Innovations in Clinical Trials and Research Data Management

Data Flow Construction and Quality Evaluation of Electronic Source Data in Clinical Trials: Pilot Study Based on Hospital Electronic Medical Records in China

Yannan Yuan, Yun Mei, Shuhua Zhao, Shenglong Dai, Xiaohong Liu, Xiaojing Sun, Zhiying Fu, Liheng Zhou, Jie Ai, Liheng Ma, Min Jiang

JMIR Med Inform 2024 (Jun 27); 12:e52934

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Remote Inclusion of Vulnerable Users in mHealth Intervention Design: Retrospective Case Analysis

Ingjerd J Straand, Kimberley A Baxter, Asbjørn Følstad

JMIR Mhealth Uhealth 2024 (Jun 14); 12:e55548

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Combating Fraudulent Participation in Urban American Indian and Alaska Native Virtual Health Research: Protocol for Increasing Data Integrity in Online Research (PRIOR)

Nicole D Reed, Sheana Bull, Umit Shrestha, Michelle Sarche, Carol E Kaufman

JMIR Res Protoc 2024 (Jun 13); 13:e52281

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Evaluating the Problem of Fraudulent Participants in Health Care Research: Multimethod Pilot Study

Vithusa Kumarasamy, Nicole Goodfellow, Era Mae Ferron, Amy L Wright

JMIR Form Res 2024 (Jun 04); 8:e51530

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Identifying Existing Guidelines, Frameworks, Checklists, and Recommendations for Implementing Patient-Reported Outcome Measures: Protocol for a Scoping Review

Randi Thisakya Jayasinghe, Susannah Ahern, Ashika D Maharaj, Lorena Romero, Rasa Ruseckaite

JMIR Res Protoc 2024 (May 21); 13:e52572

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Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study

Yan Jia, Qi Li, Xiaowen Zhang, Yi Yan, Shiyan Yan, Shunping Li, Wei Li, Xiaowen Wu, Hongguo Rong, Jianping Liu

J Med Internet Res 2024 (May 08); 26:e45719

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Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned

Sara Shaw Green, Sung-Jae Lee, Samantha Chahin, Meardith Pooler-Burgess, Monique Green-Jones, Sitaji Gurung, Angulique Y Outlaw, Sylvie Naar

JMIR Form Res 2024 (May 02); 8:e46420

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Psychotherapy for Ketamine’s Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized Controlled Trial

Akash Goel, Bhavya Kapoor, Hillary Chan, Karim Ladha, Joel Katz, Hance Clarke, Janneth Pazmino-Canizares, Zaaria Thomas, Kaylyssa Philip, Gabriella Mattina, Paul Ritvo

JMIR Res Protoc 2024 (Apr 17); 13:e54406

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Investigating the Roles and Responsibilities of Institutional Signing Officials After Data Sharing Policy Reform for Federally Funded Research in the United States: National Survey

Jinyoung Baek, Jonathan Lawson, Vasiliki Rahimzadeh

JMIR Form Res 2024 (Mar 20); 8:e49822

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Blockchain-Based Dynamic Consent and its Applications for Patient-Centric Research and Health Information Sharing: Protocol for an Integrative Review

Wendy M Charles, Mark B van der Waal, Joost Flach, Arno Bisschop, Raymond X van der Waal, Hadil Es-Sbai, Christopher J McLeod

JMIR Res Protoc 2024 (Feb 05); 13:e50339

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A Pragmatic Method to Integrate Data From Preexisting Cohort Studies Using the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model: Case Study

Keiichi Matsuzaki, Megumi Kitayama, Keiichi Yamamoto, Rei Aida, Takumi Imai, Mami Ishida, Ritsuko Katafuchi, Tetsuya Kawamura, Takashi Yokoo, Ichiei Narita, Yusuke Suzuki

JMIR Med Inform 2023 (Dec 21); 11:e46725

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Medical Extended Reality Trials: Building Robust Comparators, Controls, and Sham

Susan Persky, Luana Colloca

J Med Internet Res 2023 (Nov 22); 25:e45821

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The Roles of Electronic Health Records for Clinical Trials in Low- and Middle-Income Countries: Scoping Review

Jiancheng Ye, Shangzhi Xiong, Tengyi Wang, Jingyi Li, Nan Cheng, Maoyi Tian, Yang Yang

JMIR Med Inform 2023 (Nov 22); 11:e47052

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Methods for the Clinical Validation of Digital Endpoints: Protocol for a Scoping Review Abstract

Sílvia Rego, Ana Rita Henriques, Sofia Silvério Serra, Teresa Costa, Ana Maria Rodrigues, Francisco Nunes

JMIR Res Protoc 2023 (Oct 26); 12:e47119

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Internet-Based Recruitment and Retention of Young Adults With Type 1 Diabetes: Cross-Sectional Study

Stephanie Griggs, Garrett I Ash, Grant Pignatiello, AnnMarie Papik, Johnathan Huynh, Mary Leuchtag, Ronald L Hickman Jr

JMIR Form Res 2023 (Aug 22); 7:e46415

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Targeted Glioblastoma Treatment via Synthesis and Functionalization of Gold Nanoparticles With De Novo–Engineered Transferrin-Like Peptides: Protocol for a Novel Method

Augusto Müller Fiedler, Michelle Medeiros, Haidi Dalinda Fiedler

JMIR Res Protoc 2023 (Aug 11); 12:e49417

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Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study

Huichuan Tian, Yao Zhang, Jiajun Ren, Chaoran Wang, Ruiyu Mou, Xiaojiang Li, Yingjie Jia

JMIR Res Protoc 2023 (Aug 07); 12:e46794

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Reducing Clinical Trial Monitoring Resources and Costs With Remote Monitoring: Retrospective Study Comparing On-Site Versus Hybrid Monitoring

Zhiying Fu, Xiaohong Liu, Shuhua Zhao, Yannan Yuan, Min Jiang

J Med Internet Res 2023 (Jun 27); 25:e42175

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Establishing Requirements for Technology to Support Clinical Trial Retention: Systematic Scoping Review and Analysis Using Self-determination Theory

Eoin Gamble, Conor Linehan, Ciara Heavin

J Med Internet Res 2023 (Apr 13); 25:e38159

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Direct-to-Consumer Recruitment Methods via Traditional and Social Media to Aid in Research Accrual for Clinical Trials for Rare Diseases: Comparative Analysis Study

Janelle Applequist, Cristina Burroughs, Peter A Merkel, Marc Rothenberg, Bruce Trapnell, Robert Desnick, Mustafa Sahin, Jeffrey Krischer

J Med Internet Res 2023 (Mar 14); 25:e39262

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