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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

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

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

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

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:

Issue: Volume 3 • Issue 2 • 2023 • Summer 2023

Dissemination of CDASH eCRFs via the CDISC Electronic Case Report Form (eCRF) Portal and the OpenClinica Electronic Data Capture system

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:

Issue: Volume 3 • Issue 2 • 2023 • Summer 2023

CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation

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

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

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

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