Articles

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 • Winter 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 • Winter 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

2023-01-05 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

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

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

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

A Note of Special Appreciation to JSCDM’s Peer Reviewers

Richard Ittenbach and Meredith Nahm Zozus

2022-03-31 Volume 2 • Issue 1 • 2022 • Spring 2022