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Clinical competency

Understanding of trial procedures and schedule

Know the sequence, timing, and purpose of screening, preparation, dosing, scanning, follow-up, and unblinding visits. The therapist/facilitator must be able to work within the full protocol structure.

Primary clinical guidelineModern clinical

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Guidelines

3

Courses

0

Providers

0

Protocols

2

Classification

Protocol families

Source quality

Protocol paperSOP / guidebookTrial supplement

Also known as

Competence with protocol-defined session structurePrepare participants for experimental session procedures

Across the manuals

The manuals converge on the need for a therapist or facilitator to understand the full protocol sequence and to keep participant activities aligned with trial timing. Across the extracts, this includes knowing the order of key visits and phases, such as screening, preparation or introductory work, dosing, follow-up, and later study stages, with attention to when assessments are collected and how the session structure fits the wider trial. They also overlap in emphasising that timing is not just administrative, but tied to participant safety and trial integrity. The MDMA manuals highlight clear explanation of session logistics, pre-session tests, vitals, medication administration, onset, food timing, and end-of-session or overnight arrangements, while the psilocybin trial extract adds scanning, integration, questionnaires, interviews, ECGs, pharmacy coordination, and unblinding or blind break visits. The main differences are in protocol detail and scope. The MDMA extracts focus on staged psychotherapy procedures, including introductory sessions, Stage 1, Stage 2, open-label continuation, long-term follow-up, and rules around supplemental dosing, as well as separating intervention from research assessment. The psilocybin extract is more explicit about scan days, second dose timing, and blind break, and it names coordination with medical, imaging, pharmacy, and research staff.

Synthesised from the linked source documents; refreshed as the library updates.

Linked sources

The guidelines, courses, and providers that evidence this competency. Full lists are a Blossom Pro feature.

Linked guidelines (3)

  • MDMA-assisted Psychotherapy in Chronic PTSD 9/24/03, revised -01/23/2009

    MDMAEvidence score: 90

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