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Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary

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

2023-02-13 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

CDISC Implementation in an Academic Research Organization

Katie Jentoft, Eric Tustison and Hong Yu

2023-02-08 Fall 2022 - Innovative Implementation of CDISC Standards

Maximizing CDISC ODM-XML for Specification of Submission Documentation

Maximizing CDISC ODM-XML for Specification of Submission Documentation

Jørgen Mangor Iversen

2023-01-25 Fall 2022 - Innovative Implementation of CDISC Standards

Electronic Submission and Utilization of CDISC Standardized Clinical Study Data in Japan

Electronic Submission and Utilization of CDISC Standardized Clinical Study Data in Japan

Yuki Ando

2023-01-13 Fall 2022 - Innovative Implementation of CDISC Standards

Implementation of COVID-19 Pandemic Impact Standards

Implementation of COVID-19 Pandemic Impact Standards

Miho Hashio, Sarah Huggett, Stephen Hamburg, Robyn Eichenbaum and Nadeem Gul

2023-01-05 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

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

2023-01-05 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

CDISC ADaM Phases, Periods, and Subperiods: A Case Study

Jennifer Fulton

2022-12-09 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

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

2022-12-08 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

2022-04-28 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

2022-04-14 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

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

2022-02-03 Volume 1 • Issue 4 • 2021 • Winter 2021

Year-End Summary and Reflection of SCDM 2021

Sanjay Bhardwaj

2022-02-03 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

2022-01-27 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

2022-01-27 Fall 2021- Practice of Clinical Data Management Worldwide

Practice of Clinical Data Management Worldwide: Introduction to the Special Issue

Richard F. Ittenbach

2021-12-23 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

2021-12-17 Fall 2021- Practice of Clinical Data Management Worldwide

Clinical Data Management: A Review of Current Practice in Australia

Lauren Houston and Yasmine Probst

2021-12-17 Fall 2021- Practice of Clinical Data Management Worldwide

Data Management Plan

Data Management Plan

Evaldas Lebedys, Carolyn Famatiga-Fay, Priyanka Bhatkar, Derek Johnson, Gayathri Viswanathan and Dr. Meredith Nahm Zozus

2021-11-30 GCDMP© Collection

Also a part of:

Issue: Volume 1 • Issue 4 • 2021 • Winter 2021

CRF Completion Guidelines

CRF Completion Guidelines

Kelly Hills, Tara Bartlett, Isabelle Leconte and Dr. Meredith Nahm Zozus

2021-11-30 Volume 1 • Issue 4 • 2021 • Winter 2021

Also a part of:

Collection: GCDMP© Collection

Vendor Selection & Management

Vendor Selection & Management

Sachi Amatya and Dawn Edgerton

2021-11-30 Volume 1 • Issue 4 • 2021 • Winter 2021

Also a part of:

Collection: GCDMP© Collection

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