Thousands of healthy people, one injection day, a symptom diary afterwards and months of watching for cases. Capture gives each vaccination point its own site, a dose and lot record and a phone diary for solicited reactions. Build free, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Day 0 | Days 1-7 | Day 28 | Month 6 | Surveillance |
|---|---|---|---|---|---|
| Consent and eligibility | |||||
| Dose, lot number and site of injection | |||||
| Solicited reaction diary | D | ||||
| Blood sample for antibody testing | |||||
| Unsolicited and serious events | |||||
| Suspected case report |
x = done at this visit, D = daily diary on the phone. Demo schedule only.
What a vaccine field trial needs from its data collection
Field and community logistics
A vaccine field trial is mostly a logistics exercise on the days people are enrolled. The data model has to match the queue. In Capture each vaccination point can be a site, with a site-specific QR code for enrolment that works from the phone browser with no app to install, site-level participant numbering (for example 012-0431) and a site coordinator portal for the staff on the day. PII segregation lets the person at the desk see names while the research team works from coded IDs. For the mechanics, see QR code participant enrolment and multi-site trial management.
Connectivity is a real constraint. Capture does not claim an offline mode, so plan for places with poor signal: a paper source sheet for the day with entry the same or next day, a nearby spot with reception, or a team member holding the data entry role. Decide in advance which fields are source on paper and which are entered directly, and write that into the data management plan.
The dose record is the one form that cannot be vague. Capture the product or arm label, lot number, expiry date where the protocol requires it, injection site and side, time of administration and who administered. Blinded studies need care: the person who prepares or labels the product may know the allocation while assessors and participants do not. Capture's blinded roles never receive treatment-arm values, enforced by masked database views and row-level security, and randomization can sit in the same study; see blinded and unblinded role management. Cold-chain monitoring and pharmacy stock are separate systems, and Capture does not claim to integrate with them.
Solicited reactions are the local and general symptoms the protocol asks about by name (pain at the injection site, redness, swelling, fever, fatigue, headache), usually for a short fixed window after each dose and graded on a scale the protocol specifies. FDA has published a nonbinding toxicity grading scale for healthy adult and adolescent volunteers in preventive vaccine trials; whether a study uses it or another scale is a protocol decision, so check current guidance. Build the diary as a short ePRO form delivered by secure link on the phone, with reminders, and keep it distinct from the adverse event form used for unsolicited events and serious events.
A rule that sends a participant to a separate adverse event form when a reaction passes a threshold should be treated as workflow, not as medical advice. Edit checks raise queries on data, they are not clinical alerts, so the protocol must say how a participant with a severe reaction reaches a clinician.
Reaction diary, day 2 (demo study)
Participant 012-0431 · Dose 1
Pain at injection site
PAINRedness diameter
REDMMFever measured today
FEVERMedicine taken for symptoms
MEDTAKENPrompts medication name
Data streams
| Stream | What is captured | Where it lives in Capture |
|---|---|---|
| Enrolment and dosing | Consent, eligibility, product, lot, injection details | eConsent plus an eCRF dose form per dose |
| Reactogenicity | Solicited local and general reactions, daily for the protocol window | ePRO diary on the participant's phone, with reminders |
| Safety | Unsolicited events, serious events, events of special interest | Adverse event form with seriousness and sign-off |
| Immunogenicity and cases | Sample IDs and dates, antibody result fields, suspected case reports | Repeating rows and surveillance forms, exported by site |
Laboratory results are entered or loaded by your team; Capture does not claim a laboratory integration.
Generate a QR code for a mock vaccination point, enrol a few test participants and fill in the reaction diary from a phone. Free sandbox, no credit card.
Efficacy and special designs
Efficacy trials wait for cases. The primary endpoint is usually a laboratory-confirmed infection, so the surveillance form must capture symptom onset date, test date, test type and result, and an adjudication field if an independent committee classifies cases. Keep the date of onset separate from the date of report, since the gap shows how well surveillance works. If cases occur mostly outside your study sites, decide early how participants report symptoms (for example a phone form that anyone can open from a secure link) and who follows up.
Some trials randomise communities or contacts rather than individuals, for example vaccinating a ring of contacts around a case. That is a cluster design; the group-level setup is covered in EDC for cluster-randomised trials. Sites become clusters with their own numbering and filters, and the statistician supplies the allocation schedule.
Many vaccines are tested in children and adolescents. Parental permission and the child's own agreement are separate steps; Capture has a pediatric assent consent template and a caregiver-completed form option for diaries a parent completes. Local rules on who can consent for a minor vary, so use the ethics committee's guidance rather than assuming. For children generally, see EDC for pediatric clinical trials.
Build sequence
Create each clinic, school or community point as a site, generate its QR code and assign day staff.
Upload the protocol (PDF, DOCX or DOC) for the AI study builder to propose visits and forms, then review every form.
Add product, lot, injection site, time and administrator, with a deviation field for anything off protocol.
Create the short daily ePRO form for the protocol window, set reminders and keep it apart from the adverse event form.
Add case report and sample tracking forms, and the adverse event and serious event forms with sign-off.
Log in as an assessor to confirm allocation is hidden, rehearse the injection day, approve the forms and go live.
Before the first dose
Product, lot, expiry, site, side, time and administrator fields match the protocol and the pharmacy log.
Length, symptoms and the scale named in the protocol, with a clear route to a clinician for a severe reaction.
A paper fallback and a rule for when entry happens at sites with weak signal.
Onset, test and adjudication fields match the endpoint definition.
Assessor and participant views checked in the sandbox.
CSV or Excel with data dictionary, by site, opened in the statistics package.
Yes. Capture supports site-specific or study-specific QR-code enrolment from the phone browser with no app install, plus site-level participant numbering.
No offline mode is claimed. Plan a paper fallback and entry once signal is available, and write the plan into the data management plan.
Yes. Build a short ePRO form delivered by secure link on the participant's phone with reminders, separate from the adverse event form used for unsolicited and serious events.
Yes, as fields on a dose form, with a repeating row or separate form for each dose. Each change keeps a field-level audit trail with the reason.
No integration is claimed. Stock and temperature records stay in their own systems; Capture holds the participant-level dose record.
Yes, with parental consent through eConsent and an assent step using the pediatric assent template, subject to your ethics committee. Caregivers can complete diaries on a child's behalf.
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants. Pricing is not published on the site, so ask for terms for your study.
Keep exploring
QR code participant enrolment
Enrol at the vaccination point.
Adverse event template
Seriousness, severity, relationship, sign-off.
EDC for cluster-randomised trials
Ring and community designs.
Blinded and unblinded roles
Keep allocation hidden from assessors.
EDC for pediatric clinical trials
Consent, assent and caregiver forms.
Patient diary software
Phone diaries with reminders.
ePRO
Questionnaires on the participant's phone.
Pricing
Free sandbox, pay at go-live.
Free sandbox with every feature. No credit card, and you pay only when you go live.