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Volume 4 • Issue 1 • 2024 • Spring 2024
Letter
Consensus Papers
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes
Patricia Shepherd Delong, Demian Humler, Tom Haag, Alan Yeomans, Jonathan Andrus, Sonya Eremenco, Ashley Finan, Jonathon Gable, Derek Gilfillan, Cindy Howry, Scottie Kern, Scott Lesniewski, Kelly Simpliciano, Hannah Staunton, Jess Turnbull, Christina Workman and Stephen Raymond
2023-12-14 Volume 4 • Issue 1 • 2024 • Spring 2024
Design Manuscripts
The Endpoints Dataset: A Quality Control Method for Review and Analysis of Critical Efficacy Endpoints Data
Timothy Edward Breen and Adelai U Neal
2024-01-09 Volume 4 • Issue 1 • 2024 • Spring 2024
Opinion Papers
[Attempts at] Solving the Interoperability Conundrum
Samir Jain
2024-02-13 Volume 4 • Issue 1 • 2024 • Spring 2024
Exploration on Standardization of Clinical Research Data in a Clinical Trial Institute of Traditional Chinese Medicine
Li Qingna, Rui Gao, Zhao Yang, Fang Lu and Xu Hao
2023-12-13 Volume 4 • Issue 1 • 2024 • Spring 2024
Feasibility Assessment of Using CDISC Data Standards for In Silico Medical Device Trials
Burç Aydin, Eanna Kiely and Christian Ohmann
2023-09-21 Volume 4 • Issue 1 • 2024 • Spring 2024
Original Research
Comparison of electronic health records and electronic source data in clinical research trials: a retrospective review
Elena A Christofides, Amelia Tian, Nicole Mastacouris, Ada Zhu and Olivia Dennis
2024-03-06 Volume 4 • Issue 1 • 2024 • Spring 2024
The Role of Predictive Models in Managing Operation Risk and Workload in Clinical Trial
Sina Djali
2024-01-24 Volume 4 • Issue 1 • 2024 • Spring 2024
Basic Data Structure for Hierarchical Composite Endpoints: An Application to Kidney Disease Trials
Samvel B Gasparyan, Nicole Major, Christoffer Bäckberg, Srivathsa Ravikiran, Parag Wani and Martin Karpefors
2024-02-08 Volume 4 • Issue 1 • 2024 • Spring 2024
The Story Behind the HL7 FHIR to CDISC Mapping Implementation Guide
Rebecca L. Baker, Mike Hamidi, Lloyd McKenzie, Christine K. Denney and Theresia D. Edgar
2023-08-09 Volume 4 • Issue 1 • 2024 • Spring 2024
Interoperability of Leigh Syndrome Patient Registry Data with Regulatory Submission Standards
Parag Shiralkar, Pallavi Bakare, Kasey Woleben and Sophia Zilber
2024-01-30 Volume 4 • Issue 1 • 2024 • Spring 2024