Frameworks for Guiding the Selection of Digital Data Collection Tools Used in Clinical Trials: Protocol for a Systematic Review.

Background: Data collection is an essential aspect of clinical trials because 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 a careful selection of tools is necessary to ensure that they effectively support the trial. 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, ClinicalTrials.gov, Scopus, and Web of Science will be searched for published articles. Additionally, searches will be performed for publicly available gray literature from reputable institutions such as the United States Food and Drug Administration and World Health Organization. Studies should include a framework that is relevant to selecting digital data collection tools for clinical trials. Two reviewers will independently use Covidence to screen and review the articles to be included. Data related to the selection of digital data collection tools will be extracted. Thematic synthesis will be conducted to develop a new evidence-based framework to select digital data collection tools for clinical trials. Results: The review started in May 2025 and is expected to be completed in December 2025. The searches yielded 9151 studies, which were reduced to 4333 after the removal of duplicates using Covidence. 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.