Schizophrenia studies depend on clinician-rated scales, tight visit windows and a safety package that goes well beyond adverse event lists. Capture holds the rating forms, rater identity, safety scales, metabolic labs and exposure in one study with one audit trail. Build it free in the sandbox, no credit card.
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What a schizophrenia trial needs from its EDC
The study data
Acute schizophrenia trials commonly follow a template. Registered protocols for acute exacerbation often use change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at week 6 as the primary endpoint, with the Clinical Global Impression Severity (CGI-S) rating as a key secondary. The PANSS total runs from 30 to 210, with higher scores meaning greater severity, so a negative change from baseline indicates improvement. Maintenance and relapse-prevention studies change the endpoint to time to relapse, and negative-symptom or cognitive studies use other measures, but the pattern of repeated clinician-rated assessments is constant.
Because the primary endpoint is a rating, the quality of the rating is the quality of the study. Capture the 30 item scores as separate fields, compute totals and subscale scores in the analysis rather than asking the site to add them by hand, and record who rated, when, and in what setting. A range check on each item stops impossible scores at entry. If your protocol uses blinded centralized rating or recorded interviews, add a field for the review status so the independent review is part of the dataset instead of a side spreadsheet.
Named instruments such as PANSS are copyrighted works, so licences and rater certification stay with your study documents. Capture does not supply the instrument or verify licences; for a clinician-rated scale entered as an eCRF, no licence controls apply in the platform. Build the form with the item structure you are authorised to use, and note the licence in the trial master file. The CGI eCRF template shows the structure of a global rating.
Many participants in acute studies are in the hospital at the start and are discharged or withdrawn before the last visit. Model that explicitly with visit windows and an early-termination form so that the last observed assessment is complete and the reason is coded. The visit window calculator is useful when drafting windows, and the schedule below shows a typical six-week pattern.
| Assessment | Screen | Day 1 | Wk 1 | Wk 2 | Wk 4 | Wk 6 | Safety FU |
|---|---|---|---|---|---|---|---|
| PANSS (clinician-rated) | |||||||
| CGI-S | |||||||
| Suicidality and movement scales | |||||||
| Metabolic labs and weight | |||||||
| Adverse events |
x = done at this visit
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and diagnosis | Diagnosis confirmation, illness duration, symptom severity at screening | Screening eCRF with edit checks; medical history form |
| Efficacy ratings | Item scores, rater, date, setting, review status | Visit eCRF forms with item-level range checks |
| Global impression | Severity and improvement ratings | CGI form structure |
| Suicidality monitoring | Structured suicidal ideation and behaviour assessment | C-SSRS form structure with an edit check to prompt review |
| Movement and metabolic safety | Movement-disorder ratings, weight, waist, glucose, lipids, prolactin | Vital signs form and laboratory form |
| Exposure and adherence | Dose, titration, missed doses, injection dates | Repeating exposure form; adherence capture |
| Adverse events and concomitant medication | AE term, severity, seriousness, relationship; rescue and background medication | Adverse event form and concomitant medications form |
Questionnaire and 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 the visits and forms for review, then run a practice participant through baseline, week 6 and an early termination. Free sandbox.
Safety reporting
Antipsychotic trials carry a recognisable safety package. Beyond adverse events, protocols commonly ask for a structured suicidality assessment, movement-disorder ratings, weight and waist measurements, fasting glucose and lipids, and prolactin or related hormone levels, each on a defined schedule. The exact scales vary, and you should take them from the protocol. What the EDC contributes is making them scheduled, range-checked and linked to the adverse event record, so a worrying result is a query rather than a surprise at database lock.
A pragmatic design links the structured assessments to adverse event capture. For example, an edit check can prompt a query when a suicidality assessment records ideation at a visit but no adverse event or follow-up note exists. The C-SSRS form structure shows how such a form is laid out. Metabolic values use range-based checks on the laboratory form, and weight and waist sit on the vital signs form. Treat checks as prompts for clinicians, not automatic clinical decisions.
Adverse events keep severity, seriousness and causality as separate answers; the AE seriousness decision tree and the AE causality assessment page help teams agree conventions early. Hospitalization for worsening illness is a recurring question in schizophrenia studies, so decide in the protocol whether it is an efficacy outcome or a serious adverse event, and mirror that in the form. Serious events use the SAE report form.
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Causality is required because the event is serious.
Participants and privacy
Mental health data is sensitive, and some participants have fluctuating capacity to consent. Capture supports role-based access with PII segregation, where site coordinators see participant names and researchers see coded IDs, enforced at the database layer. eConsent supports an optional witness co-signature and a Legally Authorized Representative signature, which can help sites document the consent route the ethics committee approved; see the eConsent page. Decisions about capacity assessment remain with the investigator and the ethics committee.
Between visits, some studies add brief participant-reported measures, which open from a secure link on a phone with no app install. The wording of any instrument is yours to supply. For the wider psychiatry view, read EDC for psychiatry clinical trials, and for related neuroscience designs, EDC for CNS and neurology trials. The PHQ-9 form structure is useful when a depression measure is added.
Build sequence
A realistic order of work for a sponsor or investigator-initiated 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.
Item-level fields with range checks, rater and date fields, and a review status if independent rating applies.
Suicidality, movement, metabolic and prolactin assessments on the protocol schedule, with edit checks linking them to adverse events.
Visit windows for the acute period and an early-termination form that captures the last observed assessment.
Run practice participants through week 6 and an early exit, check the exports, approve the forms and start the paid live phase with real participants.
Sites and data out
Rating variability across sites is a recognised risk in schizophrenia studies. Capture does not replace rater training, but it makes the by-rater and by-site view possible: exports can be filtered by site and include the rater field, so a statistician or monitor can look for site-level patterns. Edit checks catch impossible entries at the source, and query management routes the rest to the right site. Multi-site operations are covered on the multi-site management page.
Exports are CSV or Excel with an automatic data dictionary, and CDISC SDTM export produces SAS XPT datasets with Define-XML (see the SDTM export page). If your design is randomized and blinded, randomization in the platform keeps allocation with the data and blinded roles never receive arm values. For Phase 2 and Phase 3 designs, see EDC for Phase 2 trials and EDC for Phase 3 trials.
Before first participant
Training and delegation records kept in the study documents for every rater.
Scale terms confirmed with their rights holders and kept in the study documents.
Windows and early-termination rules tested with practice participants.
Suicidality, movement, metabolic and hormone assessments by visit.
Whether admission for worsening illness is an efficacy outcome or an SAE.
Wide CSV with data dictionary opened in the statistics package.
Yes. Build the items as numeric fields with range checks, plus rater, date and setting. Totals can be derived in analysis. The scale wording and licence are yours to arrange; Capture does not supply instruments.
No. Licence controls exist only on participant questionnaires. For clinician-rated scales entered as eCRF forms, the licence stays with your study documents.
Yes. They are forms on the visit schedule, and edit checks can prompt a query when a result is not reflected in the adverse event record.
With visit windows and an early-termination form that captures the last observed assessment and a coded reason.
Yes. Capture is used from Phase 1 through Phase 3, with site-level numbering, a site coordinator portal and by-site exports for multi-center work.
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.
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