Articles

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