Articles
99 results
Design and Development of Data Collection Instruments
Carolyn Famatiga-Fay, Julie Filipenko, Evaldas Lebedys, Derek Johnson, Rashida Rampurawala and Andrea Mulcahy
2026-02-26 Volume 6 • Issue 1 • 2026 • Winter 2026
Also a part of:
Challenges in the Maintenance of FAIR-compliant Paediatric Data-Sharing Repositories
Claudia Pansieri, Anando Sen, Annunziata D'ercole, Ronald Cornet, Victoria Hedley, Rebecca Leary, Alexandre Betourne, Sanchita Bhattacharya, Scott Shaunessy, Ramona L. Walls, Fedele Bonifazi and Mariagrazia Felisi
2026-02-26 Volume 6 • Issue 1 • 2026 • Winter 2026
Implementation of Clinical Data Interchange Standard Consortium (CDISC) standards to Real-World Data: Challenges and Strategies in SDTM Development in the Setting of Observational Studies
SARA RIZZOLI, Alessandra Ori, Alessandra Mignani, Fabio Ferri and Lucia Simoni
2026-02-26 Volume 6 • Issue 1 • 2026 • Winter 2026
Governance for Generative AI in Clinical Development: A Cross‑Sectional Survey in Japan
Munenori Takata, Mari Sugimoto, Masaharu Harada, Makoto Hiraide, Daisuke Ichikawa, Yukikazu Hayashi, Satoru Fukimbara, Takashi Kawaguchi, Hideki Suganami and Takuhiro Yamaguchi
2026-02-26 Volume 6 • Issue 1 • 2026 • Winter 2026
Participant-Centered Insights on Clinical Trial Design: A Qualitative Study of Participant Engagement in Traditional and Decentralized Trial Designs
Sudharsan Balaji Krishnaraj, Kristin M Lefebvre and Kerstin K Leuther
2026-01-07 Digital First
Also a part of:
Leveraging Large Language Models to Streamline Clinical Trial Data Administration: Balancing Efficiency with Ethical Responsibility
Amrita Ghosh and Caroline J Huang
2025-10-30 Digital First
Also a part of:
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
2025-09-25 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
2025-09-23 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
2025-09-23 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
2025-06-06 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
2025-06-06 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
2025-04-03 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
2025-04-01 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
2025-01-15 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
2025-01-15 Volume 5 • Issue 1 • 2025 • Winter 2025