Articles
80 results
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
Also a part of:
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
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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
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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
2022-04-01 Volume 2 • Issue 1 • 2022 • Spring 2022
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
Year-End Summary and Reflection of SCDM 2021
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
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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
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Issue: Volume 1 • Issue 3 • 2021 • Fall 2021- Practice of Clinical Data Management Worldwide
Practice of Clinical Data Management Worldwide: Introduction to the Special Issue
Richard F. Ittenbach
2021-12-24 Volume 1 • Issue 3 • 2021 • Fall 2021- Practice of Clinical Data Management Worldwide
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Special Issue: Fall 2021- Practice of Clinical Data Management Worldwide
Clinical Data Management in Japan: Past, Present, and Future
Takuhiro Yamaguchi, Tempei Miyaji, Yukikazu Hayashi and Hideki Suganami
2021-12-18 Volume 1 • Issue 3 • 2021 • Fall 2021- Practice of Clinical Data Management Worldwide
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Special Issue: Fall 2021- Practice of Clinical Data Management Worldwide
Clinical Data Management: A Review of Current Practice in Australia
Lauren Houston and Yasmine Probst
2021-12-18 Fall 2021- Practice of Clinical Data Management Worldwide
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Issue: Volume 1 • Issue 3 • 2021 • Fall 2021- Practice of Clinical Data Management Worldwide
Data Management Plan
Evaldas Lebedys, Carolyn Famatiga-Fay, Priyanka Bhatkar, Derek Johnson, Gayathri Viswanathan and Dr. Meredith Nahm Zozus
2021-12-01 GCDMP© Collection
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CRF Completion Guidelines
Kelly Hills, Tara Bartlett, Isabelle Leconte and Dr. Meredith Nahm Zozus
2021-12-01 Volume 1 • Issue 4 • 2021 • Winter 2021
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Vendor Selection & Management
Sachi Amatya and Dawn Edgerton
2021-12-01 Volume 1 • Issue 4 • 2021 • Winter 2021
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Writing for Publication in Informatics and Data Science in Clinical Research
Richard Ittenbach and William A Ittenbach
2021-08-30 Volume 1 • Issue 2 • 2021 • Summer 2021
eSource for Standardized Health Information Exchange in Clinical Research: A Systematic Review of Progress in the Last Year
Maryam Garza, Sahiti Myneni, Susan H. Fenton and Meredith Nahm Zozus
2021-08-30 Volume 1 • Issue 2 • 2021 • Summer 2021
Risk-based Quality Management in CDM An inquiry into the value of generalized query-based data cleaning
Peter G Stokman, Lisa Ensign, Dirk Langeneckhardt, Monika Mörsch, Kristin Nuyens, Diego Herrera, Gernot Hochgräber, Valérie Cassan, Philip Beineke, Richard Kwock, Annemarie Voortman, Sven Vogelgesang, Sami Boussetta and Bradley Bitzer
2021-03-13 Volume 1 • Issue 1 • 2021 • Spring 2021
Direct Data Extraction and Exchange of Local Labs for Clinical Research Protocols: A Partnership with Sites, Biopharmaceutical Firms, and Clinical Research Organizations
Michael Buckley, Aruna Vattikola, Rakesh Maniar and Hugh Dai
2021-03-13 Volume 1 • Issue 1 • 2021 • Spring 2021
Electronic Data Capture-Selecting an EDC System
Maxine Pestronk, Derek Johnson, Muthamma Muthanna, Olivia Montano, Denise Redkar-Brown, Ralph Russo, Shweta Kerkar and David Eade
2021-03-13 Volume 1 • Issue 1 • 2021 • Spring 2021
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Electronic Data Capture-Study Implementation and Start-up
David Eade, Maxine Pestronk, Ralph Russo, Muthamma Muthanna, Derek Johnson, Denise Redkar-Brown, Olivia Montano, Shweta Kerkar and Meredith Nahm Zozus
2021-03-13 GCDMP© Collection
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