Provides a comprehensive, practice-aligned protocol for biospecimen management in clinical research: intake questionnaires, specimen-specific collection procedures, labeling, chain-of-custody, cold-chain monitoring, shipping/receiving, inventory lifecycle, and quality-audit checklists. It codifies ISBER, NCI, CAP/CLIA and ICH-GCP best practices so teams can produce auditable Trial Master File documentation.
Use this skill when designing or auditing biospecimen SOPs for clinical studies, setting up central lab shipping and LIMS integration, training site staff on collection/labeling, or investigating potential cold-chain or chain-of-custody incidents. It's most valuable for clinical research managers, lab leads, and quality teams.
Best consumed by knowledge-agent assistants and clinical-operations automation; uses plain-text guidance suitable for Claude/Codex-style agents and documentation pipelines.
This skill has not been reviewed by our automated audit pipeline yet.
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