Articles

67 results

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

2023-08-10 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

2023-06-20 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

2023-02-28 Fall 2022 - Innovative Implementation of CDISC Standards

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

2023-02-14 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

2023-01-26 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

2023-01-14 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

2023-01-06 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

2023-01-06 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

2022-12-10 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

2022-12-09 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

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