Articles
67 results
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
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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
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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
2023-02-28 Fall 2022 - Innovative Implementation of CDISC Standards
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Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary
Anando Sen, Victoria Hedley, John Owen, Ronald Cornet, Dipak Kalra, Corinna Engel, Avril Palmeri, Joanne Lee, Jean-Christophe Roze, Joseph F Standing, Adilia Warris, Claudia Pansieri, Rebecca Leary, Mark Turner and Volker Straub
2023-02-14 Fall 2022 - Innovative Implementation of CDISC Standards
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Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
The United States Food and Drug Administration’s Innovative Alternative Tools to Evaluate Good Clinical Practice During the COVID-19 Public Health Emergency
Kassa Ayalew, Jenn Sellers, Phillip D. Kronstein, Laurie Muldowney, Emily Gebbia, Jean Mulinde and David Burrow
2023-02-10 Volume 2 • Issue 2 • 2022 • Summer 2022
CDISC Implementation in an Academic Research Organization
Katie Jentoft, Eric Tustison and Hong Yu
2023-02-08 Fall 2022 - Innovative Implementation of CDISC Standards
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Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
Maximizing CDISC ODM-XML for Specification of Submission Documentation
Jørgen Mangor Iversen
2023-01-26 Fall 2022 - Innovative Implementation of CDISC Standards
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Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
Electronic Submission and Utilization of CDISC Standardized Clinical Study Data in Japan
Yuki Ando
2023-01-14 Fall 2022 - Innovative Implementation of CDISC Standards
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Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
Implementation of COVID-19 Pandemic Impact Standards
Miho Hashio, Sarah Huggett, Stephen Hamburg, Robyn Eichenbaum and Nadeem Gul
2023-01-06 Fall 2022 - Innovative Implementation of CDISC Standards
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Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
Developing Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) Liver Fibrosis
Y. Veronica Pei, Vaishali Popat, Aaron Belowich and Chenoa Conley
2023-01-06 Fall 2022 - Innovative Implementation of CDISC Standards
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Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
What and how will the Risk Based Approach to Monitoring change? Survey of RBM in medical institutions
Kiyoko Adachi, Mayumi Shirase, Yukie Kimura, Yasutoshi Kuboki and Takayuki Yoshino
2022-12-16 Volume 2 • Issue 2 • 2022 • Summer 2022
CDISC ADaM Phases, Periods, and Subperiods: A Case Study
Jennifer Fulton
2022-12-10 Fall 2022 - Innovative Implementation of CDISC Standards
Also a part of:
Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
Making Clinical Data Acquisition Standards Harmonization (CDASH) Electronic Case Report Forms Available on the REDCap Shared Data Instrument Library
Alex C Cheng, Rhonda Facile, John Owen, Richard Marshall, Kathleen Mellars, Nan Kennedy, Brenda Minor, Kyle McGuffin and Paul Harris
2022-12-09 Fall 2022 - Innovative Implementation of CDISC Standards
Also a part of:
Issue: Volume 2 • Issue 3 • 2024 • Fall 2022 - Innovative Implementation of CDISC Standards
The implementation of a data learning series focused on clinical development teams in a contract research organization
Stacy A Weil, Allison Crumpler and Sharon V Medendorp
2022-04-29 Volume 2 • Issue 1 • 2022 • Spring 2022
Institutional Change in Clinical Trials in the era of the COVID-19 Pandemic
Tempei Miyaji, Takahiro Kiuchi, and Takuhiro Yamaguchi
2022-04-15 Volume 2 • Issue 1 • 2022 • Spring 2022
A Note of Special Appreciation to JSCDM’s Peer Reviewers
Richard Ittenbach and Meredith Nahm Zozus
2022-03-31 Volume 2 • Issue 1 • 2022 • Spring 2022
Year-End Summary and Reflection of SCDM 2021
Sanjay Bhardwaj
2022-02-04 Volume 1 • Issue 4 • 2021 • Winter 2021
Bring Your Own Device: A Practical Framework to Leverage in the Electronic Patient-reported Outcomes Data Collection in Clinical Trials
Aman Thukral, Kelsey Linsmeier, Brooks Fowler and Sanjay Bhardwaj
2022-02-04 Volume 1 • Issue 4 • 2021 • Winter 2021
Clinical Data Management in the United States: Where We Have Been and Where We Are Going
Mary A. Banach, Kaye H. Fendt, Johann Proeve, Dale Plummer, Samina Qureshi and Nimita Limaye
2022-01-28 Volume 1 • Issue 3 • 2021 • Fall 2021- Practice of Clinical Data Management Worldwide
Also a part of:
Special Issue: Fall 2021- Practice of Clinical Data Management Worldwide
The Untapped Potential of Clinical Data Management in Ukraine: A Novel Training Program Case Study
Sergey Glushakov and Volodymyr Boichuk
2022-01-28 Fall 2021- Practice of Clinical Data Management Worldwide
Also a part of:
Issue: Volume 1 • Issue 3 • 2021 • Fall 2021- Practice of Clinical Data Management Worldwide