ArticleTherapeutic innovation & regulatory science2026
Use of Information Technology to Mitigate Protocol Deviations in Clinical Research: A Quality Improvement Project.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAccurate vital sign (VS) documentation is essential in clinical research to ensure participant safety and data integrity. However, protocol deviations related to VS transcription and documentation remain a persistent challenge. This quality improvement project aimed to reduce VS-related protocol deviations through the implementation of monitor integration (MI) technology on an inpatient clinical research unit at an urban academic medical center. MATERIALS AND
methodsGuided by Lewin's Change Management Model, the intervention included structured educational sessions for 31 clinical research nurses (CRNs), emphasizing protocol adherence, the use of MI to reduce documentation errors, and hands-on MI training. Peer support champions were designated to provide bedside guidance. A two-week audit compared VS-related protocol deviation rates from 451 pre-intervention and 682 post-intervention research visits.
resultsFollowing implementation, VS-related protocol deviations decreased significantly from 2.7% to 0.3% (p < 0.001). Nurse adoption of MI improved through targeted education and peer support, promoting alignment with Good Clinical Practice (GCP) guidelines and enhancing workflow efficiency. DISCUSSION: The combination of MI technology, training, and peer mentorship successfully reduced documentation errors and improved data quality. Despite initial resistance, CRNs adopted a new process, demonstrating the value of integrating technology into clinical workflows. Limitations include a short intervention period and the study's single institution setting.
conclusionMI technology, when paired with education and peer support, can reduce VS-related protocol deviations and strengthen research compliance. These findings support broader adoption of MI in clinical research settings and underscore the importance of continued investment in CRN education and health technology integration.
Indexed as
Identifiers
41865155What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.