Clinical Trial Patient Recruitment App

Principal workflows

• 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.
• 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.
• 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.
• 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.

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

Reporting

• Referral funnel from pre-screen to enrollment
• Consent status and versions signed
• Reconsent due after amendments
• Visit adherence and missed tasks
• Participant reports and their review status
• Consent audit records for monitors and inspectors

Features

• 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

• 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).

Deployment

• 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 and privacy

• 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.

Limitations

• 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.

Next steps

Book a demonstration or a technical briefing at www.moraph.com/solutions/clinical-trial-patient-recruitment-app. Purchasing routes and company information: www.moraph.com/how-to-buy.