ADHD studies mix clinician-rated scales, parent and teacher observations, assent from children and safety measurements such as blood pressure, pulse and growth. Capture holds them in one study with one audit trail. Build and test the protocol in the free sandbox, no credit card, and pay only when you go live.
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| Assessment | Screen | Baseline | Wk 1 | Wk 2 | Wk 4 | Wk 6 |
|---|---|---|---|---|---|---|
| ADHD rating scale (clinician) | ||||||
| Global impression (severity / improvement) | ||||||
| Vitals: BP, pulse, weight, height | ||||||
| Parent diary (phone) | D | D | D | D | D | |
| Suicidality screen | ||||||
| Adverse events and sleep/appetite |
x = visit form, D = caregiver diary entries
What an ADHD trial needs from its EDC
The study data
The primary endpoint in most ADHD drug trials is the change from baseline in a clinician-administered symptom rating scale. The ADHD Rating Scale (ADHD-RS-5) is the best-known example: it is built on the DSM-5 symptom criteria, has 18 items scored 0 to 3 for a total of 0 to 54, and comes in home and school versions. Clinical Global Impression severity and improvement ratings usually sit alongside it as secondary endpoints, and some programmes add other parent, teacher or self-report measures and executive function scales. Analog classroom and laboratory designs add timed performance tasks measured at several time points across the day.
The risk to data quality is mostly about who said what and when. A score based on a parent interview is not the same as one based on a teacher form, and the recall period is usually the past week. If the informant is not recorded, or a visit lands outside its window, the comparison across visits gets weaker without anyone noticing. In Capture each scale is a site eCRF form with typed fields per item, and each entry is attributed to the user who made it, with the old value, new value and reason for any change in the audit trail. Add a field for informant and, where the protocol requires it, a visit window around each scheduled week.
ADHD programmes also have particular regulatory shape. Because the disorder starts in childhood, regulators expect paediatric data for a drug intended to treat it; FDA's draft guidance on stimulant development discusses adequate and well-controlled paediatric studies, including a placebo-controlled parallel study in the youngest age band for new molecular entities. That means many sponsors run adolescent, child and adult cohorts with different assessments. The wider paediatric picture is covered in EDC for paediatric clinical trials; this page goes narrower, on the data ADHD protocols specifically carry.
A clinician-rated scale and a global impression belong on site eCRF forms completed at the visit; see the CGI template for the structure of a global rating form. A caregiver diary or questionnaire can be set up to be completed by the parent on their own phone, in the same study as the child's own forms. The parent proxy ePRO template explains when to ask a parent for what they can observe and when to ask the child. If a teacher version is part of your protocol, decide in the data management plan how it is collected and entered, for example as a returned form transcribed to a site eCRF form by named staff, and record the source in the field. For how the categories differ, see clinician-rated and patient-reported outcomes.
Rating summary
Informant
INFORMInattention subscale
INATTHyperactivity-impulsivity subscale
HYPIMPTotal score
TOTALDerived from the item scores, read-only
23 CalculatedWeight
WEIGHTDown 1.9 kg from baseline: confirm
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Primary symptom scale | 18 item scores, subscale and total, by informant | Site eCRF form per visit with calculated totals; informant field |
| Global impression | Severity at baseline, improvement after | CGI template |
| Parent-observed behaviour | Daily or weekly caregiver diary | Caregiver-completed ePRO on the parent's phone; see parent proxy ePRO |
| Cardiovascular and growth safety | BP, pulse, weight, height at every visit | Vital signs template with range edit checks; BMI calculated |
| Sleep and appetite | Reported change from baseline | Sleep diary or a short visit form |
| Suicidality screen | Prospective assessment where the protocol requires it | C-SSRS template; site eCRF form |
| Consent and assent | Parent permission and child assent, signed and countersigned | Paediatric assent consent template in eConsent |
| Adverse events | Onset, severity, seriousness, relationship | Adverse event form |
Scale wording is yours to supply. 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.
Assent and safety
Children cannot give legal consent, so paediatric studies combine permission from a parent or guardian with the child's own assent, scaled to age and maturity. Capture's eConsent supports the participant signature with an email one-time code, an optional witness and a Legally Authorized Representative signature, and a document is fully executed only after the investigator countersigns. A paediatric assent template is available to start from. Your ethics committee decides the ages and wording, so treat the template as a starting layout rather than approved text. See eConsent software for clinical trials and legally authorized representative consent for how the signatures work.
Cardiovascular safety is the most data-heavy part of a stimulant programme. Blood pressure and pulse at each visit are compared with baseline, and in children are often judged against age, sex and height percentiles rather than a fixed cut-off. Capture can calculate values such as BMI and show them read-only, and edit checks can raise an automatic query when a value breaks a range or rule you set. For paediatric blood pressure you will need to build the percentile rule or reference table from your own source; the system enforces the rule you define, it does not ship a paediatric norm table. Weight and height at each visit let growth be reviewed in the same way.
ADHD programmes often assess suicidal ideation prospectively, particularly for non-stimulants, and monitor sleep, appetite and mood. Record these as visit forms so a missed assessment shows as an open item. Be clear in your protocol that an edit check is a data-management prompt that makes a signal visible, not a clinical alerting system. The investigator's safety procedures remain in the protocol. For adverse events, the adverse event reporting workflow covers seriousness and sign-off.
Build sequence
A practical order of work for a sponsor or investigator team.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the visit schedule and forms. Nothing is saved until a person reviews it.
Many programmes have screening, washout or titration, double-blind treatment and an extension. Build each as an epoch with its own visit plan.
Range rules on vitals and weight, derived totals on scales, and allowed windows around each scheduled week.
Create the parent diary with reminders and a completion window. Parents answer through a secure link on their own phone, with no app to install.
Enter practice participants through the full schedule, trigger every check, and show the principal investigator the working build.
Forms move from draft to approved and approved forms lock for live use. Real participants start the paid live phase.
Design variants
Different designs stress different parts of the build. A paediatric fixed-dose or dose-optimisation study leans on caregiver reporting and growth data. An adolescent study adds self-report and more attention to assent. An adult study uses self-report and investigator-rated scales and drops the parent entirely. Capture lets one study hold more than one arm or cohort with different forms, so a programme with a child and an adult stratum does not need two databases.
Digital therapeutics and device-based ADHD programmes add a further layer: usage and engagement data, and sometimes performance measures from the product itself. Capture does not claim a device integration for these beyond the native wearable sync described in EDC for wearable device studies. If your product exports data, plan how it will be loaded and reconciled with the visit data, and keep the clinician-rated endpoints in the EDC as the controlled record.
Multi-site recruitment is the norm. QR-code enrolment, site-level participant numbering and a separate site coordinator portal keep sites organised, and PII segregation means site coordinators see participant names while researchers see coded IDs. See multi-site clinical trial management and, for registrational programmes, Phase 3 EDC.
Before first participant
Rating scales and questionnaires licensed through their rights holders, with terms filed in the study documents.
Who answers which version, and how teacher forms are collected and entered.
Parent permission and age-banded assent wording approved by the ethics committee.
Percentile or threshold logic for blood pressure and pulse in the edit checks.
Allowed ranges match the recall period of each scale.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. A clinician-rated scale is built as a site eCRF form with one typed field per item and calculated subscale and total scores. The licence for any published scale stays with your study documents; Capture does not supply instrument wording or verify licences.
Yes. An assessment can be set to be completed by a caregiver. It opens from a secure link in the phone browser, with reminders and a completion window you control, and no app to install.
Through eConsent. A paediatric assent template is available to start from, and the signature, optional witness and Legally Authorized Representative support are part of the flow. Your ethics committee decides the wording and age bands.
Yes. Vital signs and anthropometrics are visit forms with range edit checks and calculated fields such as BMI. Paediatric percentile logic must be built from your own reference source.
Teacher forms can be transcribed to a site eCRF form by named staff, with the informant recorded in a field. The platform supports caregiver respondents; define the teacher process in your data management plan.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, and multi-site work uses site-level numbering, a site coordinator portal and by-site exports.
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.