Клинические отчёты по стандартам ICH и CONSORT

★ 7.0 · documentation

clinical-reports is a Claude Code skill that generates safety-bounded draft structures and runs local deterministic checks for clinical case reports, diagnostic scaffolds, trial results manuscripts, Clinical Study Reports, and aggregate safety or research summaries. Each artifact is routed to the applicable reporting guidance — CARE 2013, CONSORT 2025, SPIRIT 2025, ICH E3, E2A, E2D(R1), CAP Cancer Protocols, ACR parameters, and others — while a provenance manifest with SHA-256 value hashes tracks every populated field to a verified source fact. The skill operates exclusively on synthetic, de-identified, or aggregate inputs with no network access, external APIs, or credentials; Python 3.11+ is required only for optional local scripts. All outputs are visibly marked DRAFT and require qualified clinical, statistical, regulatory, or legal review before any use, filing, or submission.