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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
2024-01-29 Volume 4 • Issue 1 • 2024 • Spring 2024