PTSD trials pair a clinician-administered interview with a participant self-report, carefully tracked suicidality and, in many designs, therapy sessions that are part of the intervention. Capture holds the rater forms, the phone questionnaires and the session records in one study. Test it free, no credit card.
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weeks
Eligibility, history
Baseline ratings
Session and monitoring records
Blinded rater
What a PTSD trial needs from its EDC
The study data
The CAPS-5 is a structured clinical interview in which a trained rater scores each DSM-5 symptom on a 0 to 4 severity scale and derives a total severity score. In registered trials of drug-assisted therapy it is a frequent primary endpoint, measured as change from baseline at a fixed point after treatment, for example eighteen weeks into the programme in one large placebo-controlled design that uses a blinded independent rater pool. The PCL-5 is a 20-item self-report of DSM-5 symptoms with a total range of 0 to 80; it is often a secondary endpoint, and some trial registrations list it as the primary. Depression, anxiety, sleep and functional measures usually follow as secondary outcomes.
Because the primary is an interview, the main data risk is rater variability and unblinding rather than arithmetic. A rater who knows the allocation, or who changes between visits, introduces noise that cannot be corrected later. In Capture each CAPS-5 style form is a site eCRF form with typed fields, a calculated total shown read-only, a named rater on every entry and an audit trail showing any later change with the reason. Where independent raters assess remotely, they can be given a restricted role; blinded roles never receive treatment-arm values, enforced by masked database views, not just by the interface. See blinded and unblinded role management.
Self-report is where the participant-experience risk sits. The PCL-5 recall period is typically the past month, and a questionnaire that is skipped during a hard week is missing precisely when it matters. A phone task with reminders and a completion window helps, and so does a plan for what site staff do when a response is overdue. The PCL-5 template shows the structure of the form without reproducing its wording, and the licence stays with your study documents.
Prospective suicidality assessment is standard in psychiatric trials. A C-SSRS template gives a visit form for the structured screen, and your protocol decides which answers require same-day follow-up. An edit check can make a qualifying answer visible to data managers and site staff, but it is a data prompt, not a clinical alerting system. Depression and sleep measures such as the PHQ-9 template and insomnia severity index template sit alongside. For psychedelic and drug-assisted designs, including the session record, see EDC for psychedelic clinical trials; the wider field is in EDC for psychiatry clinical trials.
| Blinded rater | Site clinician | Participant | |
|---|---|---|---|
| Clinician-administered interview total | |||
| Self-report symptom checklist | |||
| Suicidality screen | |||
| Session and monitoring record | |||
| Treatment-arm information |
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Diagnosis and eligibility | Index trauma, severity threshold, exclusions | Eligibility screening template with edit checks |
| Clinician-rated primary | Symptom severity scores and total, rater, timeframe | Site eCRF form with calculated total; restricted rater role |
| Self-reported symptoms | Item scores and total, recall period | PCL-5 template; phone questionnaire with reminders |
| Suicidality | Structured screen at each visit | C-SSRS template |
| Depression and sleep | Total scores and severity bands | PHQ-9, insomnia severity index, sleep diary |
| Therapy sessions | Dates, duration, therapist, notes fields | Repeating-row session form on the site eCRF |
| Randomisation and blinding | Allocation, blinded roles | Randomization software; blinded role management |
| 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 participants. Free sandbox, no credit card.
Consent, privacy and safety
PTSD participants share trauma histories, so privacy design matters. Role-based access and PII segregation let site coordinators see participant names while researchers work with coded IDs, and row-level security enforces this at the database. Data is hosted in the EU (Frankfurt) or the USA (N. Virginia), so residency can match the ethics approval; see GDPR-compliant clinical trial software and HIPAA-compliant clinical trial software for what those terms do and do not cover.
Consent should reflect the sensitive nature of the study. eConsent supports an on-screen participant signature confirmed with an email one-time code, an optional witness and investigator countersignature, with each signature linked by hash to the exact document content. The basic clinical trial consent template is a layout to start from; wording must be approved by your ethics committee. Where an impartial witness is needed, see impartial witness eConsent. The product page is eConsent.
Adverse events in PTSD programmes include psychiatric events during and after sessions, such as transient anxiety or distress, as well as physical effects such as blood pressure changes in drug-assisted designs. Record them on a structured adverse event form with onset, severity, seriousness and relationship, and use the adverse event reporting workflow for serious events. Vital signs at session visits can sit on the vital signs template with range edit checks you define.
Build sequence
A practical order of work for a sponsor or investigator team.
List rater, clinician and coordinator roles and which of them may see treatment-arm information. Build roles to match.
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.
Screening, preparation, treatment sessions, primary assessment and follow-up each get their own visit plan.
Derived totals on scales, windows around assessments, and phone questionnaires with reminders.
Run practice participants through every epoch, including a blinded rater account, and read the audit trail.
Approved forms lock for live use. Real participants start the paid live phase.
Before first participant
CAPS-5, PCL-5 and any other measures licensed through their rights holders, filed with the study documents.
Who scores the interview, how they stay blind, and how reliability is checked.
Which answers trigger follow-up, who acts, and where it is documented.
Wording reviewed by the ethics committee for a sensitive-data study.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. The interview is built as a site eCRF form with typed fields and a calculated total, and the self-report as a participant questionnaire. The licence for each instrument stays with your study documents; Capture does not supply wording or verify licences.
Yes. Blinded roles never receive treatment-arm values, enforced by masked database views and row-level security, not just the interface.
Yes. Questionnaires open from a secure link in the phone browser, with reminders and a completion window you control. No app is installed.
As a repeating-row form on the site eCRF, with fields for date, duration and your own protocol items. Each row carries its own audit trail.
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 via the demo page or the pricing page.
Keep exploring
PCL-5 eCRF template
Self-report symptom form.
C-SSRS eCRF template
Suicidality screen.
EDC for psychedelic clinical trials
Drug-assisted therapy designs.
EDC for psychiatry clinical trials
Rating scales across psychiatry.
Blinded and unblinded roles
Keep raters blind.
eConsent
Remote signature and countersignature.
Free sandbox with every feature. No credit card, and you pay only when you go live.