is useful whichever way the visit is run.
Edit checks help at the point of entry. When a site types a value that breaks a range or custom rule, Capture raises an auto-query straight away, so many corrections happen in the room instead of weeks later. For form design details, see how to design an eCRF.
What changes
Getting started
A realistic order of work for a site, an SMO or an investigator-initiated study.
For every data point, record where the original lives. Agree it with the sponsor and the monitor.
Upload the protocol and let the AI study builder draft the visits and forms for review, or convert existing sheets; see paper CRF to eCRF conversion.
Mark the fields that need verification and add ranges so errors show up at entry.
Run a practice visit with a coordinator and a monitor, including a correction and a query. Free, with every feature.
Start the paid live phase when real participants enrol, and keep a short list of data points whose original stays outside the system.
Honest limits
Capture does not read from an electronic medical record, does not import hospital lab or imaging systems automatically and is not a certified-copy repository. If your protocol requires the hospital record to be source for some fields, those fields are transcribed and verified in the usual way, and the site keeps the original. Whether a given entry is source is a decision for the sponsor, the investigator and the regulator, not for the software. Nothing here is regulatory advice.
It is also not the right tool for a site that needs a full regulatory binder system or a clinical trial management system; see clinical trial software for study sites and EDC for independent trial sites for what Capture does cover. Capture is suitable for Phase 1, 2 and 3.
Electronic source data is data initially recorded in electronic form, such as a measurement typed into an eCRF at the visit or a participant’s answer to an electronic diary. If the first recording was on paper, the paper is the source.
No. Capture is direct data entry into eCRF forms and ePRO tasks. It does not claim an EMR integration.
For values that you record directly in the eCRF or that participants enter in ePRO, yes, if your sponsor and protocol agree. Other originals, such as hospital lab reports, stay outside the system.
Yes. Capture lets you set SDV per field so verification focuses on what matters, and records the state with the audit trail.
The new value is entered with a reason. The audit trail keeps the old value, new value, user, timestamp and reason, and cannot be modified through the interface.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
Sites going paperless
Consent, diaries and eRegulatory alongside eSource.
Source data verification (glossary)
What SDV is and why it is changing.
Clinical trial software for study sites
What sites get from Capture.
Vital signs eCRF template
A direct-entry form to copy and adapt.
Capture eCRF builder
Forms, edit checks and calculated fields.
Free sandbox, every feature. No credit card, pay only when you go live.