Benchmarking Protocol Deviations and Their Variation by Major Disease Categories

The Impact of Protocol Amendments on Clinical Trial Performance and Cost

Kenneth Getz, Stella Stergiopoulos, Mary B. Short et al. · Therapeutic Innovation & Regulatory Science · 2016 · 64 citations

Pharmacy, Pharmacoeconomics, Clinical Research Regulation +13

The Life Cycle and Management of Protocol Deviations

Katharina Kurpanek, Maryrose Petrizzo, Sonia Brenner et al. · Therapeutic Innovation & Regulatory Science · 2014 · 24 citations

Computing, Computer Science, Regulatory Compliance +13

Protocol Deviations: A Holistic Approach from Defining to Reporting

Laura Galuchie, Catherine E. Stewart, Frank Meloni · Therapeutic Innovation & Regulatory Science · 2021 · 18 citations · Full text

Pharmacy, Management Information Systems, Quality Management +17

Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics

Zachary Smith, M. Wilkinson, Christopher Carney et al. · Therapeutic Innovation & Regulatory Science · 2021 · 18 citations

Management, Community Health, Logistics Management +5

Quality by Design in Clinical Trials: A Collaborative Pilot With FDA

Kenneth Sprenger, David Nickerson, Ann Meeker-O’Connell et al. · Therapeutic Innovation & Regulatory Science · 2012 · 16 citations

Public Health, Pharmacology, Clinical Trial Regulation +13