What is eSource in clinical trials?

eSource is original source data captured electronically, rather than first recorded on paper and later transcribed. Its value depends on attribution, traceability and an appropriate source-data process. FDA’s 2013 guidance explains considerations for electronic source data in clinical investigations.

Is eSource the same as an eCRF?

No. Source is the original record supporting the observation; an eCRF is a structured case report form used to report trial data. A site must establish the source designation and reporting arrangement with the sponsor. A shared form does not remove those responsibilities.

How does a field query work?

A reviewer raises a question against the relevant field. The coordinator responds with the necessary clarification, and the query retains its relationship to the source record. Your monitor and site procedures determine whether the answer resolves the issue and whether a correction is needed.

What happens after the investigator signs?

The signature is linked to the record and the signer re-authenticates. Subsequent regulated changes require the controlled change or unlock workflow with a reason. Ask to inspect the signature meaning, record history and permissions instead of relying on a signature-shaped mark alone.

Does using eSource establish Part 11 compliance?

No software establishes that outcome by itself. Kyros Trials supports audit trails, electronic signatures with re-authentication and access controls. Compliance depends on how each site validates and uses the system. Your site must assess its intended use, procedures, training and retention obligations.

Can we use the exports in the sponsor’s system?

Kyros Trials provides export to CDISC ODM 1.3.2 and SDTM-aligned CSV. The sponsor’s required structure, terminology and transfer specification still need review. An available export format is not a promise that a particular sponsor will accept it without mapping or reconciliation.

eSource and eCRF for independent research sites.

Capture visit data, answer field queries and retain investigator sign-off alongside the source record.

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Kyros Trials / Sample workspace

204-0012 / Week 4 / Vitals

01Query opened
02Coordinator answers
03PI signs

Blood pressure: 118 / 76 mmHg
Field query: Resolved for review
Source clarification: Seated after rest
Investigator review: Signed / re-authentication

Signature linked to the reviewed source

Sample record. Not real participant data.

What breaks today

A value needs context: which participant, which visit, which procedure and who recorded it. Electronic source is not just a paper worksheet displayed on a tablet. It must support a reviewable record when a coordinator corrects a value, a monitor asks a question or an investigator signs. Kyros Trials connects visit forms, field queries, verification and signatures. Bring one real procedure specification to a demo and inspect the sample record from initial entry through a reasoned correction, rather than evaluating only an empty form.

01I wrote it once, then typed it into another form.
Transcribing a worksheet creates another handoff to reconcile. The site still needs to distinguish its original source from the sponsor’s reporting requirements. Capture the visit record electronically where appropriate, then confirm what the sponsor needs to receive and how exports will be reviewed.
02The monitor asked about one field, but the answer is in email.
A query loses context when its question, answer and source value live in different places. Keeping the query with the field gives the next reviewer a clearer path through the issue. Staff still need to provide a clinically appropriate, documented response.
03I can see the corrected value, but not why it changed.
A correction should retain the original value, responsible user, time and reason. The original entry does not stop mattering when a form is updated. FDA’s 2013 electronic source guidance emphasizes source identification and traceability; use that guidance to frame your site’s review.

Notebook and pens on a workspace — Illustrative workspace. Photo by Kelly Sikkema on Unsplash.

Source and review

Follow a value, not a paper trail.

Source capture, monitor review and investigator sign-off are distinct steps. A record should show which step it has reached and who is responsible next.

204-0012 / Week 4 / Vitals

Sample workflow

Assessment: Blood pressure
Sample value: 118 / 76 mmHg
Record: Entered by the coordinator

Illustrative workflow. Not live records or customer results.

What’s included

These are core site workflows, available with Advanced off. Access still follows your staff roles and study permissions. Optional AI depends on the plan and service configuration.

Visit-linked forms: Open electronic forms in the study and visit context.
Procedure fields: Capture the values required for the configured procedure.
Required-field checks: Prompt staff for required information before submission.
Edit checks: Review configured range and format issues during capture.
Field-level queries: Keep a reviewer’s question tied to the source field.
Query responses: Retain staff answers within the review workflow.
Verification status: Distinguish entered source from completed review.
Investigator signatures: Require the authorized signer to re-authenticate.
Reasoned corrections: Retain before/after values and the stated change reason.
Data exports: Review CDISC ODM 1.3.2 and SDTM-aligned CSV exports.

Controls and site responsibilities

Use this mapping to structure your review, not as a regulatory determination. Regulations and guidance describe expectations; your intended use, procedures, training and evidence determine how the workflow supports your study.

Regulation, software support and site responsibility
Regulation or requirement	What Kyros Trials does	What your site still owns
21 CFR 11.10(e)	Retains time-stamped change history with user, values and reason.	Review audit trails and establish retention and review procedures.
21 CFR 11.50 and 11.70	Links signature identity, time and meaning to the record.	Define signing responsibilities and verify signature manifestations in use.
21 CFR 11.200	Uses signer re-authentication and controlled account access.	Establish identity, credential management and electronic-signature procedures.
FDA eSource guidance, 2013	Connects electronic visit capture and field review to records.	Identify authorized source originators and reconcile sponsor data requirements.
ICH E6(R3) data integrity	Preserves traceable changes and review context.	Assess data criticality, system suitability and documented site procedures.

Compliance depends on how each site validates and uses the system.

How it connects

The esource and ecrf for clinical research sites workflow feeds the next site record while preserving the distinction between captured information, staff review and an authorized action.

01
Visit
02
Source
03
Signature
04
Billable item

A connected record is not an automatic approval. Staff check the underlying evidence, confirm permissions and decide when the next step is appropriate. The sample demonstrates a handoff; it does not access clinical records or imply a measured customer result.

Before and after, at the site

Paper or spreadsheets compared with Kyros Trials workflows
Site task	Paper or spreadsheets	Kyros Trials
Capture a measurement	Worksheet followed by another manual entry.	Electronic capture within the configured visit form.
Answer a query	Email thread separate from the source field.	Question and response retained with review context.
Correct a value	Strike-through and initials need later reconciliation.	Reasoned change with before/after audit values.
Obtain PI review	A paper stack waiting for wet signatures.	Authorized signature with re-authentication and record linkage.
Prepare sponsor data	Manual assembly from unrelated files.	Structured exports for site and sponsor review.

Workflow comparison, not a claim of time saved or improved clinical outcomes. Review the steps against your own protocol and operating procedures.

Bring your data from CRIO, RealTime-CTMS or spreadsheets

Start with a de-identified export and agree on the field mapping before moving records. Staff review identifiers, dates, statuses and the destination structure. Keep the original records available under your retention policy; a CSV import does not reconstruct another system’s audit trail. Document and historical-record migration require a separate review of available exports and file structure.

Review switching Open the related site resource

Published pricing, before the demo

Included in every plan. Published price: $599 per site per month.

That is the Site plan price. Starter is $299 per month with its study limits; Network is $499 per location per month for two or more locations. Core modules are included across plans. AI drafting and prescreen chat are Site and Network options and require configuration. Review current terms and limits before selecting a plan.

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Questions before you choose

Answers to the questions research sites ask most.

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Related site workflows and resources

See your own protocol in Kyros Trials.

Walk through your visit schedule, source records and sponsor billing with our team.

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