Supplementary Data and Operational Instruments for Translating ICH E6(R3) into Practice

This record contains supplementary materials supporting the master's dissertation "Translating ICH E6(R3) into Practice: A Site-Centered Operational Quality Management Framework for Shoulder Medical Device Clinical Investigations." The data workbook contains 347 site records from 45 implantable shoulder device investigations and consolidates them into 247 unique organizations. Of these, 238 were classified as academic, nonacademic hospital, or nonhospital organizations; nine remained unresolved. The regulatory derivation workbook documents the cross-analysis of ICH E8(R1), ICH E6(R3), ISO 14155:2026, and Regulation (EU) 2017/745, including the filters, domains, and gaps used to derive the site-centered framework. The remaining files are blank and simulated filled PDF versions of 24 operational quality instruments. Simulated entries are fictional. The files contain no individual participant data. The framework and instruments have not been prospectively implemented or validated at an investigational site and require local review, adaptation, approval, and validation before operational, regulatory, or clinical use.