Exact public version
clinical-research v1
Use when designing a prospective clinical study before submission — selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging), estimating sample size and power for two-arm designs (means / proportions / survival), or scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision. Every output is an ESTIMATE plus a named human owner (clinician / biostatistician / regulatory owner) — never clinical fact, never a finished protocol. Distinct from ra-qm-team, which handles the regulatory/QM submission (ISO 13485, EU MDR, FDA 510(k)/PMA/QSR), not the study design.
331981c3e515c6e682ec9b271f5da73e6ec6b07236c427811bbd39d1efcb4865Package contents
Manifest
Use when designing a prospective clinical study before submission — selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging), estimating sample size and power for two-arm designs (means / proportions / survival), or scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision. Every output is an ESTIMATE plus a named human owner (clinician / biostatistician / regulatory owner) — never clinical fact, never a finished protocol. Distinct from ra-qm-team, which handles the regulatory/QM submission (ISO 13485, EU MDR, FDA 510(k)/PMA/QSR), not the study design.
897ca174b9ff63c94fd0cc01718a7149deefbac2ec0c8a8d3f76449bb650f12d- SKILL.md10,974 bytes
- assets/protocol_synopsis_template.md1,950 bytes
- references/endpoint_and_power.md3,110 bytes
- references/study_design_canon.md3,078 bytes
- references/trial_operations.md2,957 bytes
- scripts/ar_evaluator.py2,754 bytes
- scripts/config_loader.py4,101 bytes
- scripts/endpoint_selector.py6,783 bytes
- scripts/onboard.py5,551 bytes
- scripts/phase_gate_scorer.py9,390 bytes
- scripts/sample_size_estimator.py8,739 bytes