Young children cannot fill in questionnaires, so parents often answer for them. That works for what a parent can see, and less well for what only the child can feel. This template separates the two.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Caregiver diary
About your child today
How many times did your child wake during the night?
Did your child cough during the day?
Did your child miss nursery or school today?
Key points
Who should answer
Regulatory guidance on patient-focused drug development encourages collecting information from the patient whenever the patient can provide it, and from observers only for what they can actually observe. A parent can reliably report that their toddler woke three times, refused food or had a seizure. A parent cannot reliably report how nauseous their child felt. Questionnaires that ask parents to rate their child's feelings are proxy reports, and results are interpreted more cautiously.
The practical design rule is to phrase caregiver questions as observable events and behaviours, and to let children answer questions about feelings as soon as they are old enough. Many studies use age bands: caregiver-only below a threshold, child self-report plus caregiver report in a middle band, and child self-report above it.
Instruments such as the PedsQL have child self-report forms for different age ranges and matching parent-proxy forms. If you collect both, schedule both, and analyse them separately; they answer different questions.
| Under 5 | 5 to 7 | 8 and over | |
|---|---|---|---|
| Caregiver: observable events | |||
| Child: pictorial or faces scale | |||
| Child: standard self-report | |||
| Caregiver: proxy for feelings |
In Capture
Each assessment on the schedule records who completes it: the participant, a caregiver or site staff. Caregivers complete theirs on their own phone from a secure link, and the answers sit in the child's record, separate from the child's own reports.
Patient-reported
Participant, own phone
Observer-reported
Caregiver
Clinician-reported
Site staff, clinic tablet
Performance outcome
Site-run test, e.g. chair rise
Build it in the sandbox and complete it as a parent would.
In practice
Decide who the caregiver is and keep it consistent. If a mother completes the diary for the first month and a grandparent for the second, changes in scores may reflect the reporter, not the child. Record who completed each entry, and ask families to keep the same reporter wherever possible.
Keep burden realistic. Parents of children in paediatric trials, particularly in rare diseases, already carry a heavy care load. Short daily diaries with clear windows and a few well-chosen questions work better than long weekly questionnaires. And connect consent and assent to what the family will be asked to do: the pediatric assent template covers both the parent's permission and the child's agreement.
Interpretation
Research on paediatric quality of life consistently finds that parents and children agree more on observable domains, such as physical function and school attendance, than on internal ones, such as pain, worry and mood. Parents of children with chronic conditions also tend to rate their child's quality of life lower than the children rate it themselves.
Neither report is simply "right". Where both are collected, analyse them as separate perspectives, pre-specify which is primary, and avoid substituting a parent's answer for a missing child's answer in the same analysis. Recording who completed each questionnaire, as the child's own report or as proxy, is what makes that separation possible.
Before go-live
Who reports what at each age.
Caregiver items phrased as events and behaviours.
Which caregiver completed each entry.
Child and parent versions where both are used.
Minutes per day for families.
Age-appropriate assent alongside parent permission.
Only if the protocol allows it and the parent version of the instrument is used. Record who completed it so proxy and self-reports stay separate.
No. Analyse them as separate perspectives, with one pre-specified as primary.
A questionnaire where a parent answers on behalf of a child, including about the child's feelings. Regulators interpret proxy reports of feelings cautiously.
An assessment where a caregiver reports observable events or behaviours, such as coughing or waking at night.
Often from around 8 years with standard questionnaires, and younger with pictorial scales. The protocol should define age bands.
Yes. Assessments can be set to be completed by a caregiver on their own phone.
Yes, in the free sandbox.
Keep exploring
Caregiver and child forms in one study. Free sandbox.