Clinical Trial Patient Recruitment App

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.

Who it’s for

• 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

1. Pre-screenPeople 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.
2. ConsentParticipants 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.
3. Stay in the studyBetween 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.
4. Report how they feelParticipants 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.

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.

Participant

Pre-screens, consents, gets reminders, and reports symptoms through the app

Study coordinator

Works referrals, runs consent, follows up on reports and missed visits

Investigator

Confirms consent, assesses reported events and owns medical decisions

Sponsor or CRO study manager

Sees enrollment and retention across sites without identifying details

Monitor or auditor (read-only)

Reviews consent and source records within scope

Administrator

Sets up studies, consent versions and user access

Clinical trial management system

Studies, sites, visit schedules and enrollment status exchanged with your CTMS.

Electronic data capture

Participant-reported data the protocol designates can be passed to your EDC for the sponsor's dataset.

EHR

Where the site chooses, consent documents and research participation flags can be filed to the EHR.

eRegulatory and eTMF

Approved consent versions and signed consent records filed to the site's regulatory binder or trial master file.

Outreach and referral sources

Study links for outreach campaigns, registries and physician referrals, so each referral's source is recorded.

Messaging services

Reminders by text and email through the messaging providers configured for your organization.

Single sign-on

Site and sponsor staff sign in through your identity provider (SAML or OpenID Connect).

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.

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.

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.

• 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.

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