A foundation that starts a natural history study or funds a first trial usually has a small team, a scattered patient community and no IT department. Capture gives you eConsent, caregiver questionnaires, an eCRF and an audit trail in one study, with Part 11-aligned controls. Build it in the free sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Enrolled
63
Countries
9
Consent fully executed
61 of 63
Overdue diaries
4
76 percent
65 percent
across 5 sites
What a rare disease foundation needs from its software
The foundation as research organiser
Rare disease foundations sit in an unusual place in the research system. They are often founded by families, they know the patient community better than anyone, and they hold the relationships with the few clinicians who treat the condition. That puts them in a position to run a natural history study, build a patient registry, or sponsor the first interventional trial when no company will. The thresholds that define rare vary by region: in the United States a rare disease is commonly defined as affecting fewer than 200,000 people, and in the European Union as affecting no more than 5 in 10,000. Either way the cohort is small and spread across many countries and clinics.
That shape drives the software needs. A cohort of a few dozen to a few hundred people cannot be recruited from one hospital, so data arrives from several sites in different time zones, entered by coordinators who may support many unrelated studies. The foundation itself may have one or two staff who manage the study alongside fundraising. Spreadsheets and survey tools work for the first month and then start to hurt: no audit trail for who changed a value, no query process, consent stored as scanned PDFs, and a registry that cannot be defended when a regulator or a company asks where the numbers came from.
Regulators commonly welcome well-run natural history data because it describes how a condition progresses without treatment, which helps with choosing endpoints and sizing later trials. That only holds when the data is trustworthy. The practical test is simple: can you show who entered each value, when, and why it changed, and can you export the dataset with a dictionary that a statistician you have never met can read? Capture provides that from the first record.
A natural history study usually has annual or twice-yearly visits, a set of clinician-rated assessments, laboratory or imaging data, and patient or caregiver questionnaires between visits. Build it as a schedule of visits with eCRF forms for the clinic data and ePRO tasks for the questionnaires. When the foundation later supports an interventional study, the forms for demographics, medical history and adverse events carry over in structure, and you add randomization if the design needs it. See natural history study software for the design pattern.
Participants and families
Consent is the first remote step. With eConsent the participant, or the parent or Legally Authorized Representative, signs on screen after confirming a one-time code sent by email, the document is hashed to the exact text that was signed, and the site countersigns with password re-authentication. The consent is only fully executed after that countersignature. Optional witness and LAR signatures are supported, and the signed consent exports as a PDF with the signature data, timestamps and audit trail. A pediatric assent template and a long-term follow-up consent template are available under consent templates and long-term follow-up.
Outcome reporting in rare disease is often done by the caregiver. A parent-proxy ePRO template shows how to structure a questionnaire answered by a parent about a child, and the ePRO module sends the task as a link that opens in the phone browser, with no app to install, and reminders you control. Your team supplies the wording; if you use a licensed instrument, the licence stays with your study documents, and Capture does not supply or verify licences.
For recruitment, QR-code enrollment lets a clinic or a patient meeting hand out a study-specific or site-specific code, and site-level participant numbering keeps identifiers clear across countries. Site coordinators see participant names in their own portal while researchers see coded IDs, so the foundation can review data without handling identifiable information.
Need to build
| What the foundation needs | What it looks like | Where it lives in Capture |
|---|---|---|
| Remote consent for families | Parent or LAR signs, clinician countersigns, signed PDF kept | eConsent with LAR and witness options |
| Annual clinic visit data | Clinician-rated scales, vitals, labs, medical history | Visit eCRF forms from the template library, e.g. medical history |
| Caregiver and participant diaries | Symptom diaries, quality of life, between-visit events | ePRO tasks by phone link with reminders |
| Safety events | Adverse events and serious events with severity and causality | Adverse event form and SAE report form |
| Many countries, many clinics | Site coordinators, local numbering, by-site data views | Site coordinator portal and multi-site management |
| Regulatory-grade traceability | Who changed what, when and why | Field-level audit trail, edit checks, auto-queries, e-signatures |
| Handing data to partners | A dataset a sponsor or statistician can read | CSV or Excel with a data dictionary; CDISC SDTM export |
Questionnaire wording is yours to supply. Licensed instruments stay with your study documents.
Upload your protocol or describe the visits, let the AI study builder draft the schedule and forms for your review, and enter a few fake families end to end. Free sandbox, every feature, no credit card.
Governance
Families share very personal information, and they often do so because they trust the foundation. Good stewardship means being able to say where the data lives, who can see it and how it is protected. Capture is hosted in the EU (Frankfurt) or the USA (N. Virginia), data is encrypted at rest and in transit, and access is role-based with the database enforcing row-level security. Staff can turn on two-factor authentication with any authenticator app. These are product controls, not a certification; your own policies, data protection impact assessment and agreements with sites still apply.
The audit trail is written by the database itself, one row per changed field, and it cannot be edited through the interface. Clinical data is soft-deleted only. For a foundation that may one day hand its registry to a company or a regulator, this is the difference between a dataset and a defensible dataset. If the study is a drug or device trial rather than a registry, the foundation or its academic partner may be the sponsor and carry sponsor duties; our 21 CFR Part 11 compliant EDC page explains the shared responsibility and the rare disease clinical trials page covers trial-specific design.
Plan the data-sharing questions early. If the foundation intends to share data with researchers, build the consent so that it says so, and keep the export process documented. The data management plan template is a starting point for writing down who owns, cleans, locks and shares the data.
First 60 days
Define the visits, the questionnaires, who completes each and how often. Even a short registry needs a written data list.
Upload the document for an AI draft of visits and forms, or start from templates. Nothing is saved until a person reviews it.
In the sandbox, run consent, a caregiver diary and a clinic visit through edit checks and exports. Invite your clinicians to try the coordinator portal.
Export the blank eCRF PDF for the ethics or IRB submission and attach the consent text.
Approve the forms, which locks them for live use, then enrol the first family by QR code or invitation.
Before launch
Who is legally responsible for the study and for the personal data, in writing.
Every field linked to a question the study will answer; nothing collected just in case.
Who answers which questionnaire, and how assent is handled for children.
Coordinators have practised in the sandbox, not on live patients.
A sample dataset and dictionary opened by someone outside the study team.
Yes. A natural history study is built as a schedule of visits with eCRF forms for clinic data and ePRO tasks for questionnaires. The same platform can later run an interventional study with randomization if the design needs it.
Yes. Questionnaires open from a secure link in the phone browser with no app, so a parent can answer on the participant’s behalf. The consent flow supports Legally Authorized Representative signatures, and a pediatric assent template is available.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures, role-based access and edit checks. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
You can host in the EU (Frankfurt) or the USA (N. Virginia). Data is encrypted at rest and in transit.
Start the free sandbox. It has every feature, no credit card and no time limit. You pay only once you go live with real participants; see the pricing page for plans.
Keep exploring
EDC for rare disease clinical trials
Small-population trial design.
Natural history study software
Registry and observational design.
EDC for registry studies
Long-running patient registries.
Parent-proxy ePRO template
Caregiver-completed questionnaires.
QR code participant enrollment
Recruit without app installs.
Build the whole study in the free sandbox. No credit card, and you pay only when you go live with real participants.