The school is the cluster, the teacher delivers the programme, a parent gives permission and the child agrees. Capture handles consent for minors, school-level sites and pupil outcome forms with coded IDs. Build free, no credit card.
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| Teacher | Research assistant | Parent | Statistician | |
|---|---|---|---|---|
| Pupil name and class list | ||||
| Pupil outcome scores (coded ID) | ||||
| Permission and assent status | ||||
| Intervention delivery log | ||||
| School allocation (programme or control) |
What a school-based trial needs from its data collection
The setting
School trials tend to be cluster randomised: a school, a year group or a class receives the programme and another does not, because the intervention is delivered to a group and contamination between neighbouring pupils would dilute the effect. The consequences for data are concrete. Each school needs its own identity in the dataset, participant numbers need to carry the school (Capture supports site-level numbering such as 007-0112), and exports must be filterable by school so the statistician can model clustering. The design side is covered in EDC for cluster-randomised trials; this page is about running one inside schools.
The people collecting data are teachers, school nurses and research assistants, not clinical research coordinators. Each school can be a site with a site coordinator role for the person who manages class lists and a data entry role for the person who records scores. Role-based access and PII segregation let staff who handle the class list see names while researchers and analysts work from coded IDs, and blinded roles never receive allocation values, enforced by masked database views and row-level security. Randomization can sit in the same study; see randomization in EDC. The clinical-trial pages for children in a medical setting are in EDC for pediatric clinical trials.
Do not assume forms and consent are available in other languages. Capture does not claim multilingual support, so for schools where families use another language, plan translated paper information sheets approved by your ethics committee, with the recorded consent decision entered by staff.
For minors, ethics committees generally expect permission from a parent or guardian and, as the child is able, the child's own agreement (assent). The age at which assent applies, whether written assent is needed and whether an opt-out route is acceptable for low-risk school programmes all vary by country and committee, so take the rules from your ethics approval. Capture provides eConsent with on-screen signature, email OTP confirmation, investigator countersignature and optional witness or legally authorised representative signature, plus a pediatric assent consent template you can adapt. Parents sign from a secure link on their own phone; the assent step can be recorded separately so the audit trail shows both decisions and their dates.
Where consent is collected on paper through school bags, record the outcome on a consent-status form with the date it was received, and file the signed paper in the investigator site file. Data protection rules for children also apply: under GDPR the age at which a child can consent to an online service differs between EU member states, and in the US education-record rules such as FERPA may apply to school data. Ask your data protection officer, and do not treat this page as legal advice.
Where this fits
| Question | This page | Neighbouring page |
|---|---|---|
| Where is the study run? | In schools, with teachers and school staff | Pediatric trials run in clinics and hospitals |
| What is the cluster? | A school, year group or class | Cluster design page for hospital wards, practices and villages |
| What are the outcomes? | Behaviour, activity, mental wellbeing, BMI, learning measures | Childhood obesity trials for the clinical condition |
| Who consents? | Parent permission plus child assent, sometimes opt-out | Legally authorised representative consent for adults who cannot consent |
| Who holds identity data? | School staff see names, researchers see coded IDs | PII segregation explained |
Create two schools as sites, enrol test pupils with coded IDs and try the permission and assent forms. Free sandbox, no credit card.
Delivery and outcomes
Fidelity matters in a programme trial because a lesson that was never taught cannot have worked. Build a short delivery log per class: week, session number, whether it ran, how many pupils attended, minutes delivered and a reason if it was cancelled. Teachers are busy, so keep it to a handful of fields and enter it as a repeating row so a twelve-week programme is twelve rows, each with its own audit trail. A field that asks the teacher what they changed from the manual gives a fidelity measure without an observer.
Pupil outcomes can be questionnaires, physical measures or tests. Questionnaires open from a secure link in a phone or tablet browser, with reminders, and younger children may need an adult to read items aloud or complete a proxy version; see the parent-proxy ePRO template. Measures like height and weight go into eCRF forms completed by a trained assistant, with calculated fields such as BMI shown read-only during entry. Where an outcome uses a copyrighted scale, the licence stays with the study documents, and Capture does not supply the instrument or check the licence.
School records such as attendance, grades or exclusions are sometimes outcomes. Capture does not claim a link to school information systems, so agree with the school how records are provided and who enters them, record the source on the form, and check whether your ethics approval and the school's data agreement allow it. Because pupils move school or leave, plan a withdrawal and loss-to-follow-up form so the dataset shows why someone has missing data.
Build sequence
Add each school, its coordinator and data entry staff, and agree who sees names.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
Set up parental permission through eConsent and a separate assent record, or a paper-status form, as your ethics committee approved.
Add the class delivery log, pupil questionnaires and measurement forms, with edit checks on ranges and dates.
Log in with each role in the sandbox and confirm who sees names, scores and allocation.
Approved forms lock for live use. Real pupils start the paid live phase.
Before the first school
Whether permission is opt-in or opt-out, and whether assent is written, set by the approving committee.
What the school shares, what researchers hold and who may see names.
Teacher, research assistant and statistician views checked in the sandbox.
A handful of fields a teacher can complete in under a minute.
Translated information sheets handled on paper; no multilingual forms assumed.
CSV or Excel with the data dictionary, filtered by site, opened in the statistics package.
Yes. Use eConsent for the parent's signature and record the child's assent as a separate step or form, with dates in the audit trail. The pediatric assent template is a starting point; your ethics committee sets the rules.
Yes. Capture supports multiple sites with site-level participant numbering, a site coordinator portal and by-site filtering and exports, which suits cluster analysis.
Only if you give them that access. Roles control visibility, and PII segregation keeps names apart from outcome data so researchers can work from coded IDs.
No multilingual support is claimed. Plan translated paper material approved by your ethics committee and enter the decisions in Capture.
No integration is claimed. Agree how attendance or grade data reach the study and have a named person enter them, with the source recorded.
Yes, but most school programmes randomise at school or class level. Set up the allocation your statistician specifies; Capture supports randomization in the same study.
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
EDC for cluster-randomised trials
Group-level allocation and analysis.
EDC for pediatric clinical trials
Children in clinical settings.
Pediatric assent template
A starting point for child assent.
Parent-proxy ePRO template
Questionnaires completed by a parent.
Childhood obesity trials
School programmes for weight outcomes.
eConsent
Signed on the parent's phone.
For academia
University research teams.
Pricing
Free sandbox, pay at go-live.
Free sandbox with every feature. No credit card, and you pay only when you go live.