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Frameworks for Guiding the Selection of Digital Data Collection Tools Used in Clinical Trials: Protocol for a
Bavatharani Ananthesayanan1, Kayode Philip Fadahunsi2, Huanhuan Xiong1
1Department of Business Information Systems, University College Cork, College Road, Cork, T12K8AF, Ireland, 353 (021) 490 3000.
JMIR Research Protocols
|January 22, 2026
Summary
Selecting digital data collection tools for clinical trials is crucial for reliable results. This systematic review develops an evidence-based framework to guide decision-makers in choosing appropriate digital tools for clinical research.
Area of Science:
- Clinical research methodology
- Health informatics
- Data management in clinical trials
Background:
- Data collection is fundamental to clinical trial analysis, impacting intervention evaluation.
- Selecting appropriate digital data collection tools is challenging due to numerous potential pitfalls.
- An evidence-based framework is needed to guide the selection of digital tools for clinical trials.
Purpose of the Study:
- To develop an evidence-based framework for selecting digital data collection tools in clinical trials.
- To support decision-makers in choosing tools that are fit-for-purpose for clinical research.
Main Methods:
- Systematic review of bibliographic databases and gray literature.
- Inclusion of studies with frameworks relevant to digital data collection tool selection.
- Thematic synthesis of extracted data to develop the framework.
Main Results:
- Searched 9151 studies, reduced to 4333 after duplicate removal.
- Identified a lack of established frameworks for selecting digital data collection tools.
- Initiated review in May 2025, expected completion December 2025.
Conclusions:
- Established frameworks for digital data collection tool selection in clinical trials are scarce.
- The developed framework will aid technology decision-makers in selecting suitable tools.
- Ensuring tools meet specific clinical research needs is paramount.
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