Children are not small adults: dosing depends on size, consent involves parents and the child, and questionnaires must match age and ability. Capture calculates body surface area at entry, supports parental and witness signatures, and runs age-appropriate questionnaires for children and caregivers.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Weight
WEIGHTHeight
HEIGHTBody surface area (Mosteller)
BSABMI
BMIWhat matters in paediatric trials
Study design
ICH E11 describes age groups from preterm newborns to adolescents, and a single paediatric programme may span several of them. Each group can need different formulations, doses, sampling schedules and outcome measures. A trial enrolling children from 2 to 17 might use observer-reported outcomes for the youngest, a faces pain scale for young children and standard numeric scales for teenagers.
Building this into the study means age-based skip logic and forms that apply to the right participants, with the rule written once and applied the same way at every site. Record the child's age at each visit, because a child who crosses an age boundary during the study may need to switch versions. See the PedsQL template for age-specific versions.
Height and weight are safety data in children as well as dosing inputs. Record them at every visit with units, and derive growth percentiles or z-scores against reference charts in analysis.
| 2 to 4 | 5 to 7 | 8 to 12 | 13 to 17 | |
|---|---|---|---|---|
| Parent proxy quality of life | ||||
| Child self-report quality of life | ||||
| Observational pain scale | ||||
| Faces or numeric pain scale |
Dosing
Calculated fields show BSA (Mosteller and Du Bois), BMI and age from date of birth read-only during entry, so the site does not calculate by hand. Range checks on height and weight raise a query when a value falls outside the limits you set, catching unit errors before they reach a dose.
BMI (Body Mass Index)
Auto-derivedHeight (cm)
172
Weight (kg)
68.5
Result
23.2 kg/m²
Reference: WHO · shown read-only during data entry
Consent and assent
eConsent supports the participant's signature, a legally authorised representative signature for the parent or guardian, and an optional witness. The participant's signature is confirmed with a one-time email code, each signature is linked to the exact document signed, and the investigator countersigns with password re-authentication. Signed consent exports as a PDF with the audit trail.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Test calculated fields and parent signatures in the free sandbox.
Regulation
| Framework | Region | What it does |
|---|---|---|
| Pediatric Research Equity Act (PREA) | US | Requires paediatric assessments for certain applications, unless waived or deferred |
| Best Pharmaceuticals for Children Act (BPCA) | US | Incentives, including paediatric exclusivity, for studies requested by FDA |
| Paediatric Regulation and PIPs | EU | Requires an agreed Paediatric Investigation Plan for new medicines, with possible waivers or deferrals |
| ICH E11(R1) | International | Principles for clinical investigation of medicines in the paediatric population |
Families
Children go to school and parents work. Visits scheduled during school hours, long questionnaires in the clinic and frequent blood draws all make participation harder. Remote questionnaires completed at home, visit windows that allow flexibility, and sampling schedules designed around the blood volume limits help families stay in the study.
Record who completes each caregiver questionnaire and keep the same reporter where possible. See the parent proxy ePRO template and the Wong-Baker FACES and FLACC template for age-appropriate measures.
Study build
Forms and measures assigned by age with skip logic.
Parent permission, child assent and age of majority plan.
Height and weight with range checks; BSA calculated.
Sampling schedule within ethical limits.
Which caregiver completed each questionnaire.
PIP or PREA commitments reflected in the protocol.
An EU development plan for studying a medicine in children, agreed with EMA before certain applications can be made.
Parents or guardians give permission and, where able, the child gives assent. Both are documented according to local rules.
Yes. BSA (Mosteller and Du Bois), BMI and age from date of birth are calculated fields shown during entry.
Yes. Legally authorised representative signatures are supported, with an optional witness.
With skip logic based on age group, so each participant sees the right version.
Yes, in the free sandbox with every feature.
Keep exploring
Calculated dosing inputs, parent signatures, age-based forms. Free sandbox.