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Use case and application requirements for a protocol lifecycle tracking tool, with a focus on the trial initiation
Jack W London1, Sharon A Elcombe, Alma Villasin
1Thomas Jefferson University, Philadelphia, PA;
Summary
Streamlining clinical trial initiation is crucial for research progress. A new Protocol Lifecycle Tracking (PLT) tool aims to improve efficiency by managing workflows and identifying bottlenecks in the trial startup process.
Area of Science:
- Clinical Research Operations
- Health Informatics
- Biomedical Research Management
Background:
- Clinical trial initiation timelines are excessively long, significantly impeding research progress.
- Operational efficiency improvements are hindered by complex workflows and diverse trial/institutional settings.
Purpose of the Study:
- To develop use cases and system requirements for a Protocol Lifecycle Tracking (PLT) tool.
- To enhance the management and monitoring of clinical trial initiation processes.
Main Methods:
- Defined use cases for a Protocol Lifecycle Tracking (PLT) tool.
- Specified system requirements for PLT application development.
Main Results:
- A comprehensive use case document was created.
- This document serves as the foundational specifications for developing a PLT application.
Conclusions:
- A Protocol Lifecycle Tracking (PLT) tool can significantly improve clinical trial initiation efficiency.
- The developed use cases and requirements provide a roadmap for creating a functional PLT application to aid study staff and stakeholders.
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