Healthcare · Moraph software

Clinical Trial Patient Recruitment App

Recruit, consent and keep trial participants with one patient app and one site view

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Overview

What you are buying

The Clinical Trial Patient Recruitment App gives prospective and enrolled participants a mobile app for pre-screening, electronic consent, visit reminders and reporting how they feel, and gives study sites a workspace to follow up. Consent is captured with the IRB-approved materials and version, and participant-reported symptoms reach the site team for review rather than being judged by the app. Every consent, report and decision keeps its record for monitors, auditors and inspectors.

The problem it solves

Many trials struggle to find eligible participants and to keep them once enrolled. Pre-screening happens over the phone and in spreadsheets, consent is a long paper form explained in a single visit, and reconsent after an amendment depends on someone remembering. Between visits, participants have no easy way to report a new symptom, so possible adverse events surface late, if at all. When a monitor asks which consent version a participant signed, the answer is in a binder.

  • Pre-screening is manual and referrals from outreach are hard to track
  • Paper consent is hard to understand and harder to keep current after amendments
  • Participants miss visits and drop out without the site knowing why
  • Symptoms between visits are reported late or not at all

Who uses it

  • Clinical research sites at hospitals, academic medical centers and site networks
  • Study coordinators and principal investigators running enrollment and follow-up
  • Sponsors and CROs who want consistent recruitment and retention across sites
  • Research compliance and IRB offices responsible for consent
  • Participants and their caregivers, who use the app

Requirements it supports

FDA electronic records and signatures (21 CFR Part 11)FDA protection of human subjects and informed consent (21 CFR Part 50)Federal Policy for the Protection of Human Subjects, the Common Rule (45 CFR Part 46)IND safety reporting (21 CFR 312.32 and 312.64)ICH E6 Good Clinical PracticeHIPAA Privacy Rule authorizations for research (45 CFR 164.508 and 164.512(i))

The product supports these requirements; meeting them remains your organization’s responsibility.

See how it works

A short walkthrough

Illustrative screens with fictional sample data. They show the workflow, not any client’s data or configuration, and the layout of the product itself differs. A live demonstration uses the product with sample data.

  1. Step 1

    Referral queue

    Coordinators see each pre-screened referral, where it came from and whether anyone has called yet.

    ReferralStudySourcePre-screenAgeStatus
    RF-3021Study EX-201 (fictional)Clinic flyerLikely eligible1 dayNew
    RF-3018Study EX-201 (fictional)Registry linkLikely eligible4 daysNot yet contacted
    RF-3011Study EX-114 (fictional)Physician referralNeeds review5 daysContacted
    RF-3007Study EX-201 (fictional)WebsiteNot eligible6 daysClosed
    Coordinators see each pre-screened referral, where it came from and whether anyone has called yet.

  2. Step 2

    Consent in sections

    Participants work through consent a section at a time, with questions flagged for the consent discussion.

    Participant 0457 · Study EX-201 consent, version 3

    Version
    3, IRB-approved
    Sections read
    9 of 9
    Comprehension questions
    5 of 6 correct
    Questions for the team
    1 flagged
    Signed by participant
    Yes
    Countersigned
    Waiting

    Flagged question

    • Section 6: Will I be paid for travel to visits?
    Participants work through consent a section at a time, with questions flagged for the consent discussion.

  3. Step 3

    Visit schedule

    The participant's schedule comes from the protocol, with reminders and missed visits visible to the site.

    VisitWindowReminderStatus
    ScreeningDay -14 to -1SentCompleted
    BaselineDay 1SentCompleted
    Week 4Day 26 to 30SentMissed
    Week 8Day 54 to 58ScheduledUpcoming
    The participant's schedule comes from the protocol, with reminders and missed visits visible to the site.

  4. Step 4

    A symptom report

    When a participant reports a symptom, the site follows up and the investigator records the assessment.

    Participant 0457 · Headache and dizziness

    1. Symptom reported in app, moderateParticipant
    2. Report opened and participant calledStudy coordinator
    3. Follow-up notes recordedStudy coordinator
    4. Assessed as adverse event, non-seriousInvestigator
    5. Entered for sponsor per protocol; reference recordedStudy coordinator
    When a participant reports a symptom, the site follows up and the investigator records the assessment.

  5. Step 5

    Reconsent after an amendment

    When a new consent version is approved, the app shows who still needs to reconsent.

    ParticipantSigned versionCurrent versionSentStatus
    045734YesSigned
    046234YesNot yet signed
    047034YesDiscussion booked
    048144Not neededCurrent
    When a new consent version is approved, the app shows who still needs to reconsent.

  6. Step 6

    Site retention view

    Investigators see enrollment, adherence and open reports across their participants.

    Example University Hospital (fictional) · Study EX-201

    Referrals
    64
    Consented
    22
    Active participants
    19
    Withdrawn
    3
    Visits missed this month
    4
    Reports awaiting assessment
    2

    Needs attention

    • Participant 0462 has not reconsented to version 4
    • Participant 0457 missed the week 4 visit
    • Two reports waiting for investigator assessment
    Investigators see enrollment, adherence and open reports across their participants.

Workflows

The principal workflows

  1. Pre-screen

    People who respond to outreach complete a short, study-specific questionnaire in the app. Responses go to the site as referrals; the coordinator, not the app, decides who to contact and who is eligible.

    • Prospective participant opens the study listing from an approved link
    • Agrees to the pre-screening privacy notice
    • Answers the IRB-approved pre-screening questions
    • Referral appears in the site's queue with responses
    • Coordinator contacts the person and records the outcome

  2. Consent

    Participants read the IRB-approved consent in sections, with plain-language summaries, glossary terms and optional videos, then sign electronically. The site investigator or designee confirms the consent discussion and countersigns.

    • Coordinator sends the current approved consent version
    • Participant reviews each section and answers comprehension questions
    • Questions are flagged for the consent discussion with the site
    • Participant signs; site designee confirms and countersigns
    • Signed copy available to the participant and filed for the site

  3. Stay in the study

    Between visits the app reminds participants of visits and tasks, shares study updates the site approves, and lets them message the study team, so problems surface before a participant drops out.

    • Visit schedule loaded from the protocol's schedule of activities
    • Reminders sent before visits and tasks
    • Participant confirms, reschedules or messages the team
    • Missed visits and unanswered tasks flagged to the coordinator
    • Reconsent prompted when an amendment approves a new consent version

  4. Report how they feel

    Participants can report new symptoms, medicines or hospital visits at any time. Reports reach the site team for review; the investigator decides whether something is an adverse event and handles reporting to the sponsor.

    • Participant describes the symptom, when it started and how severe it feels
    • App shows study team contact details and when to seek urgent care
    • Report appears in the site's review queue
    • Coordinator follows up and the investigator assesses it
    • Assessment and any sponsor report reference recorded

Roles and permissions

Who does what in the product

Each role below is a starting point. During implementation we set them up to match your teams, and every action anyone takes is recorded in the audit trail.

Participant

Prospective participant, enrolled participant, caregiver or legally authorized representative

Learns about the study, decides whether to take part, and stays in touch with the study team.

Sees

  • Study information and the consent version they are asked to sign
  • Their own visit schedule, tasks and messages
  • Their signed consent and their own reports

Does

  • Completes pre-screening questions
  • Reviews and signs consent, or declines
  • Confirms or asks to reschedule visits
  • Reports symptoms, new medicines or hospital visits
  • Messages the study team
  • Withdraws from app features or asks the site about withdrawing from the study

Cannot

  • See other participants' information
  • Change a report after the site has started reviewing it; they can add to it
  • Receive medical advice from the app itself
Approvals
None; their consent is confirmed by the site investigator or designee.
Notified about
Visit and task reminders, messages from the study team, and requests to review a new consent version.

Study coordinator

Clinical research coordinator, research nurse, study assistant

Runs the day-to-day work of enrollment and follow-up for their studies.

Sees

  • Referrals and pre-screening responses for their studies
  • Consent status and versions for their participants
  • Visit schedules, missed tasks and messages
  • New symptom and event reports

Does

  • Contacts referrals and records outcomes
  • Sends consent and holds consent discussions
  • Countersigns consent where delegated
  • Follows up on reports and records the conversation
  • Reschedules visits and messages participants
  • Prompts reconsent after amendments

Cannot

  • Assess whether a report is an adverse event unless delegated by the investigator
  • Edit a signed consent or a participant's report
  • Publish a consent version that is not marked IRB-approved
Approvals
Their consent countersignatures follow the delegation log; event assessments go to the investigator.
Notified about
New referrals, consents signed or questions raised, new reports, missed visits and reconsent due.

Investigator

Principal investigator, sub-investigator

Holds medical and regulatory responsibility at the site: confirms consent and assesses what participants report.

Sees

  • All participants at their site for their studies
  • Every report and the coordinator's follow-up
  • Consent records and the delegation log

Does

  • Confirms and countersigns consent
  • Assesses reports for seriousness, relatedness and expectedness
  • Records whether a report was sent to the sponsor and its reference
  • Reviews retention and withdrawal reasons

Cannot

  • Delete a participant's report
  • Change a consent after signature
Approvals
Signs off event assessments and consent; their decisions are final for the site.
Notified about
Reports flagged by the coordinator, reports describing a hospital visit, and consents awaiting countersignature.

Sponsor or CRO study manager

Clinical trial manager, study start-up lead, CRO project manager

Follows recruitment and retention across sites to plan support and outreach.

Sees

  • Referrals, consents, enrollment and withdrawals by site, without direct identifiers
  • Consent version adoption across sites

Does

  • Reviews site performance on recruitment and retention
  • Supplies study materials for each site's IRB process
  • Exports aggregate reports

Cannot

  • See participant identities unless the consent and contract permit it
  • Contact participants directly
  • Change site records
Approvals
Their access scope is agreed in the contract and approved by each site.
Notified about
Weekly enrollment summaries and new consent versions published at sites.

Monitor or auditor (read-only)

Clinical research associate, quality assurance auditor, inspector under temporary access

Verifies consent and source records without changing them.

Sees

  • Consent records, versions and signatures within scope
  • Reports, follow-up notes and investigator assessments
  • The audit trail

Does

  • Reviews records for the participants and dates in scope
  • Exports records, with each export logged
  • Leaves monitoring notes where the site enables them

Cannot

  • Change, sign or delete anything
  • Keep access after its end date
Approvals
Access is approved by the site administrator or investigator, with a scope and an end date.
Notified about
Nothing by default.

Administrator

Research IT administrator, clinical research office systems lead

Sets up studies and users and keeps consent versions under control.

Sees

  • Studies, sites, users and roles
  • Consent versions and their approval status
  • The record of configuration and permission changes

Does

  • Creates studies and loads approved consent and questionnaire content
  • Records IRB approval for each consent version
  • Assigns users to studies and roles from the delegation log
  • Runs access reviews

Cannot

  • See participant reports unless also assigned a study role
  • Mark their own content as approved without a second person
Approvals
Publishing a consent version requires a second person to confirm the IRB approval record.
Notified about
Consent versions waiting for publication and access reviews due.

Permissions at a glance

ActionParticipantCoordinatorInvestigatorSponsorMonitorAdmin
Complete pre-screeningOwn work onlyNo accessNo accessNo accessNo accessNo access
Work referralsNo accessFullFullNo accessNo accessNo access
Sign consentOwn work onlyNo accessNo accessNo accessNo accessNo access
Countersign consentNo accessOwn work onlyFullNo accessNo accessNo access
Publish a consent versionNo accessNo accessApprovesNo accessNo accessFull
Submit a symptom reportOwn work onlyNo accessNo accessNo accessNo accessNo access
Follow up on a reportNo accessFullFullNo accessNo accessNo access
Assess an adverse eventNo accessNo accessFullNo accessNo accessNo access
Message participantsOwn work onlyFullFullNo accessNo accessNo access
View aggregate enrollmentNo accessView onlyView onlyView onlyView onlyView only
View the audit trailNo accessNo accessView onlyNo accessView onlyView only
Manage users and rolesNo accessNo accessApprovesNo accessNo accessFull
  • Full
  • Own work only
  • Approves
  • View only
  • No access

How access is controlled

  • The app never decides eligibility or whether a report is an adverse event. Coordinators and investigators make those decisions, and each one is recorded with the person and time.
  • Site roles follow your delegation log: a coordinator countersigns consent only if delegated, and each study can have its own role assignments.
  • Sponsors and CROs see aggregate and coded data by default. Access to identifiable information follows the participant's consent and authorization and your contract.
  • Monitors, auditors and inspectors get temporary read-only access with a defined scope and an end date, rather than shared accounts.

Features

What it does

Study-specific pre-screening

Questionnaires built from the IRB-approved wording for each study, with referrals tracked from first response to outcome.

Electronic consent

Consent presented in sections with summaries, glossary terms, comprehension questions and optional media, then signed electronically.

Consent version control

Each signature is tied to the exact approved consent version, and reconsent is prompted when a new version is approved.

Remote or in-person consent

Consent can be completed at the site on a tablet or remotely with a scheduled discussion, as your protocol and IRB allow.

Visit schedule and reminders

Visits and tasks from the schedule of activities, with reminders by app notification, text or email.

Symptom and event reporting

Participants report symptoms, new medicines and hospital visits between visits, routed to the site for investigator review.

Secure messaging

Participants and the study team exchange messages in the app, kept with the participant's study record.

Site workspace

Coordinators see referrals, consent status, upcoming visits, missed tasks and new reports for their participants in one place.

Accessible design

Large text, screen reader support and plain-language content, with languages added as the IRB approves translations.

Caregiver access

A legally authorized representative or caregiver can be invited where the protocol and consent allow.

Retention insights

Missed visits, unanswered tasks and withdrawals by reason, so sites can see who may need a call.

Inspection-ready records

Signatures, consent versions, reports and site decisions kept with a time-stamped audit trail, exportable for monitors and inspectors.

Integrations

How it connects to your systems

Connects toHowWhat flows
Clinical trial management systemStudies, sites, visit schedules and enrollment status exchanged with your CTMS.In: studies, sites and schedules. Out: enrollment and consent status.
Electronic data captureParticipant-reported data the protocol designates can be passed to your EDC for the sponsor's dataset.Out: coded participant-reported data and consent dates.
EHRWhere the site chooses, consent documents and research participation flags can be filed to the EHR.Out: signed consent document and participation status.
eRegulatory and eTMFApproved consent versions and signed consent records filed to the site's regulatory binder or trial master file.In: approved versions. Out: signed consent records.
Outreach and referral sourcesStudy links for outreach campaigns, registries and physician referrals, so each referral's source is recorded.In: referral source tags.
Messaging servicesReminders by text and email through the messaging providers configured for your organization.Out: reminder messages without clinical detail.
Single sign-onSite and sponsor staff sign in through your identity provider (SAML or OpenID Connect).In: user identity and group membership.

Each integration is confirmed in discovery and specified in the design. See how an engagement progresses.

Security and privacy

How your data is protected

Business associate agreement

Where PHI is involved, Moraph signs a business associate agreement with the covered entity.

Participant sign-in

Participants sign in with multi-factor verification and device protections, and staff sign in through your identity provider.

Role-based access

What each person can see follows their role and study; sponsors see coded data unless consent and contract allow more.

Encryption and keys

Data is encrypted in transit and at rest, with keys Moraph staff cannot use without explicit, time-bound authorization.

Complete audit trail

Every view, signature, report, assessment and export is logged with the person and time and cannot be edited.

Data residency

Data stays in the hosting region you choose: the United States, the United Kingdom or Australia.

Company-wide controls, independent audits (SOC 2 Type II and ISO/IEC 27001) and data residency are described in our Trust Center, where you can request the evidence pack.

Reporting

What you can report on

11 standard reports, grouped by who uses them. Each shows who it is for, how it can be broken down, how it is delivered and what it is used for. The data behind them is also available to your own reporting tools.

Recruitment

Referral funnel

For coordinators, investigators, sponsor study managers

Pre-screens started, completed, referred, contacted, consented and enrolled.

Break down by
Study, Site, Referral source, Period
Delivered as
Live dashboard; CSV export
Used for
Seeing where prospective participants drop out and which outreach works.

Referral follow-up

For coordinators

Referrals waiting for contact, with their age and outcome so far.

Break down by
Study, Coordinator, Age band
Delivered as
Live view
Used for
Making sure every interested person hears back.

Consent

Consent status

For coordinators and investigators

Each participant's consent status, version signed and countersignature.

Break down by
Study, Site, Version, Status
Delivered as
Live view; CSV and PDF export
Used for
Confirming every participant has valid, current consent.

Reconsent tracker

For coordinators, investigators, research compliance

Participants who need to reconsent after a new version is approved, and whether they have.

Break down by
Study, Version, Site, Status
Delivered as
Live view; scheduled email
Used for
Completing reconsent after amendments.

Comprehension questions

For investigators and research compliance

Which consent sections prompted questions or wrong answers to comprehension checks.

Break down by
Study, Section, Version
Delivered as
Live dashboard
Used for
Improving consent materials for the next IRB submission.

Retention and safety

Visit adherence

For coordinators and sponsor study managers

Visits completed, rescheduled and missed, and tasks left unanswered.

Break down by
Study, Site, Visit, Period
Delivered as
Live dashboard; CSV export
Used for
Finding participants who may be at risk of dropping out.

Withdrawals

For investigators and sponsor study managers

Withdrawals and losses to follow-up with the reason recorded by the site.

Break down by
Study, Site, Reason, Period
Delivered as
Live view; CSV export
Used for
Understanding why participants leave.

Participant reports

For coordinators and investigators

Symptom and event reports with their follow-up and investigator assessment status.

Break down by
Study, Site, Status, Report type
Delivered as
Live view
Used for
Making sure every report is reviewed and assessed.

Audit and inspection

Consent audit record

For monitors, auditors, inspectors

For a selected participant, every consent version presented, signed and countersigned, with times and signers.

Break down by
Participant, Study, Version
Delivered as
On request; PDF export
Used for
Answering monitoring and inspection requests about consent.

Audit trail extract

For auditors and research compliance

Who viewed, created, signed, assessed or exported what, and when.

Break down by
Participant, User, Action, Date range
Delivered as
On request; CSV and PDF export
Used for
Providing evidence for audits and inspections.

Access review

For administrators and investigators

Each staff member's roles by study, compared with the delegation log.

Break down by
Study, Role, Site
Delivered as
On request; CSV export
Used for
Periodic certification that access matches delegation.

Exports, access and evidence

  • Reports can be exported to CSV, and consent and audit reports to PDF. Reports can be scheduled to arrive by email for the people entitled to see them.
  • Sponsor and CRO reports use aggregate or coded data unless the participant's consent and your contract allow identifiable detail.
  • Reports respect each viewer's role and study: a coordinator sees their own studies, and an investigator sees their site.
  • Enrollment and consent data can be delivered to your CTMS or data warehouse for reporting alongside other study data.
  • Audit reports can be run as of a past date and give the same result each time. Running and exporting a report is itself recorded in the audit trail.

Deployment

Where and how it runs

Moraph cloud

Hosted and operated by Moraph in the United States region, with United Kingdom and Australia regions for sites outside the US.

Participant app

Participants use the app on iOS or Android, or a mobile web version for those who prefer not to install an app.

Dedicated environment

A single-tenant environment for sponsors or institutions whose policies require isolation, scoped in the proposal.

Security controls, independent audits and data residency are set out in our Trust Center. Engagement models and what drives a quotation are on Working with Moraph.

Implementation

What a rollout involves

The general phases are on Working with Moraph. For this product, they involve the following.

Study setup

We load each study's schedule of activities, pre-screening questions and consent content as approved by your IRB. We need the approved documents and a study contact.

Consent build

Consent is laid out in sections with summaries and comprehension questions, and the electronic version is provided for your IRB's review where it requires one.

Roles and delegation

Site roles are configured from your delegation log, with sponsor and monitor access scoped by contract.

Integrations

Connections to your CTMS, EDC, eRegulatory system and single sign-on are configured and tested.

Validation support

Moraph provides validation documentation and test evidence to support your computer system validation and Part 11 assessment; the validation decision is yours.

Site training and launch

Coordinators and investigators are trained on their workflows, and participant help content is reviewed before the first study goes live.

Limitations

What it does not do

Worth knowing before you evaluate it.

  • The app does not decide eligibility, enroll participants or give medical advice. Site staff make those decisions.
  • It does not determine whether a report is an adverse event or submit safety reports to sponsors, IRBs or the FDA; investigators and sponsors do.
  • Consent content and every change to it must be approved by your IRB before use; the app records the approval but does not grant it.
  • Computer system validation and Part 11 compliance for your use are your organization's decisions; Moraph provides supporting documentation.
  • It is not an electronic data capture system or a CTMS; it connects to the ones you use.
  • It is not intended for emergencies. Participants are directed to call emergency services or their study team for urgent symptoms.
  • Languages are added as approved translations are supplied; machine translation is not used for consent.
  • Participants need a smartphone or web access; sites keep paper or in-person options for those without one.

Evaluation checklist

What to test in a demonstration or pilot

Questions worth putting to us, and to any other vendor you are considering.

  1. Build one of your current consent forms in the app and review it with your IRB office
  2. Ask a few volunteers to complete the consent flow on their own phones and gather their feedback
  3. Walk through a symptom report from submission to investigator assessment
  4. Check that a new consent version triggers reconsent for the right participants
  5. Review what a sponsor user can and cannot see
  6. Ask a monitor to pull the consent audit record for a test participant

Questions

Frequently asked questions

Does the app replace the consent discussion?

No. It presents the approved consent and records the signature, but the site still holds the consent discussion and the investigator or designee confirms it.

Who decides whether a participant report is an adverse event?

The investigator. The app routes reports to the site and records the assessment and any reference to the sponsor's safety system.

Can sponsors see participant names?

Not by default. Sponsors see aggregate and coded data unless the participant's consent and your contract allow identifiable detail.

Is it Part 11 compliant?

It provides controls such as electronic signatures, audit trails and version control, and Moraph supplies validation documentation. Whether your use meets Part 11 is assessed and decided by your organization.

How is it priced?

As a subscription, usually by study or site, with study setup charged separately. See Working with Moraph for what drives a quotation.

Is there an accessibility conformance report?

Ask for one through the procurement request form at /how-to-buy/request, naming the version you are evaluating.

Next steps

Evaluate Clinical Trial Patient Recruitment App

Book a demonstration

See the product working with sample data, focused on your workflows.

Request a demonstration

Request a technical briefing

Architecture, integrations, security and hosting, with our engineers and your technical team.

Request a briefing

Factsheet

This page on two sides, to share with colleagues or add to your evaluation file.

Open the factsheet

Buying through a formal procurement? See How to buy for purchasing routes, accessibility conformance reports and company information. Documentation: Clinical Trial Patient Recruitment App guides on docs.moraph.com (getting started and security guides are public; setup, administration and integration guides are for client accounts). Support: Clinical Trial Patient Recruitment App support guide.

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