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Volume 6 • Issue 1 • 2026 • Winter 2026

Letters


Letter from JSCDM Team

Triphine Dusabimana

2026-02-25 Volume 6 • Issue 1 • 2026 • Winter 2026

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

2026-02-25 Volume 6 • Issue 1 • 2026 • Winter 2026

GCDMP©


Design and Development of Data Collection Instruments

Design and Development of Data Collection Instruments

Carolyn Famatiga-Fay, Julie Filipenko, Evaldas Lebedys, Derek Johnson, Rashida Rampurawala and Andrea Mulcahy

2026-02-25 Volume 6 • Issue 1 • 2026 • Winter 2026

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Collection: GCDMP© Collection

Original Research


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

2026-01-06 Digital First

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Issue: 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

2026-02-25 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

2026-02-25 Volume 6 • Issue 1 • 2026 • Winter 2026

Opinion Papers


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

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Issue: Volume 6 • Issue 1 • 2026 • Winter 2026