What is eConsent in clinical trials?

eConsent uses electronic systems to support presentation of study information and documentation of informed consent. It may include electronic signatures and version tracking, but the staff-led discussion and participant’s voluntary decision remain central. The IRB-approved process determines how it may be used.

How does re-consent tracking work?

Staff associate the new consent version with the study and review participants who have older versions or pending assignments. The worklist supports follow-up and recording the new signed version. Your site determines the affected participants and timing under the IRB’s directions and protocol.

Does a signature mean consent is adequate?

No. The site must assess the whole process, including understandable information, opportunity for questions and the participant’s decision. A signed electronic record documents part of that process. It does not replace staff judgment about comprehension, voluntariness or applicable requirements.

Can we use electronic consent remotely?

Only where the IRB, protocol and applicable rules permit the proposed method. Review identity confirmation, participant access, signed copies and the opportunity to speak with staff. Ask to review the actual workflow for your study rather than assuming any electronic signature permits remote use.

When does study data entry unlock?

The sample illustrates completing consent work before study source entry. The re-consent guard checks pending required assignments on covered study-linked inserts, not every form, update or procedure. It does not establish initial informed consent by itself. Staff still confirm initial consent, signed evidence and current-version requirements.

What should we bring to the demo?

Bring a de-identified consent-version history and the IRB’s electronic consent requirements, not an actual signed participant document. Walk through an amendment, a pending assignment and a recorded signature. Check how your site would provide copies and preserve records under its procedures.

eConsent for clinical trials at independent research sites.

Connect consent versions, participant assignments and re-consent follow-up without replacing the staff-led conversation.

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Kyros Trials / Sample workspace

CARD-204 / Consent tracking

01ICF version changes
02Re-consent assigned
03Consent recorded

Active ICF: Version 2
204-0012: Completion recorded by staff
Site action: Check signed evidence
Study-linked source: Consent gate cleared

Sample gate only; staff check current requirements

Sample record. Not real participant data.

What breaks today

Informed consent is a process, not a signature button. The participant must receive understandable information, have the opportunity to ask questions and make a voluntary decision. Electronic records can help the site show which document version was used and which participants need follow-up after an amendment. Kyros Trials connects versions, assignments and signed records so staff can review consent status in the participant context. The IRB-approved approach, protocol and applicable consent requirements determine whether a particular electronic or remote process is appropriate for your study.

01I know they signed, but I need to check which version.
A signed document without a clear version creates extra reconciliation when a monitor asks about approval dates. The participant record should identify the document used, while staff verify that the version and process were appropriate at the time consent was obtained.
02The amendment changed the ICF. Who needs another conversation?
A new document can create participant-level work, not just a binder update. Staff need to review older signed versions and pending assignments. The IRB and protocol determine who needs re-consent and when; software should help track that work rather than make the clinical determination.
03The visit is ready, but consent evidence is missing.
A pending required re-consent assignment needs a clear staff action before covered study-linked source inserts. The record must distinguish administrative preparation from consent-dependent procedures. FDA and OHRP’s 2016 electronic consent Q&A describes considerations for the consent process; a workflow status alone is not evidence of understanding.

Clear measuring tubes on a laboratory bench — Illustrative workspace. Photo by CHUTTERSNAP on Unsplash.

Consent versions

Know which version each participant signed.

An amendment can change who needs re-consent. Connect the approved document, participant assignment and signed version instead of reconciling separate logs.

CARD-204 / Consent documents

Sample workflow

Document: Informed consent form
Version: Version 2
Site check: Confirm IRB approval before use

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.

Study consent documents: Associate informed-consent documents with the study.
Version identifiers: Keep the specific consent version identifiable.
Approval information: Retain the approval context for staff to review.
Participant assignments: Connect required consent work to participant records.
Signed-version status: See the version recorded for a participant.
Re-consent visibility: Review pending assignments after a version change.
Completion records: Record re-consent completion through the staff workflow.
Consent history: Review participant assignments and recorded completion history.
Staff follow-up: Use participant consent status to plan the next conversation.
Re-consent gate: Study-linked source inserts check pending required re-consent assignments.

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 50.27	Retains version assignments and staff-recorded consent completion.	Use the required documentation approach and provide a signed copy where required.
FDA/OHRP eIC Q&A, 2016	Supports electronic version, assignment and consent-tracking workflows.	Assess identity, comprehension, access, copies and the suitability of the consent process.
IRB approval of the version	Keeps document version and approval information available to staff.	Confirm approval, effective use dates and any required re-consent before use.

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

How it connects

The econsent with version and re-consent tracking workflow feeds the next site record while preserving the distinction between captured information, staff review and an authorized action.

01
ICF version
02
Re-consent task
03
Consent recorded
04
Source entry

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
Find the signed version	Search scanned packets and a separate consent log.	Review the participant’s recorded consent version.
Introduce an amendment	Copy a new document into a folder.	Review version-linked assignments and pending follow-up.
Track re-consent	Color-code rows in a manual participant tracker.	Consent work remains visible in participant context.
Retain evidence	Scan signatures separately from version metadata.	Keep signed version and signature history connected.
Check source readiness	A coordinator remembers to check the packet.	Pending required re-consent is checked on study-linked source inserts.

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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