Psychedelic trials combine psychotherapy, long monitored dosing sessions, intensive safety assessment and scheduled substances. Capture structures preparation, dosing and integration visits, session vitals and safety forms, and kit accountability in one study.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Scr | Prep 1 | Prep 2 | Dose | Int 1 | Int 2 | W6 | W12 |
|---|---|---|---|---|---|---|---|---|
| Primary rating scale | ||||||||
| C-SSRS | ||||||||
| Session vitals (repeated) | ||||||||
| Acute experience questionnaire | ||||||||
| Integration session log |
Prep = preparation, Int = integration
What matters in psychedelic trials
Study design
A typical psychedelic trial includes preparation sessions before dosing, one or more long dosing sessions with trained monitors present, and integration sessions afterwards. Each session type has its own data: therapist notes on preparation, repeated vital signs and adverse events during dosing, and integration attendance. The study schedule needs to hold all of them, with windows that keep dosing and follow-up in the right order.
Endpoints are usually clinician-rated scales for the condition (for depression or PTSD, for example the PCL-5 for self-report alongside clinician-rated measures), measured at fixed times after dosing to assess how long effects last. Acute subjective effects during the session are often measured with validated questionnaires shortly afterwards.
Independent raters who are not present at dosing sessions and do not know the session content are commonly used for primary outcomes. Asking participants and raters to guess the allocation at the end helps quantify functional unblinding. Blinded roles in Capture never receive the treatment arm from the server.
Study coordinator
Subject 01-004
Randomized · R-0012
KitK-10418
Arm columnNot sent
Unblinded administrator
Subject 01-004
Randomized · R-0012
KitK-10418
Arm columnA
Same subject, same screen. The arm never reaches blinded roles.
Dosing sessions
Session vitals and observations are recorded as repeating rows with times, each row carrying its own audit trail. Adverse events use the AE form with the minimum dataset enforced, and serious events raise routed safety alerts straight away. Discharge criteria can be recorded as a checklist on the session form.
Cannot submit yet
Causality is required because the event is serious.
Controlled substances
Randomisation, kit dispensing and drug accountability run in the same system as the EDC. Kits are dispensed under electronic signature, accountability reports and CSV exports are available, and blinded roles see "Treatment assignment blinded" everywhere.
1 of 2 kits confirmed
Set it up in the free sandbox.
Data map
| Session | Data |
|---|---|
| Screening | Eligibility, psychiatric history, suicidality, cardiovascular screening, prohibited medications |
| Preparation | Attendance, therapist, session duration |
| Dosing | Dose and time, repeated vitals, observations, adverse events, discharge criteria |
| Post-dosing | Acute experience questionnaires, overnight follow-up if required |
| Integration | Attendance, therapist, duration |
| Follow-up | Primary and secondary scales, suicidality, durability of effect |
Study build
Preparation, dosing and integration visits with windows.
Timed vitals, observations and discharge criteria.
Primary outcome raters separated from sessions.
Allocation guesses from participants and raters.
C-SSRS at every contact where required.
Dispensing and accountability complete.
Typically several hours, depending on the drug, with monitoring throughout and defined discharge criteria.
Yes, as scheduled visits with attendance, therapist and duration fields.
Yes. FDA issued draft guidance on clinical investigations of psychedelic drugs in 2023. Check the current status and any national requirements.
When participants or staff can tell which treatment was given from its effects, which can bias outcomes. Independent raters and blinding assessments help manage it.
Yes, as repeating rows with times, each with its own audit trail.
Kits are dispensed under electronic signature, with accountability reports and exports in the same system as the EDC.
Yes. The C-SSRS template can be scheduled at every contact.
Yes, in the free sandbox with every feature.
Sessions, safety and accountability in one study. Free sandbox.