Help Centre

The Getting Started series walks you through setting up a study on Trialflare from scratch. It covers trial information, data types, stages, participants, eConsent, data collection, compliance, team management, sites, eTMF, polls, and wearables — in that order.

If you're new to Trialflare, work through the 13 parts in sequence. If you have REDCap experience, the terminology will feel familiar — see the Definitions article for a quick mapping of core concepts.

Every study starts with three building blocks: a trial code, data types, and stages.

Every person in a study needs one participant record. Trialflare supports two engagement models: self-reporting (participants log in and submit their own data) and staff-facilitated (team members enter data on a participant's behalf).

Single participant: Add participants one at a time as recruitment progresses. Assign an ID and optional password. You can reset forgotten passwords at any time from the participant record.

Bulk onboarding: For large enrolments or pre-generated IDs, use the multiple-participant workflow. When creating participants with passwords in bulk, Trialflare exports a CSV of generated passwords — keep this securely.

Study arms: Define intervention groups in advance. New participants can then be assigned automatically using blocking or round-robin distribution. Randomisation is also supported during creation.

Security tip: Use distinctive participant IDs rather than sequential numbers — e.g. 8L3HN3 or fuzzy-happy-llama — and combine with individual passwords and a unique trial code.

Once participants are created, they need to access the platform to submit data. Trialflare uses a combination of trial code, participant ID, and optional password to verify that submissions come from the intended person — open URLs alone aren't enough.

With eConsent enabled: Participants cannot access or submit any data until they have completed the informed consent process, even if they have correct credentials.

Without eConsent: Participants log straight in using their ID and password and proceed to complete available stages.

Distribution methods: Share credentials via QR codes on packaging, stickers, email (use a study-specific address), or directly within participant information sheets alongside app store links.

eConsent ensures participants understand the study's nature, purpose, risks, and benefits before they provide any data. The contents of your informed consent form should have been reviewed by an appropriate ethics committee.

Enable eConsent via a tickbox in the trial settings, then complete the following sections:

• Participant Information Sheet (PIS) — study background, purpose, overview, and potential risks or benefits
• Eligibility criteria — requirements that participants must initial to confirm they understand and meet
• Standalone conditions — additional items requiring initials, such as awareness of withdrawal rights

Saving the form creates a versioned record. When you update the consent form, a new version is created and existing participants must re-consent. All consent logs are stored and downloadable.

Once eConsent is enabled, participants are presented with the consent form immediately after logging in for the first time. They must work through the Participant Information Sheet, initial each eligibility criterion and standalone condition, and provide a final signature before they can access any study data or stages.

Participants can revisit their signed consent at any time from within the app. If the consent form is updated to a new version, they are prompted to review and re-consent before continuing.

Once participants are onboarded, they see all available stages in their dashboard. Stages they cannot yet complete show a padlock icon — typically because a future recurrence hasn't become available yet.

One-off submissions: After completing a one-time stage, participants see a green checkmark and cannot resubmit.

Recurring submissions: Only the current recurrence is available. The next week's entry appears automatically once the previous one is submitted.

Ad hoc submissions: Unlimited entries for items like food diaries, image uploads, or health assessments. Participants can submit as many times as needed.

All participant responses are available in real time from the admin platform. You can view data at the participant level (individual responses), at the stage level (all responses to a particular form), or export a full dataset.

Data exports are available as CSV or Excel. Exports include all submitted values, timestamps, and participant identifiers — formatted cleanly for analysis or regulatory submission.

In decentralised research, participants often forget to submit required data. Trialflare provides several tools to drive compliance and maintain engagement.

Automatic messages: Set up general reminders — for example, prompting participants to take their intervention at a specific time each day. Configure these via the Messages tab. Participants using the mobile app can receive push notifications; those with push enabled appear with a green "PUSH" label in the participant overview.

Stage-specific reminders: Notify participants about upcoming or outstanding tasks. Set these per-stage via Stages > Edit > Push reminders. These are response-driven — once a participant submits, reminders for that stage stop. Use the %n placeholder to personalise recurring reminders (e.g. "Week 1", "Week 2").

Instant messaging: Send secure direct messages to participants who have the Trialflare app installed. Ideal for time-sensitive prompts or follow-up on missing data.

Team members with the appropriate permissions can enter or amend participant data directly in the admin platform — every action is audit-logged for compliance.

• Adding data: Navigate to a participant's Responses tab and select "Add data for this date"
• Amending records: Edit existing submissions with a mandatory sign-off note; the full amendment history is logged
• Adding notes: Document information outside standard data collection using the "New note" button in the Participant Information section

Use section dividers in form design to organise larger eCRFs clearly for staff entering data at a site visit.

Trialflare distinguishes between team members (all users in your account) and collaborators (team members assigned to a specific trial). Add users via Team > Users, then assign them as collaborators via Trial Settings > Collaboration.

Multi-site studies: Create Sites to represent different physical locations — universities, partner organisations, clinics. Assign team members to specific sites; site staff only see participants allocated to their location, while the study host retains full visibility across all sites. Participants are assigned to a site at enrolment.

This structure supports complex multi-centre trials while keeping data access appropriately scoped to each location.

The Documents section manages all project-related files at both the trial and site level. It supports version control and approval workflows — making it suitable for use as an electronic Trial Master File (eTMF).

Upload protocol documents, ICFs, SOPs, and site files. Assign approval responsibilities to specific team members with the appropriate document approval permission. All upload, version, and approval events are audit-logged.

Stages can be configured as anonymous polls — no login required. These are useful for screening surveys, event feedback, or open recruitment. Responses are collected without being linked to a participant account.

Generate a branded QR code for any public stage and display it on packaging, posters, or presentations. Participants scan the code to open the form directly in their browser. QR code styling (colours, logo) is configured in Team > Branding.

Trialflare integrates with Garmin to collect real-world health data continuously — sleep, stress, heart rate, steps, calories, pulse oximetry, body battery, and activity data (running, cycling, swimming, strength training). Data collection capability varies by device.

Admin setup: Enable wearable support via Settings > Integrations > Garmin.

Participant setup: Participants need an existing Garmin device and a free Garmin Connect account. They connect by tapping Connect in the web or mobile app, authenticating with Garmin, and authorising data sharing.

Monitoring: A blue indicator on the Participants tab shows active Garmin connections. Wearable data appears in the "Wearables Responses" tab within each participant record as it syncs from the cloud.

Trialflare includes integrated video calling — no external meeting software required. Access requires Trial Admin status or the "Create participant meetings" permission. Meetings are billed per participant-minute and transcription-minute used.

Creating a meeting: From a participant's profile, go to the Meetings tab. Provide a title, set a date and time (links are valid for 24 hours), and select which team members will attend. The system automatically notifies the participant via the Trialflare app, email, SMS, or WhatsApp; staff receive calendar invitations compatible with standard clients.

Joining: Meetings run in any web browser — no download needed. Staff join as hosts with moderator controls; participants use a non-host link that activates once a host enters.

Recording and transcription: Hosts can enable recording and live transcription during the call. Transcriptions are processed after the call and can be downloaded from the participant's Meetings tab.

Seastorm Limited (the company behind Trialflare) operates as a Data Processor under GDPR. You, as the study operator, are the Data Controller responsible for managing your participants' data.

• Legal basis: Consent — participants receive a privacy notice during registration and at key journey points
• Data retention: 30-day backup retention policy
• Encryption at rest: AES-256 for databases and backups
• Encryption in transit: TLS 1.3 with TLS 1.2 fallback
• Data location: All primary data and backups processed and stored within European data centres, with core operations in the UK
• Staff access: Role-based access control with least-privilege assignment; regular security training for all staff
• Auditing: Quarterly penetration testing and annual external security assessments
• Subprocessors: Seven subprocessors including AWS, Azure, Mailgun, and MessageBird

Contact the Data Protection Officer at dpo@seastorm.co. To raise a data protection complaint under the Data (Use and Access) Act 2025, write to dataprotection@seastorm.co.

Trialflare undergoes rigorous and regular certification and audit to ensure company and customer data is fully safeguarded. Seastorm Limited currently holds the following certifications:

• Cyber Essentials
• Cyber Essentials Plus
• IASME Cyber Assurance (Level 1)

Cyber Assurance is a meaningful substitute for international standards such as ISO 27001, incorporating comparable processes, protocols, and security controls.