Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 4, 2025
Date Accepted: Nov 19, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A systematic review protocol of frameworks for guiding the selection of digital data collection tools used in clinical trials
ABSTRACT
Background:
Data collection is an essential aspect of clinical trials, as it forms the basis of the scientific analysis that evaluates the performance and safety of interventions. With the wide variety of digital data collection tools available, decision-makers responsible for choosing the appropriate tools for clinical trials must exercise caution. There are numerous challenges that could impact data collection, and careful selection is necessary to ensure the tools effectively support the trialClick or tap here to enter text. Therefore, an evidence-based framework is needed to support the selection of an appropriate digital data collection tool in clinical trials.
Objective:
This systematic review aims to develop an evidence-based framework for the selection of digital data collection tools for clinical trials.
Methods:
Bibliographic databases including IEEE Xplore, eAIS, PubMed, CINAHL, Medline, Embase, Clinical Trial.Gov, Scopus and Web of Science will be searched for published articles. Additionally, searches will be performed for publicly available grey literature from reputable institutions such as the United States Food and Drug Administration (FDA) and World Health Organization (WHO). Studies should include a framework that is relevant to selecting digital data collection tools for clinical trials. Two reviewers will independently use CovidenceTM to screen and review articles to be included. Data relating to the selection of digital data collection tools will be extracted. Thematic synthesis will be conducted to develop a new evidence-based framework for selecting digital data collection tools for clinical trials.
Results:
The searches yielded 9151 studies which was reduced to 4333 after the removal of duplicates in CovidenceTM.
Conclusions:
There is a dearth of established frameworks to guide the selection of digital data collection tools for clinical trials. This review aims to develop an evidence-based framework to support technology decision-makers in identifying and selecting tools that are fit-for-purpose, ensuring they meet the specific needs of clinical research settings. Clinical Trial: https://www.crd.york.ac.uk/PROSPERO/view/CRD420250612895
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Copyright
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