The journal of clinical outcome assessment operations
Topic
Audit trails, attributable data, and trustworthy endpoint records.
A clinical trial guide for reconciling protocol and lab-manual identity when offered substitute collection kits, separating transport compliance from endpoint assay comparability.
A structured guide for trial endpoint leads, laboratories, and biostatisticians on evaluating endpoint observations after an analyzer service event, separating equipment release from data review and SAP handling under 42 CFR 493, ICH E6(R3), and ICH E9(R1).
A practical framework for clinical development and quality teams to validate computerized systems capturing trial endpoints—distinguishing platform qualification from protocol configuration under FDA 2024 and EMA 2023 guidelines.
