...

Identification of clinical trial participants

The consent must be signed by the person who passed screening, and the person who signed must be the one who comes to the visit. NeuroVision recognises the passport, checks that it is genuine and valid, while Liveness and a match of the face against the photo in the document confirm that its holder is in front of the camera — at enrolment and at every visit.

A trial participant checked before signing the information sheet: passport, Liveness and site registry
3 methods sign the electronic patient information sheet: QES, NQES or simple e-signature via ESIA
from 29 ₽ a document, selfie and Liveness in one session
5 ₽ passport validity
195+ countries and territories — documents of foreign participants
Passport SNILS and compulsory health insurance policy Child's document Liveness at the visit Site registry NeuroSign

A cloud in Russia or your perimeter · Russian software registry, entry no. 19972 · Federal Law 152‑FZ

The trial participant and the law: Federal Law 61‑FZ, the information sheet and insurance

A clinical trial of a medicinal product runs under a permit and a protocol, and every participant has rights that the law lists explicitly. A summary of the rules as of 27.10.2026, not a legal opinion.

  • Consent: Art. 43 and Art. 4(49) of Federal Law 61‑FZ

    Consent is confirmed by a signature on the information sheet.

    Electronic sheet

    Voluntary

    • Participation in the trial is voluntary and a participant may withdraw at any stage

    What participants are told in advance

    • About the drug, the risks, the aims and duration, insurance and confidentiality — in writing, including in electronic form

    Paper or electronic

    • The sheet is signed on paper or electronically: with a QES, an NQES or a simple signature via ESIA
  • Insurance: Art. 44 of Federal Law 61‑FZ

    Each participant is assigned an individual identification code.

    Checks at each stage

    Who provides the insurance

    • The organisation that obtained the trial permit insures the participant's life and health at its own expense

    Participant code

    • The policyholder assigns the participant an individual identification code and reports the enrolled participants to the insurer

    Payout by code

    • To receive an insurance payout, the participant or the beneficiary gives the insurer this code
  • Children and data: Art. 43 of 61‑FZ, Art. 13 of 323‑FZ, Art. 10 of 152‑FZ

    Information about a participant and their health is medical confidentiality.

    Cloud or on-premises

    Children

    • A child is enrolled with the consent of a parent or adoptive parent, signed on the information sheet

    Medical confidentiality

    • The fact of seeking medical care, the state of health and the diagnosis are medical confidentiality

    Special category

    • Health data is a special category of personal data: written consent, or processing by a medical professional bound to keep it confidential

Wrong participant — spoiled data: what an identity error costs the site and the sponsor

Checks at screening and at every visit

Passport, Liveness and a face-to-document-photo match — before the sheet is signed, and again when the participant comes for the drug

  • 01

    One person passed screening, another came to the visit

    A healthy volunteer is examined and then sends an acquaintance to take the drug. Safety data is collected from someone other than the person selected against the protocol criteria.

  • 02

    A volunteer in two trials at once

    A person who recently took another drug hides it to get a new reward. The washout period set in the protocol is broken, and there is nothing to compare the adverse reactions with.

  • 03

    The signature on the sheet does not match the person

    The information sheet is signed, but who signed it was checked only by word of mouth. During sponsor monitoring or an inspection, such consent puts the participant's enrolment in question.

  • 04

    The insurance code goes to someone who did not take part

    The participant code is tied to the person the site enrolled. If enrolment was on someone else's passport, then in an insured event the identity of the injured person and the code will not match.

  • Art. 43(3) consent is confirmed by a signature on the sheet
  • Art. 44(8) each participant has their own code
  • from 29 ₽ a document and Liveness in one session

Screening, enrolment, visits, payouts: who checks the participant at each protocol stage

Six stages of participation — from the form on the recruitment site to the payment of compensation. Each row shows who carries it out.

  • The candidate fills in a form on the recruitment site or calls the site Done by the site
  • The passport is recognised from a photo, the date of birth is checked against the protocol age criteria, and the passport is checked for validity NeuroVision
  • The passport number is matched against the site's participant registry — a repeat application is visible immediately NeuroVision

  • Before taking part, the candidate is told about the drug, the risks, insurance and confidentiality; consent is given by signing the information sheet Law
  • Before signing — a selfie, Liveness and a match of the face against the passport photo: the sheet is signed by the holder of the document NeuroVision
  • The sheet is signed on paper or electronically — QES, NQES or simple e-signature via ESIA — in the site's system Done by the site

  • The decision to enrol against the protocol criteria is made by the investigator Done by the site
  • SNILS and the health insurance policy are recognised for the participant record, and the full name and SNILS are matched against the database NeuroVision
  • The participant is assigned an individual code for insurance and sponsor documents LawDone by the site

  • At every visit the participant shows the passport again and passes Liveness, and the face is matched against the photo in that passport NeuroVision
  • A remote visit — the same check in the Web SDK or the app, with no trip to the front desk NeuroVision
  • Medical procedures and records — in the site's system and the trial documents Done by the site

  • A child is enrolled with the consent of a parent or adoptive parent on the information sheet Law
  • Birth certificate and the parent's passport — in one session, and the parent's full name is matched NeuroVision
  • Documents of a guardian or legal representative — from a template, as an additional document NeuroVision

  • The volunteer agreement, acts and compensation claims are signed in NeuroSign with an audit trail NeuroVision
  • For payouts — the taxpayer ID (INN) from the passport for 5 ₽, bank details without retyping NeuroVision
  • The participant receives the insurance payout from the insurer by their own code Law
  • Law — what the law requires
  • Done by the site — the site performs the step: the form, information, the sheet in the site's system, the enrolment decision, procedures
  • NeuroVision — the step is closed by a NeuroVision check: documents, matching, Liveness, NeuroSign
  • A summary of the rules as of 27.10.2026; the exact text is in ConsultantPlus. How the electronic sheet is signed — in the consent block.

Research sites, CROs, sponsors: who needs participant checks

The check is the same, only the entry point changes: the recruitment form, screening, a visit or a payout.

  • Research sites and clinical facilities

    • Passport and Liveness before the sheet is signed
    • Repeat check at the visit
    • Data stays in your perimeter. Passport and selfie
  • Phase I sites with healthy volunteers

    • A repeat application — by document number
    • Someone else's passport at screening
    • The agreement and compensation in NeuroSign. NeuroSign
  • Contract research organisations (CROs)

    • One check scenario across all sites
    • Session log for monitoring
    • API into your system
  • Sponsors and pharmaceutical companies

    • A requirement for sites: verify the participant's identity
    • The sponsor sees a code, not a passport
    • Cloud in Russia or the site's own perimeter
  • Recruitment and e-consent services

    • Candidate check before handover to the site
    • Web SDK and mobile SDKs
    • Documents of foreign nationals from 195+ countries and territories. API
  • A trial coordinator checks the participant's documents on a tablet

Documents and identity of a trial participant: what NeuroVision checks

One session — one person: their documents, a child's documents, database checks and a face match. Whether to enrol a participant is decided by the investigator.

  • Passport, SNILS and health insurance policy — into the participant record

    The candidate photographs the documents on the recruitment site or at the site's desk, and the fields arrive ready in under a second. Russian passports and documents of foreign nationals from 195+ countries and territories.

    • Passport
    • Social insurance no.
    • OMS
    Learn more
  • Site participant registry

    The document number is matched against participants of your past and current trials. A repeat application or participation after a short break is visible before screening — without face recognition.

    • Document number
    Learn more
  • Selfie, Liveness and matching with the passport

    A live person is in front of the camera, their face matches the photo in the passport they are showing now, and the age from the face matches the date of birth. Liveness — 99.9 %, ISO 30107‑3 / iBeta.

    • Liveness
    • 1:1
    Learn more
  • Check at every visit

    The participant comes for the drug — photographs the passport again and passes Liveness, and the face is matched against the photo in that passport. If the wrong person came, it is visible before the procedure.

    • A document again
    Learn more
  • A passport and SNILS against databases

    Passport validity, the taxpayer ID (INN) from the passport, and the match of full name and SNILS — at 5 ₽ each. An invalid passport is rejected before enrolment, and payout details are error-free.

    • 5 ₽ per check
    Learn more
  • Authenticity and session log

    Anti-fraud flags a photo of a screen, a photocopy, a pasted-in photo and edits made in an editor. Images, fields and results are saved in the session and exported as JSON — for monitoring and audit.

    • Anti-fraud
    • JSON
    Learn more

From passport to participant record: enrolling in a trial in three steps

An example — the clinical research centre «Olkhovaya Roshcha», a Phase I trial with healthy volunteers.

Step 1

Form and passport

The candidate fills in the form on the recruitment site and photographs the passport. The age is checked against the protocol criteria and the passport number against the site registry. No repeat applications — an invitation to screening.

A candidate photographs a passport on the participant recruitment site
Step 2

Liveness before the sheet

At the site, the coordinator opens a session: the candidate passes Liveness and the face is matched against the passport photo. Only then does the investigator explain the trial and ask the candidate to sign the information sheet.

Liveness and a match of the face against the passport photo before signing the sheet
Step 3

Participant record and code

SNILS and the health insurance policy are recognised, and the full name and SNILS are matched. The participant gets a code; the sponsor's documents receive the code, while passport data stays at the site.

A participant record with a trial code

Someone else's passport, a professional volunteer, the wrong signatory: substitution in trials

Typical schemes, with no reference to specific cases: the check is needed at screening, on a repeat application and at a visit.

  • Screening on someone else's passport

    A candidate fails on age or health and sends a relative's passport. Liveness and a match of the face against the passport photo show that the person showing the document is not its holder.

  • A repeat application under the same document

    A volunteer left a trial a month ago and submits a new application. The passport number is already in the site registry — the coordinator sees the date of the previous participation.

  • Substitution at a visit

    An enrolled participant sends someone else in their place. The document and Liveness checked again at the visit prevent the drug from being given to anyone but the person who signed the consent.

  • A document from a screen or with edits

    Instead of a passport — a photo of a monitor, a photocopy or a scan with a corrected date of birth. Anti-fraud flags such traces before screening.

The electronic information sheet: what is signed via ESIA and what — in NeuroSign

Since 28 December 2025 a patient information sheet may be paper or electronic. The law names the signatures for the electronic sheet, and it is important not to confuse them with the signature on other participant documents. Certification authorities and the enhanced signature — on the page electronic signature and certification authorities; online patient consultations — in telemedicine.

  • Paper sheet

    The participant or legal representative signs the sheet by hand. Before that, NeuroVision confirms that the passport holder is signing — Liveness and a match of the face against the photo in the document.

    • Paper
  • Electronic sheet

    Signed with an enhanced qualified, enhanced non-qualified or simple electronic signature obtained via ESIA. The signature is issued and verified by the site's system; NeuroVision does not replace it.

    • QES · NQES · ESIA
  • Volunteer agreement and compensation

    The participant signs the agreement, supplementary agreements, acts and compensation claims in NeuroSign: passport, selfie, Liveness and an audit trail with document hashes. Such a signature is equal to a handwritten one by agreement of the parties.

    • NeuroSign
  • Remote visit

    If the visit is online, the participant photographs the passport and passes Liveness in the Web SDK or the app — the face is matched against the passport photo, as at the site.

    • Web SDK

The site knows the passport, the sponsor knows the code: where NeuroVision's work ends

  • NeuroVision does

    Recognition of the passport, SNILS, health insurance policy, child's documents and foreign documents. Document anti-fraud. Validity of the passport, taxpayer ID (INN) and SNILS. Selfie, Liveness and a match of the face against the document photo — at screening and every visit. A site participant registry by document number. NeuroSign for agreements and acts.

  • Done by the site and the sponsor

    The investigator — information, consent and the enrolment decision. The site's system — the electronic sheet signed via ESIA or with a QES. The policyholder — the participant code and the insurance contract. The sponsor — the protocol and monitoring by participant codes.

  • What we do not claim

    Signing the information sheet. A shared registry of volunteers across all sites. Recognising a participant by face from a database. Checks for contraindications, pregnancy or military service. Handling medical data and test results.

The course of a trial is set by Federal Law 61‑FZ, the permit and the protocol; NeuroVision checks confirm the document and the person. A clinic's reception desk — on a separate page, AI for diagnostics — in NeuroMed.

Recognition, Liveness and signature for research sites

Document and anti-fraud — in the per-session package, the face — in the «Document + Liveness» package, database checks — at 5 ₽, the signature — in NeuroSign.

Passport, SNILS, child

  • 195+ countries and territories

    A Russian passport and foreigners’ documents

    The passport is recognised from a photo: full name, date of birth, series and number, and date of issue arrive as fields with no retyping. Documents of foreign nationals — 195+ countries and territories.

    from 16 ₽ per document

    Learn more
  • OCR · fields for the participant record

    SNILS and compulsory health insurance policy

    SNILS and the health insurance policy are recognised from a photo in the same session: full name, SNILS number and policy number — as ready fields for the participant record.

    +10 ₽ in the same session

    Learn more
  • OCR · by template

    Birth certificate and representative's documents

    A child's birth certificate and the parent's passport are recognised from a template in one session, and the parent's full name is matched.

    +10 ₽ in the same session

    Learn more
  • Screen, copy, pasted-in photo, editor

    Document anti-fraud

    Flags a photo of a screen, a photocopy, a pasted-in photo and traces of editing — before screening.

    in the package

    Learn more

How much a trial participant check costs

You pay for completed checks, with no subscription fee. A repeat check at a visit is a separate session.

  • Document

    from 16 ₽

    Calculate volume

    Passport recognition and anti-fraud — for the recruitment form and the site registry. At 10,000 documents a year — 18 ₽.

  • Most popular choice

    Document + liveness

    from 29 ₽ per session

    Enable

    Everything in «Document» plus a selfie, Liveness and a match of the face against the document photo — before the sheet and at every visit.

  • Extended

    on request

    Discuss your scenario

    Document, Liveness and database checks in one scenario, installation within the site's perimeter, NeuroSign.

Passport validity, the taxpayer ID (INN) from the passport, and the match of full name and SNILS — at 5 ₽ each, all 16 basic checks — 50 ₽. SNILS, a policy or a birth certificate in the same session — +10 ₽. NeuroSign — on request. All prices are on the pricing page.

How to connect the check to the recruitment site, the participant portal and the site's system

The SDK — for the recruitment site and the participant's app, the API — for the site's system and CROs, the on-premise setup — for sites that do not let participant data leave their perimeter.

Web SDK and mobile SDKs

A ready-made interface for capturing the passport, selfie and Liveness with prompts — on the recruitment site, on the coordinator's tablet and in the participant's app on iOS and Android. Documentation

  • Web SDK
  • iOS and Android
  • REST API
  • A cloud in Russia
  • Docker in your perimeter
  • Software registry entry no. 19972

Test access for 1 month.

Support through a ticket system.

Why research sites choose NeuroVision

One platform for the form, screening, visits and payouts.

Data — from the person who was enrolled

The passport is genuine and valid, the face matched the photo at screening and at every visit, a repeat application is visible by document number, and the volunteer agreement is signed with an audit trail. Everything is recorded in the session.

There is no need to assemble a solution from several vendors and reconcile their responses.

OCR Liveness KYC API

Without manual entry

passport, SNILS and policy as ready fields.

Protected against substitution

Liveness 99.9 %, ISO 30107‑3 / iBeta, document anti-fraud.

Skolkovo — participant

Without medical data

test results and diagnoses do not enter the session.

Russian software

register No. 19972, cloud in Russia or the site's perimeter.

Information sheet, CRO, screening, participant code: a glossary of clinical trials

Terms from the protocol, the CRO contract and a conversation with the sponsor.

Clinical trial
A study of the properties of a medicinal product when used in humans, to obtain evidence of its safety and efficacy.
Clinical trial
Patient information sheet (PIS)
A document with information about the trial and the participant's written voluntary consent. Signed on paper or electronically — with a QES, an NQES or a simple e-signature via ESIA.
Patient information sheet and consent
Screening
An examination of a candidate against the protocol's inclusion and exclusion criteria before the decision on participation.
Screening
Healthy volunteer
A participant without a disease, on whom the safety and tolerability of a drug are studied in the early phases.
Healthy volunteer
Individual identification code
A code that the policyholder assigns to a participant; the participant uses it to receive an insurance payout.
Subject identification code
Sponsor
The organisation that initiates a trial and is responsible for organising it; usually — the drug developer.
Sponsor
CRO, contract research organisation
A company to which the sponsor hands over part of the work: site selection, monitoring, data management.
Contract research organisation
Investigator
A site physician responsible for conducting the trial at their site and for enrolling participants.
Investigator
A legal representative
A parent, adoptive parent, guardian or trustee; signs the sheet for a child or an incapacitated participant.
Legal guardian
Liveness
A check that a live person is in front of the camera, not a photo, a video, a mask or a deepfake.
Liveness detection

Questions about checking clinical trial participants

Yes. Since 28 December 2025 a patient information sheet may be paper or electronic. An electronic one is signed with an enhanced qualified, enhanced non-qualified or simple electronic signature obtained via ESIA. Before signing, NeuroVision confirms that the passport holder is signing.

No. For the electronic sheet the law names enhanced signatures and a simple signature via ESIA. In NeuroSign the participant signs other documents: the volunteer agreement, supplementary agreements, acts and compensation claims.

At every visit the participant shows the passport again and passes Liveness, and the face is matched against the photo in that passport. We do not recognise people from stored face templates — the check is done afresh every time.

Within your site or network — yes, by document number in your participant registry. NeuroVision has no shared registry of volunteers across all sites, and we do not offer searching for a person by face in a database.

A birth certificate and the parent's passport are recognised in one session, and the parent's full name is matched automatically. The sheet for a child is signed by a parent or adoptive parent, and the enrolment decision is made by the investigator.

That is determined by the site's access scheme. The service returns the check result to the site, and only the participant code can be passed into the sponsor's documents. With on-premise installation the data stays on the site's servers.

A passport may be invalid, and payout details may contain an error. Passport validity, the taxpayer ID (INN) from the passport, and the match of full name and SNILS cost 5 ₽ each and rule this out before enrolment.

Yes. We recognise documents from 195+ countries and territories, with the full name in Latin and Cyrillic letters, as in the document. A residence permit or temporary residence permit — as an additional document for 10 ₽.

No. The check session receives documents and a selfie, without test results, diagnoses or trial records. The data is processed on the site's instructions.

Yes, the technology integrates with the Unified Biometric System. Connection to the system and the legal grounds for biometric identification are provided by the site or its operator.

In the NeuroVision cloud on servers in Russia — images are kept free for 3 months, then by tariff. With on-premise installation — on the site's servers only.

The recruitment site and the participant's app — via the Web SDK and the SDK for iOS and Android, the site's system — via the REST API. Test access — 1 month.

We will select the checks for your research site

Tell us which phases you run, whether you have healthy volunteers and children, how many screenings a month, whether you need remote visits and where the data must be stored. We will demonstrate the check on your documents.

Can't put your request into words? Book a call and our team will contact you at a convenient time

Book a call

The company is included in the register of IT companies and the register of personal data operators of the Russian Ministry of Digital Development.

Address: Moscow, Presnenskaya Embankment 12 — Moscow City business centre, Federation Tower. Nearest metro stations: Delovoy Tsentr and Mezhdunarodnaya.