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Best practice recommendations and considerations for designing and electronically implementing event-driven diaries
Florence D Mowlem1, Jeremiah J Trudeau2, Jill V Platko3
1uMotif, London, UK. florence.mowlem@umotif.com.
NPJ Digital Medicine
|December 16, 2025
Summary
This article defines event-driven electronic diaries (EDeDs) for clinical trials. It offers best practices for EDeD design and implementation to improve data quality and standardization.
Area of Science:
- Clinical Trials Methodology
- Health Informatics
- Data Management
Background:
- Electronic diaries are increasingly used in clinical trials.
- Standardization and best practices for event-driven electronic diaries (EDeDs) are lacking.
- Optimizing data quality is crucial for reliable clinical trial outcomes.
Purpose of the Study:
- To provide a clear definition of event-driven electronic diaries (EDeDs).
- To outline key considerations for utilizing EDeDs in clinical research.
- To establish best practice recommendations for EDeD design and implementation.
Main Methods:
- Literature review and synthesis of collective author experience and consensus.
- Development of a standardized definition for EDeDs.
- Formulation of practical recommendations for EDeD use in clinical trials.
Main Results:
- A comprehensive definition of event-driven electronic diaries (EDeDs) is presented.
- Considerations for the effective use of EDeDs are detailed.
- Evidence-based best practices for EDeD design and implementation are provided.
Conclusions:
- Standardized definitions and best practices for EDeDs are essential for clinical trials.
- Implementing these recommendations can enhance data quality and consistency.
- This resource supports the optimal use of EDeDs in clinical research settings.
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