Articles

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

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

2023-02-27 Volume 2 • Issue 3 • 2022 • 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

2023-02-13 Volume 2 • Issue 3 • 2022 • 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 Volume 2 • Issue 3 • 2022 • 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 Volume 2 • Issue 3 • 2022 • 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 Volume 2 • Issue 3 • 2022 • Fall 2022 - Innovative Implementation of CDISC Standards