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92 results

Letter from the Chief Editor

Claudine Moore

2025-09-30 Volume 5 • Issue 3 • 2025 • Fall 2025

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:

Issue: Volume 5 • Issue 3 • 2025 • Fall 2025

Collection: eSource Implementation Consortium

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

Along the Way

Meredith Nahm Zozus

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

Letter from the SCDM Chair

Carol Schaffer

2025-06-05 Volume 5 • Issue 2 • 2025 • Spring 2025

Guidance for eCOA Development in Clinical Trials

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:

Issue: Volume 5 • Issue 2 • 2025 • Spring 2025

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:

Issue: Volume 5 • Issue 2 • 2025 • Spring 2025

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:

Issue: Volume 5 • Issue 2 • 2025 • Spring 2025

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

Letter from the SCDM Chair

Letter from the SCDM Chair

Patrick Nadolny

2025-01-13 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:

Collection: Digital First

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

Letter from the Chief Editor

Claudine E Moore

2024-08-26 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