Autism trials rely on what caregivers observe, what clinicians rate and what a participant who may not be able to consent alone can safely take part in. Capture keeps all three in one study with one audit trail. Test the whole protocol in the free sandbox, no credit card.
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| Caregiver | Clinician | Participant | |
|---|---|---|---|
| Irritability and behaviour checklist | |||
| Social responsiveness measure | |||
| Adaptive behaviour interview | |||
| Global impression (severity, improvement) | |||
| Adverse events and weight |
What an autism trial needs from its EDC
The study data
There is no single biological marker of autism, so trial endpoints are behavioural. For irritability, the Aberrant Behavior Checklist (ABC) irritability subscale, 15 items scored from 0 to 3, is a frequent primary outcome in registered trials, completed by a caregiver. Social communication is often measured by the Social Responsiveness Scale (SRS-2), which asks a parent or teacher to rate observed behaviour. Adaptive functioning is measured by the Vineland Adaptive Behavior Scales through a structured caregiver interview. A Clinical Global Impression of severity and improvement from the investigator is the usual anchor, and some programmes add repetitive behaviour scales, sleep and anxiety measures. The ADOS-2 is an observational assessment used mainly to confirm diagnosis and characterise the sample; it is rarely the outcome.
This structure makes respondent design the central data-capture question. A caregiver rating changes if a different person answers at the next visit, and a teacher rating differs from a parent rating of the same child. In Capture an assessment can be set to be completed by a caregiver on their own phone, in the same study as the participant's other forms, and a respondent field records who answered and their relationship. Where a trained interviewer scores the Vineland-style interview, that is a site eCRF form with named staff attribution in the audit trail. Interviewer-administered instruments are normally licensed, so keep rights-holder terms in your study documents; Capture does not supply instrument wording or verify licences.
Autism studies span children, adolescents and adults, often with co-occurring conditions and varying language and cognitive ability. That affects feasibility: a participant may not be able to complete a self-report, so the protocol has to say, for each instrument, who answers when the participant cannot. The more of that you write into the build, the less ends up as a protocol deviation. The wider paediatric considerations are in EDC for paediatric clinical trials, and the neurodevelopmental neighbours are in EDC for ADHD clinical trials.
Regulatory thinking on patient-focused outcomes separates what a person reports about themselves, what an observer reports about visible behaviour, and what a proxy reports about feelings they cannot see. Most autism endpoints are observer-reported by design. The parent proxy ePRO template explains the distinction and how to phrase caregiver items, and the glossary entry on clinician and observer outcomes defines the categories for your statistical analysis plan.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Diagnosis and eligibility | Diagnostic confirmation, age, severity threshold | Eligibility screening template with edit checks |
| Irritability or behaviour checklist | Item scores by caregiver, subscale total | Caregiver-completed ePRO with reminders; respondent field |
| Social responsiveness | Parent or teacher ratings at baseline and follow-up | ePRO task or a site form transcribed by named staff |
| Adaptive behaviour interview | Domain scores from a structured interview | Site eCRF form per visit |
| Global impression | Severity, then improvement from baseline | CGI template |
| Sleep and behaviour between visits | Caregiver diary | Sleep diary set for caregiver completion |
| Consent and assent | Representative signature, child assent | Paediatric assent template; LAR consent |
| Safety | Weight, metabolic labs, movement-related events | Vital signs, laboratory and adverse event forms |
Licensed instruments stay with your study documents. Capture does not supply or verify instrument licences, and licence controls exist only on participant questionnaires.
Upload the protocol, let the AI draft visits and forms for you to review, and test with sample data. Free sandbox, no credit card.
Consent and safety
For participants who cannot consent for themselves, a legally authorised representative signs. Capture's eConsent supports Legally Authorized Representative signature, an optional witness and investigator countersignature, with each signature linked by hash to the exact document content at signing time. Who counts as a valid representative, and when a participant's own assent is required, depends on the jurisdiction and the ethics committee, so write the rules into the protocol and use the system to record them. For adolescents and adults with capacity, the participant signs for themselves. The LAR consent page covers the flow, and impartial witness eConsent covers witnessing.
Safety design depends on the study drug. Antipsychotic programmes track weight, BMI, fasting glucose and lipids, prolactin where relevant and movement-related adverse events, so those need forms with ranges and calculated fields. BMI is calculated read-only, and edit checks raise an automatic query when a value breaks a range you set. For children, growth is judged against age and sex norms, which you must supply from your own reference source. Non-pharmacological and digital interventions have a different profile and may need only adverse event capture and engagement data.
Because caregivers report much of the safety information too, record the source of each adverse event: observed by the investigator, reported by the caregiver, or found on a form. Role-based access and PII segregation also help in studies with sensitive family information: site coordinators see participant names, researchers see coded IDs. See adverse event reporting software for the serious adverse event workflow.
Build sequence
A practical order of work for a sponsor or investigator team.
List every instrument, its respondent, and the fallback when the participant cannot answer. Put it in the data management plan.
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 the checklist as a caregiver-completed assessment with reminders and a completion window. The link opens in the phone browser.
Range rules on weight and labs, derived totals on scales, and windows around each scheduled visit.
Run practice participants through the full schedule, including a representative signing consent, and read the audit trail.
Approved forms lock for live use. Real participants start the paid live phase.
Before first participant
Caregiver, teacher, clinician and participant roles per instrument.
Rights-holder terms filed in the study documents.
Representative, assent and capacity rules approved by the ethics committee.
Who scores the interview and global impression, and how raters stay consistent.
Windows match the recall period of each measure.
CSV or Excel with the data dictionary checked in the statistics package.
Yes. An assessment can be set to be completed by a caregiver on their own phone through a secure link, with reminders and a completion window. Add a respondent field to record who answered.
Yes, as a site eCRF form completed by trained staff, attributed in the audit trail. The licence for the instrument stays with your study documents.
eConsent supports Legally Authorized Representative signature, an optional witness and investigator countersignature. Your protocol and ethics committee define who may sign and when assent is needed.
Capture does not prescribe outcomes. ADOS-2 is typically used to confirm diagnosis and characterise the sample, and you can build it as a site form for that purpose.
Yes. Vital signs and laboratory forms with range edit checks and calculated fields such as BMI cover the usual antipsychotic monitoring. Age and sex norms must come from your own reference.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with site-level numbering, a site coordinator portal and by-site exports for multi-site work.
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.
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Free sandbox with every feature. No credit card, and you pay only when you go live.