Articles
92 results
Implementation of a Fully Decentralized Clinical Trial Design in a Psycho-Oncology Trial
Tomoe Mashiko, Tempei Miyaji, Tatsuo Akechi and Takuhiro Yamaguchi
2025-09-26 Volume 5 • Issue 3 • 2025 • Fall 2025
Initiative for CDISC Standardization of Clinical Trial Data in Academia: The Experience of Tohoku University Hospital
Yuko Yamada, Shih-Wei Chiu, Munenori Takata, Takayo Suzuki, Saori Kanatsu, Miyuki Ishiguro, Junya Kimura and Takuhiro Yamaguchi
2025-09-25 Volume 5 • Issue 3 • 2025 • Fall 2025
SCDM Executive Committee Perspective: The Future of Clinical Trials with AI and Decentralized, Hybrid and Data-driven approaches
Ward Lemaire, Patrick Nadolny, Jonathan Andrus, Carol Schaffer and Stephen Cameron
2025-09-24 Volume 5 • Issue 3 • 2025 • Fall 2025
Assessment of the Scope and Geographic Distribution of the United States FDA’s Good Clinical Practice (GCP) Inspections
Kassa Ayalew, Jenn Sellers, Ling Yang, Hanah Pham, Wanjiku Mwangi, Phuc Nguyen and Mathew Thomas
2025-09-23 Volume 5 • Issue 3 • 2025 • Fall 2025
Research Electronic Data Capture Using REDCap and External Data Quality Pipeline Development
Cherise R Chin Fatt, Ryan Y Becker, Lorraine Burkhalter, Brennan Dawson, Thomas J Carmody and Madhukar H Trivedi
2025-09-22 Volume 5 • Issue 3 • 2025 • Fall 2025
Real-time Perspectives on the Transition to eSource: SCDM Best Practice Consensus Recommendations for Implementation and Scalability
Linda King, Michael Buckley, Amy Cramer, Muzafar Mirza, Cory Ennis, Lauren F McCabe, Cal Collins and Aruna Vattikola
2025-09-22 SCDM Annual Conference Collection
Also a part of:
Developing FHIR based Activity Libraries to Support Clinical Trial Direct Data Capture
Patrick Genyn and Andy Richardson
2025-07-21 Digital First
Developing an Electronic Data Capture System for Study Enrollment and Surveys using REDCapCloud.com within the US Air Force
Matthew J Gdovin, Dianna Herrera, Katharine K McMillan, August N Blackburn and Lauren E Cornell
2025-06-05 Volume 5 • Issue 2 • 2025 • Spring 2025
Current Opportunities for the Integration and Use of Artificial Intelligence and Machine Learning in Clinical Trials: Good Clinical Practice Perspectives
Joseph Geraci, Prasanna Rao, Cheryl Grandinetti, Bessi Qorri, Patrick Nadolny, Kassa Ayalew, Lisbeth Bregnhøj, Lindsay Edwards, Karen Hofmann, Sean Khozin, Nicolas Schaltenbrand, Torsten Stemmler, Alan Yeomans, Demetris Zambas and Ni Khin
2025-06-05 Volume 5 • Issue 2 • 2025 • Spring 2025
Guidance for eCOA Development in Clinical Trials
Sachi Amatya, Ed.D., MBA, CCDM, Erica Sage and Dawn Edgerton
2025-04-22 GCDMP© Collection
Also a part of:
Enhancing Medicine Information Services: A Future-Proof, Low-Cost Data Management Strategy
Tamara Lebedevs, Claire Broderick, Stephanie WK Teoh, Nabeelah Mukadam and Jennifer Frestel
2025-04-02 Digital First
Also a part of:
Navigating the path to Ethical & Responsible AI integration in Health & Life Sciences with Human and Machine Collaboration
Shobhit Shrotriya, Nizar Banu, Avi Kulkarni and Sujata Aiyangar
2025-03-31 Digital First
Also a part of:
Automating Data Entry from Electronic Health Record to Electronic Data Capture Using Trusted Cloud-based Application in Multisite Cancer Clinical Trials
Keith Goodman, Chris Cook, Dani Weatherbee, Sunita Yadav, Dinesh Pal Mudaranthakam, Rachael Sexton, Nichole Mahaffey, Leslie Garcia, Teresa Ta, Erin Cebula, Janie Smart, Tanya Goudeau, Sandy Annis, Aubrey Gilmore, Daria Chugina, Pasarlai Ahmadzai, Antje Hoering and Michael LeBlanc
2025-01-14 Volume 5 • Issue 1 • 2025 • Winter 2025
Clinical Data Standards and Data Anonymization Considerations for Academic Organizations: International Cross-Sectional Survey
Davide Gaudesi, Richard Ittenbach, Stephen Cameron, Hong Yu, Olusegun Adegoke, Tempei Miyaji, Alexander John Ching Bragat and Reza Rostami
2025-01-14 Volume 5 • Issue 1 • 2025 • Winter 2025
Analysis of Core Competencies for the Clinical Data Management Profession in Japan
MUNENORI TAKATA, Tempei Miyaji, Yukikazu Hayashi, Shoji Sanada and Takuhiro Yamaguchi
2024-11-25 Volume 5 • Issue 1 • 2025 • Winter 2025
Evaluation and Use of Natural Language Processing (NLP) Reasoning and Classification Models to Support Clinical Trial Patient Identification and Enrollment in the Community Oncology Setting
Christopher Tristen Rocha, Inji Hankala, Linh Mekuria, Owen McEvoy, Johnny Walker, Randy Erickson and Patricia Goede
2024-10-31 Volume 5 • Issue 1 • 2025 • Winter 2025
Also a part of:
Representing Clinical Study Schedule of Activities as FHIR Resources: Required Characteristic Attributes
Andy Richardson
2024-08-28 Volume 4 • Issue 2 • 2024 • Summer 2024
Clinical Data Warehousing: A Scoping Review
Zhan Wang, Catherine Craven, Mahanaz Syed, Melody Greer, Emel Seker, Shorab Syed and Meredith Nahm Zozus
2024-08-28 Volume 4 • Issue 2 • 2024 • Summer 2024
Transformation from Data Management to Data Science Enabled Organization - Where Are We Heading?
Miho Hashio, Michal Kolodziej, Mike Olds, Elizabeth Samuel, Suraj Ravindran, Arshad Mohammed and Marcin Makowski
2024-08-28 Volume 4 • Issue 2 • 2024 • Summer 2024
Need for Data Standardization and Infrastructure of Research Data Management to Promote Using Real-world Data
Satoshi Ueno, Yusuke Komiyama, Mariko Doi and Keika Hoshi
2024-07-30 Volume 4 • Issue 2 • 2024 • Summer 2024