Risk evaluation and safety monitoring

The manuals converge on continuous safety monitoring as a core part of the role. Across screening, dosing, and follow-up, they describe active observation for adverse or concerning effects, checking whether participants still meet safety criteria, and keeping safety in view as part of the treatment process. They also agree that safety monitoring includes clear escalation when reactions are unexpected, significant, or require further response. They differ in how specifically they frame the risks and the setting. The ibogaine case report places strong emphasis on safe setting, harm minimisation, and readiness for cardiac or hemodynamic complications, while the 5-MeO-DMT study highlights tolerability, transient mild effects such as nausea and headache, and maintaining cognitive and behavioural stability between sessions. The psilocybin trials focus more on protocol-defined eligibility, adverse event surveillance, and communication within the treatment team, with one extract also noting safety as a defined secondary outcome.