Psoriasis trials score the skin region by region, add a global assessment and ask the participant about quality of life, all against fixed week-16 style time points. Capture builds the PASI form with calculated totals next to the rest of the schedule. Test it in the free sandbox, no credit card.
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| Assessment | Screen | Baseline | Wk 4 | Wk 8 | Wk 16 | Wk 28 |
|---|---|---|---|---|---|---|
| PASI (head, trunk, arms, legs) | ||||||
| Static global assessment | ||||||
| Body surface area affected | ||||||
| Quality-of-life questionnaire (phone) | ||||||
| Laboratory and infection screen | ||||||
| Photographs |
x = form completed at the visit
What a psoriasis trial needs from its EDC
The study data
The registered phase 3 protocols for moderate to severe plaque psoriasis follow a recognisable pattern. The co-primary endpoints at week 16 are commonly the proportion of participants reaching PASI 75 and the proportion with a static Physician Global Assessment (sPGA) score of 0 or 1, meaning clear or almost clear, often with at least a 2-point improvement from baseline. PASI 90 and PASI 100, and sPGA 0, are typical key secondary endpoints, and some programmes make PASI 90 a co-primary. Body surface area, itch or pain numeric ratings and the DLQI follow as secondary or exploratory measures. Maintenance and withdrawal phases then run to week 28, 52 or beyond.
PASI is the data-quality trap. The score is built from four body regions, each with an area score and three severity ratings for erythema, induration and scaling, combined with region weights into a single index. Errors come from arithmetic, from a different rater at the next visit, and from baseline values being mistyped, which silently changes every responder calculation afterwards. In Capture the PASI form carries typed fields for each region, the regional and total scores are calculated and shown read-only, and each entry is attributed to the user who made it, with a reason recorded for any later change. An existing PASI eCRF template shows the structure to start from, and the rater should be a named field on the form.
Rater consistency matters as much as arithmetic. Because PASI and sPGA are investigator judgements, many programmes train raters and keep the same assessor for a participant across visits. A rater field on every form, and a by-site view of scores, makes drift easier to spot. If photographs are taken at set visits, record the date, region and a file reference in the form, and keep the images in the system your protocol specifies. Capture does not claim image analysis; it holds the structured score and the reference.
A responder analysis depends on a clean baseline and on assessments falling inside the window. Set a visit window around week 16 so a score taken at week 14 or week 19 is flagged before analysis. Capture exports include a data dictionary, so statisticians can derive PASI 75 and PASI 90 from the exported baseline and visit scores in R, SAS or SPSS; see export EDC data to R, SAS and SPSS. For the clinician-rated versus patient-reported distinction in your statistical plan, the glossary entry defines the categories.
Regional scores
Rater
RATERHead and neck score
PASIHTrunk score
PASITUpper limbs score
PASIULower limbs score
PASILPASI total
PASIDerived, read-only
4.5 CalculatedChange from baseline
PASICHGMeets 75% responder rule
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Plaque psoriasis diagnosis, minimum PASI, BSA and sPGA at screening and baseline | Eligibility screening template with range edit checks |
| Severity index | Four regional scores and total, by rater | PASI template; calculated totals |
| Global assessment | Static score on a 0 to 4 style scale | Site eCRF form per visit |
| Quality of life | Questionnaire total and itch or pain rating | DLQI template; phone questionnaire |
| Prior and concomitant therapy | Topicals, phototherapy, systemic and biologic history with dates | Concomitant medications, medical history |
| Safety laboratory | Haematology, liver and lipid panels with ranges | Lab results template |
| Arthritis screen | Joint symptoms in psoriatic disease | ACR response and DAS28 template where the protocol includes it |
| Adverse events | Infections, injection-site reactions, seriousness | 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 participants. Free sandbox, no credit card.
Safety and long-term design
Biologic and targeted oral treatments suppress parts of the immune system, so programmes commonly screen for latent tuberculosis and hepatitis before enrolment and track infections throughout. Record screening results as dated laboratory or procedure forms, with the protocol rule for eligibility written as an edit check on the eligibility form. A laboratory form with reference ranges makes drift visible, and the lab data and reference range management page explains the pattern. Be clear in your documents that these checks surface values for data managers; they do not replace the investigator safety procedures.
Many programmes randomise responders again at week 16 or 28 for a withdrawal or dose-comparison phase. Capture supports arms, epochs and randomisation in the same system; see clinical trial randomization software and blinded and unblinded role management for how blinded staff are kept from treatment-arm values. Dermatology programmes with a wider remit, including topical and cosmetic studies, are covered in EDC for dermatology clinical trials, and its eczema sibling is EDC for atopic dermatitis clinical trials.
Psoriasis programmes recruit across many sites, and the same rater consistency problem multiplies. QR-code enrolment, site-level numbering, a site coordinator portal and by-site exports keep a multi-site registrational study organised; see multi-site clinical trial management and Phase 3 EDC. Autoimmune neighbours with overlapping safety patterns are in EDC for lupus and autoimmune trials.
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 schedule and forms. Nothing is saved until a person reviews it.
Add the regional fields and let calculated fields produce the total, read-only, at each visit.
Set the week-16 window and agree who confirms baseline, so responder status derives from a verified value.
Infection screen, laboratory panels, prior therapy and adverse events, each with the edit checks your protocol needs.
Create the quality-of-life task with reminders. Participants answer through a secure link on their own phone.
Run practice participants through every visit, then approve and lock forms for live use.
Before first participant
Named raters, training record and the rule on whether the same assessor sees the participant each visit.
DLQI and any other licensed measures filed with their rights-holder terms.
Who confirms baseline PASI and sPGA and when.
Infection and laboratory eligibility rules expressed as edit checks.
CSV or Excel with the data dictionary checked in the statistics package.
Yes. Build the regional fields and use calculated fields to derive the regional and total scores, shown read-only during entry. Your protocol defines the exact scoring rules.
Capture records baseline and visit scores with an audit trail, and exports include a data dictionary, so statisticians can derive responder rates in R, SAS or SPSS. Define the rule in your statistical analysis plan.
As a phone questionnaire opened from a secure link, with reminders and a completion window. There is no app to install. The licence stays with your study documents.
You can record the date, body region and a file reference on a form. Capture does not claim image analysis, so keep the images in the system your protocol names.
Capture supports arms, epochs and randomisation in one study, with blinded roles kept from treatment-arm values.
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 via the demo page or the pricing page.
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Free sandbox with every feature. No credit card, and you pay only when you go live.