Articles
84 results
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
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
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
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
Introduction: Special Issue on Clinical Data Sharing
Catherine K Craven, Brian Jackson and Tony Solomonides
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
Cosmos: Real-World Data Powered by the Healthcare Community
Andrea Noel and Kersten Bartelt
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
Big Data Education for Clinical Documentation
Melinda Jenkins, Judith Katz, Courtney Omary, Suzan Ahmad, Ramya Govindarajan and Roy Simpson
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
The HIPAA Deidentification Exception Must Go
Larry Ozeran and Richard Schreiber
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
Key Considerations When Designing Real World Evidence Research Involving The Secondary Use of U.S.-Based Electronic Health Record Data
David Vulcano
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
A Privacy Nihilist’s Perspective on Clinical Data Sharing: Open Clinical Data Sharing is Dead, Long Live the Walled Garden
Justin Starren, Luke Rasmussen, Daniel Schneider, Prasanth Nannapaneni and Kelly Michelson
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
Geographic Information Systems as Data Sharing Infrastructure for Clinical Data Warehouses
Daniel R Harris
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
Realization of Disability Equity Through Ethical Data Management Practices
Carolyn Petersen
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
Evaluating individual participant data plans for ICMJE compliance: A case study at University of Michigan
Sara M. Samuel, Diane L. Wilson and Emily Fleming
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
SCDM eSource Implementation Consortium Playbook 1: Practical advice for vendors/CROs
Linda King, Jonathan Andrus, Alex Crawford and Kristen Harnack
2023-10-09 eSource Implementation Consortium
SCDM eSource Implementation Consortium Playbook 2: Taking a sites’-eye view
Linda King, Jeff Stein, Michael Buckley, Elena A Christofides, Cory Ennis and Denise Snyder
2023-10-09 eSource Implementation Consortium
SCDM eSource Implementation Consortium Playbook 3: Practical advice for pharma
Linda King, Naqib Ansari, Magda A Jaskowska, Lauren McCabe, Muzafar Mirza, Joseph Angiolelli, Peter Casteleyn, Rakesh Maniar and Nadir Ammour
2023-10-09 eSource Implementation Consortium
SCDM eSource Implementation Consortium Playbook 4: A personal regulatory view
Linda King and Mitra Rocca
2023-10-09 eSource Implementation Consortium
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
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
NCI-EVS: Building the Semantic Infrastructure to Support CDISC Data Standards and Real-World Data
Erin E Muhlbradt, Jordan V Li, Lori Whiteman and Lyubov Remennik
2023-06-19 Volume 3 • Issue 1 • 2023 • Spring 2023
Also a part of:
Dissemination of CDASH eCRFs via the CDISC Electronic Case Report Form (eCRF) Portal and the OpenClinica Electronic Data Capture system
Galen Quan Tran and Cal Collins
2023-06-01 Volume 3 • Issue 1 • 2023 • Spring 2023
Also a part of:
CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation
Geoffrey Mann, Thomas J Pedersen, Rebecca Lyzinski, Anisa Scott, Andrew J Foglia, John Cromer, Meichen Dong, Nora Varga, Sam Gardner, Christopher J Kirchberg, Byron A Wingerd, Russell D Wolfinger and Wenjun Bao
2023-05-10 Volume 3 • Issue 1 • 2023 • Spring 2023
Integration of Clinical Trial and Real-World Data: A Case Study Examination of CDISC Standards
Jennifer Sniadecki, Kathy Lucey and Dan Shiu
2023-04-14 Volume 3 • Issue 1 • 2023 • Spring 2023
Leveraging Biolink as a “Rosetta Stone” Between C-Path and EJP-RD Semantic Models Provides Emergent Interoperability
Pablo Alarcon, Ian Braun, Emily Hartley, Daniel Olson, Nirupama Benis, Ronald Cornet, Mark Wilkinson and Ramona L. Walls
2023-04-14 Volume 3 • Issue 1 • 2023 • Spring 2023
Use of CDISC data in the Danish Medicines Agency
Claus Bang Pedersen, Zhiyi You and Jesper Kjær
2023-02-27 Fall 2022 - Innovative Implementation of CDISC Standards