Articles
99 results
Geographic Information Systems as Data Sharing Infrastructure for Clinical Data Warehouses
Daniel R Harris
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
Realization of Disability Equity Through Ethical Data Management Practices
Carolyn Petersen
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
Evaluating individual participant data plans for ICMJE compliance: A case study at University of Michigan
Sara M. Samuel, Diane L. Wilson and Emily Fleming
2023-11-08 Winter 2023 - Special Issue on Clinical Data Sharing
SCDM eSource Implementation Consortium Playbook 1: Practical advice for vendors/CROs
Linda King, Jonathan Andrus, Alex Crawford and Kristen Harnack
2023-10-09 eSource Implementation Consortium
SCDM eSource Implementation Consortium Playbook 2: Taking a sites’-eye view
Linda King, Jeff Stein, Michael Buckley, Elena A Christofides, Cory Ennis and Denise Snyder
2023-10-09 eSource Implementation Consortium
SCDM eSource Implementation Consortium Playbook 3: Practical advice for pharma
Linda King, Naqib Ansari, Magda A Jaskowska, Lauren McCabe, Muzafar Mirza, Joseph Angiolelli, Peter Casteleyn, Rakesh Maniar and Nadir Ammour
2023-10-09 eSource Implementation Consortium
SCDM eSource Implementation Consortium Playbook 4: A personal regulatory view
Linda King and Mitra Rocca
2023-10-09 eSource Implementation Consortium
Feasibility Assessment of Using CDISC Data Standards for In Silico Medical Device Trials
Burç Aydin, Eanna Kiely and Christian Ohmann
2023-09-21 Volume 4 • Issue 1 • 2024 • Spring 2024
The Story Behind the HL7 FHIR to CDISC Mapping Implementation Guide
Rebecca L. Baker, Mike Hamidi, Lloyd McKenzie, Christine K. Denney and Theresia D. Edgar
2023-08-09 Volume 4 • Issue 1 • 2024 • Spring 2024
NCI-EVS: Building the Semantic Infrastructure to Support CDISC Data Standards and Real-World Data
Erin E Muhlbradt, Jordan V Li, Lori Whiteman and Lyubov Remennik
2023-06-19 Volume 3 • Issue 1 • 2023 • Spring 2023
Also a part of:
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
Also a part of:
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
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
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
Claus Bang Pedersen, Zhiyi You and Jesper Kjær
2023-02-27 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
2023-02-13 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 Fall 2022 - Innovative Implementation of CDISC Standards
Maximizing CDISC ODM-XML for Specification of Submission Documentation
Jørgen Mangor Iversen
2023-01-25 Fall 2022 - Innovative Implementation of CDISC Standards
Electronic Submission and Utilization of CDISC Standardized Clinical Study Data in Japan
Yuki Ando
2023-01-13 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
2023-01-05 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
2023-01-05 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
CDISC ADaM Phases, Periods, and Subperiods: A Case Study
Jennifer Fulton
2022-12-09 Fall 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 Fall 2022 - Innovative Implementation of CDISC Standards