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<p>Based on the literature and collective experience and consensus of the authors, this article provides a definition for an event-driven electronic diary (EDeD), outlines considerations for the use of EDeDs, and provides best practice recommendations for their design and implementation in clinical trials. This is a much-needed resource to optimize data quality in clinical trials and to support a necessary level of standardization using this form of data capture.</p>

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Best practice recommendations and considerations for designing and electronically implementing event-driven diaries in clinical trials

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月15日

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  • Florence D. Mowlem,
  • Jeremiah J. Trudeau,
  • Jill V. Platko,
  • Jos Bloemers,
  • Emuella Flood,
  • Jessica L. Abel,
  • Kelly Dumais,
  • Paul O’Donohoe,
  • Sabrina Grant,
  • Ryan Naville-Cook,
  • Onyekachukwu Illoh,
  • Shannon D. Keith,
  • Jing Ju,
  • Megan Fitter,
  • Dorothee Oberdhan,
  • Randall Winnette,
  • Manuela Bossi,
  • Naomi Suminski,
  • Sonya Eremenco,
  • Lindsay Hughes,
  • Amy Fasiczka,
  • Luisana Rojas,
  • Michelle Campbell,
  • Scottie Kern,
  • Jeremiah J. Trudeau

摘要

Based on the literature and collective experience and consensus of the authors, this article provides a definition for an event-driven electronic diary (EDeD), outlines considerations for the use of EDeDs, and provides best practice recommendations for their design and implementation in clinical trials. This is a much-needed resource to optimize data quality in clinical trials and to support a necessary level of standardization using this form of data capture.