The journal of clinical outcome assessment operations
Category
Electronic assessments, devices, sensors, and decentralized measurement.
A methodological guide for clinical development and biostatistics teams on FDA, EMRN V02, and ICH E6(R3) Annex 2 rules for collecting trial endpoints away from traditional sites.
A practical release framework for endpoint and data management leads: separating eCOA measurement alterations from schedule and configuration changes under 21 CFR 312.30, 21 CFR 56.108, final PFDD Guidance 3, and EMA Annex 2.10.
A methodological guide for clinical development and biostatistics teams to evaluate measurement comparability across paper, tablet, smartphone, and web modes under the 2023 ISPOR Task Force rule and October 2025 FDA PFDD Guidance 3.
An evidence-based guide to validating digital health technologies (DHTs) for clinical trial endpoints under FDA's December 2023 guidance, covering verification, validation, and missing data.
