Automated protocol templates with efficient schedule of activities table generation for healthy volunteer trials

This study introduces a novel automated protocol template generation process using <i>R Markdown</i> as the primary tool, with <i>Quarto</i> compatibility confirmed, and a web-based SoA generator designed specifically for healthy volunteer trials. By improving the efficiency and accuracy of clinical trial document preparation, these tools have the potential to advance the drug development process.

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Publication Details

Journal
Contemporary Clinical Trials Communications
Published
2025-05-24
DOI
https://doi.org/10.1016/j.conctc.2025.101498
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
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article

Automated protocol templates with efficient schedule of activities table generation for healthy volunteer trials

Seunghoon Han, Sungpil Han, Hyerim Choe, Seung-Ah Choi et al.
1 links
Contemporary Clinical Trials Communications
Statistical Methods in Clinical Trials
article

Automated protocol templates with efficient schedule of activities table generation for healthy volunteer trials

Seunghoon Han, Sungpil Han, Hyerim Choe, Seung-Ah Choi, Kwang-Sik Shin
article en

Abstract

This study introduces a novel automated protocol template generation process using <i>R Markdown</i> as the primary tool, with <i>Quarto</i> compatibility confirmed, and a web-based SoA generator designed specifically for healthy volunteer trials. By improving the efficiency and accuracy of clinical trial document preparation, these tools have the potential to advance the drug development process.

Contemporary Clinical Trials CommunicationsVol. 46
The Catholic University of Korea Seoul St. Mary's Hospital (KR), Korea Research Institute of Bioscience and Biotechnology (KR), Catholic University of Korea (KR)
Zero hunger
Openalex Percentile: Top 89%
Statistical Methods in Clinical Trials
DOIOpen Access PDFOpenAlex
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Automated protocol templates with efficient schedule of activities table generation for healthy volunteer trials — Seunghoon Han, Sungpil Han, et al. · Contemporary Clinical Trials Communications (2025) | TGRS Research Map | TGRS