Articles
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
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 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
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
Jørgen Mangor Iversen
2023-01-26 Volume 2 • Issue 3 • 2022 • Fall 2022 - Innovative Implementation of CDISC Standards
Electronic Submission and Utilization of CDISC Standardized Clinical Study Data in Japan
Yuki Ando
2023-01-14 Volume 2 • Issue 3 • 2022 • 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 Volume 2 • Issue 3 • 2022 • 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 Volume 2 • Issue 3 • 2022 • 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