Childhood cancer trials dose by body size, consent through parents and assent from the child, run in few centres and need follow-up that lasts decades. Capture keeps the dosing, response and event dates, safety and consent in one study with one audit trail. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Size and dose
Height
HEIGHTWeight
WEIGHTBody surface area (Mosteller)
BSACalculated from height and weight
0.78 m² CalculatedPlanned dose
DOSEPLANDose given
EXDOSEDose modification
EXADJWhat a pediatric oncology trial needs from its EDC
The study data
Pediatric oncology is a field of rare diseases treated in organised cooperative groups. Many trials are staged by risk group, give multi-agent chemotherapy in phases, and measure event-free survival: the time from enrolment to relapse, progression, second malignancy or death. Registered legacy trials from cooperative groups report outcomes this way (for example ten-year event-free and overall survival in Hodgkin lymphoma trials). Early-phase studies of new agents in children are smaller and focus on dose, tolerability and early signs of activity. The data model follows from this: a risk-group assignment, a phase-by-phase treatment record, dated events and a very long follow-up tail.
Dosing is where children differ most from adults. Chemotherapy is commonly dosed per square metre of body surface area, and in infants and small children some drugs are dosed per kilogram instead. Capture calculates body surface area (Mosteller and Du Bois are both available) from height and weight and shows it read-only, so the site can compare the dose given with the planned dose. Because children grow during therapy, recompute size at every cycle. The dose rule itself, such as rounding or weight thresholds, comes from the protocol, and the EDC records what was ordered, given, reduced or held, and why.
Performance status needs an age-appropriate scale. Adult scales such as ECOG and Karnofsky are widely used, and protocols commonly pair a Karnofsky-type score for older participants with a play-performance equivalent for younger children. Which one applies at which age is for the protocol to state. The related paediatric pain scale template shows how an observer-rated or faces-based scale sits in a form.
An event-free survival analysis needs a defensible date for each event. Record the date of the scan, marrow or biopsy that documented relapse or progression, the site of first event, the date of any second malignancy and the date of death. Add date logic so that no event can precede enrolment, and a death cannot precede the last recorded visit. Date last known alive is the field that most often decays; build a short annual follow-up form so a lapse in contact is visible while there is still time to trace the family.
weeks
Risk group assigned
Cycles with weekly labs
Response assessment
Event surveillance
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and staging | Diagnosis, histology, stage, risk group, prior therapy, organ function | Eligibility form with edit checks and skip logic |
| Consent and assent | Parent permission, child assent, witness or LAR where needed | Paediatric assent template in eConsent |
| Dosing | Height, weight, BSA, planned and given dose, reductions, delays | Repeating cycle form; BSA calculated read-only |
| Laboratory monitoring | Counts, chemistry, units, local reference ranges | Laboratory form with range checks |
| Response and events | Imaging or marrow date, response, relapse, second malignancy, death | Visit and follow-up forms with date edit checks |
| Adverse events | CTCAE term, grade, seriousness, relationship, action | Adverse event form and SAE report form |
| Symptoms and quality of life | Child self-report or parent proxy symptom and function data | Oncology side-effect diary and PedsQL structures |
Capture records the data your protocol defines. Risk assignment, response and toxicity grading are decided by clinicians.
Upload the protocol, let the AI draft the visits and forms for review, then enter a practice child’s height and weight over two cycles and check dose edit checks. Free sandbox.
Safety reporting
Intensive paediatric regimens commonly cause cytopenias, infections, mucositis and organ toxicity, so the adverse event form has to carry more than a term and a grade. Record CTCAE grade on the 1 to 5 scale, seriousness, relationship to each protocol drug, the action taken and supportive care. Keep severity, seriousness and causality as separate answers. The CTCAE grade lookup helps sites and data managers check a term against the published criteria, and the investigator assigns the grade. The AE seriousness decision tree covers the serious split.
Serious events follow the SAE report form. Reporting clocks depend on your regulator and sponsor, and the SAE reporting deadline calculator is a planning aid, not an authority. For safety signals that cross centres, the SUSAR reporting page explains the workflow. Dose changes follow lab values, so a range-based edit check can raise a query when a day-1 count is below a protocol start threshold but a full dose is recorded.
Children report symptoms differently from adults. Younger children may need a parent or nurse to report, and older children can often answer themselves. Build the questionnaire in both forms, and capture who answered. The parent-proxy ePRO template shows the pattern, and the questionnaire opens from a link on a phone, with no app install.
Cannot submit yet
Causality is required because the event is serious.
Build sequence
A realistic order of work for a cooperative-group site network or an investigator-led study.
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.
Screening form with risk group and organ function checks, and a cycle form with height, weight, calculated BSA, planned and given dose.
Response assessments, dated events and an annual follow-up form with last contact date.
Parent permission and age-appropriate assent documents, tested on a phone.
Run practice children through a dose reduction, a relapse and a death, check the exports, approve the forms and start the paid live phase when real participants enrol.
Consent, sites and follow-up
Consent is a conversation with parents at a frightening time, so the paperwork should not add friction. Capture’s eConsent supports an on-screen signature after an email one-time code, an optional witness, a Legally Authorized Representative signature and investigator countersignature, and the signed document exports as a PDF with the audit trail. The consent route and assent age bands are decided by your ethics committee. See eConsent for clinical trials, legally authorized representative consent and EDC for paediatric trials.
Rare tumours mean few participants per centre and many centres. Capture supports QR-code enrolment, site-level participant numbering, a site coordinator portal and by-site exports; see multi-site clinical trial management. Source data verification can be set per field, so monitors concentrate on eligibility, dosing and event dates (risk-based monitoring and SDV). Cooperative-group long-term follow-up studies enrol patients with consent from the patient and/or the parent or guardian, and the same pattern of a separate follow-up form and consent applies if your protocol feeds a survivorship cohort.
Exports come as CSV or Excel with an automatic data dictionary, and CDISC SDTM export gives SAS XPT datasets with Define-XML (SDTM export). For adult tumour types and the wider picture, see EDC for oncology clinical trials. For survival endpoints, the survival sample size calculator gives a first estimate.
Before first participant
BSA or weight basis, rounding, thresholds and what counts as a dose modification.
What counts as relapse, progression and second malignancy, and which date is used.
Which scale applies to which age band, and who completes it.
Parent permission, assent bands and wording approved by the ethics committee.
Annual contact form, tracing steps and end of data collection.
Wide CSV with data dictionary opened in the statistics package.
Yes. Body surface area (Mosteller and Du Bois) is calculated from height and weight and shown read-only. The dose rule and rounding come from your protocol.
As separate date fields for enrolment, documented relapse or progression, second malignancy, death and last contact, with edit checks for impossible sequences. The analysis runs in your statistics package.
eConsent supports an on-screen signature after an email code, an optional witness, a Legally Authorized Representative signature and investigator countersignature, with a paediatric assent template to start from. Your ethics committee sets ages and wording.
Yes. Build a follow-up form for late effects, second tumours and last contact, scheduled annually. Contact tracing itself is a study procedure.
Yes. Capture is used from Phase 1 through Phase 3, and forms and schedule are built from your protocol.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
EDC for oncology clinical trials
Oncology building blocks across tumour types.
EDC for paediatric clinical trials
Assent, proxy reporting and growth-sensitive safety.
CTCAE grade lookup
Grade criteria for common adverse event terms.
Paediatric assent template
A starting layout for child assent.
Capture eConsent
Remote consent with countersignature and audit trail.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.