Articles
Maximizing CDISC ODM-XML for Specification of Submission Documentation
Jørgen Mangor Iversen
2023-01-25 Volume 2 • Issue 3 • 2022 • Winter 2022 - Innovative Implementation of CDISC Standards
Electronic Submission and Utilization of CDISC Standardized Clinical Study Data in Japan
Yuki Ando
2023-01-13 Volume 2 • Issue 3 • 2022 • Winter 2022 - Innovative Implementation of CDISC Standards
Implementation of COVID-19 Pandemic Impact Standards
Miho Hashio , Sarah Huggett , Stephen Hamburg , Robyn Eichenbaum and Nadeem Gul
2023-01-05 Volume 2 • Issue 3 • 2022 • Winter 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
2023-01-05 Volume 2 • Issue 3 • 2022 • Winter 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
CDISC ADaM Phases, Periods, and Subperiods: A Case Study
Jennifer Fulton
2022-12-09 Volume 2 • Issue 3 • 2022 • Winter 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
Alex C Cheng , Rhonda Facile , John Owen , Richard Marshall , Kathleen Mellars , Nan Kennedy , Brenda Minor , Kyle McGuffin and Paul Harris
2022-12-08 Volume 2 • Issue 3 • 2022 • Winter 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
2022-04-14 Volume 2 • Issue 1 • 2022 • Spring 2022