Articles

67 results

Internships in Clinical Data Science: A Brief Report

Richard Ittenbach, Amy Neubauer and Stephen Cameron

2024-06-06 Digital First

Letter from the SCDM Chair

Patrick Nadolny

2024-04-18 Volume 4 • Issue 1 • 2024 • Spring 2024

Software Development Life Cycle

Seth Swanlund, Veronique Wilson, Vishal Kapoor, Marsha Gabbard and Chandra Srinath

2024-04-17 Volume 4 • Issue 1 • 2024 • Spring 2024

Also a part of:

Collection: GCDMP© Collection

Letter from the Chief Editor

Claudine E Moore

2024-04-17 Volume 4 • Issue 1 • 2024 • Spring 2024

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

[Attempts at] Solving the Interoperability Conundrum

Samir Jain

2024-02-13 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

Interoperability of Leigh Syndrome Patient Registry Data with Regulatory Submission Standards

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

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

Realization of Disability Equity Through Ethical Data Management Practices

Carolyn Petersen

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

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

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

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

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

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