• Digital First

    Digital First


Digital First is a Collection of articles that are finalized for publication, but have not yet been assigned to an official Volume/Issue. Since these articles are published, they do include a DOI. Note that the article will remain the same, whether it appears in the Digital First Collection or a specific Volume/Issue.

Original Research


The Role of Predictive Models in Managing Operation Risk and Workload in Clinical Trial

Sina Djali

2024-01-24 Digital First

Interoperability of Leigh Syndrome Patient Registry Data with Regulatory Submission Standards

Parag Shiralkar , Pallavi Bakare , Kasey Woleben and Sophia Zilber

2024-01-29 Digital First

The Story Behind the HL7 FHIR to CDISC Mapping Implementation Guide

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 Digital First

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 Digital First

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 Digital First

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 Digital First

Opinion Papers


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 Digital First

Feasibility Assessment of Using CDISC Data Standards for In Silico Medical Device Trials

Feasibility Assessment of Using CDISC Data Standards for In Silico Medical Device Trials

Burç Aydin , Eanna Kiely and Christian Ohmann

2023-09-21 Digital First

[Attempts at] Solving the Interoperability Conundrum

Samir Jain and Samir Jain

2024-02-13 Digital First