ArticleJAMIA open2019
A new risk and issue management system to improve productivity, quality, and compliance in clinical trials.
Article in JAMIA open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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
10 citing papers in PubMed.
- Benefits and harms associated with the use of AI-related algorithmic decision-making systems by healthcare professionals: a systematic review.The Lancet regional health. Europe · 2025Article
- Is artificial intelligence for medical professionals serving the patients? : Protocol for a systematic review on patient-relevant benefits and harms of algorithmic decision-making.Systematic reviews · 2024Article
- Development of a risk assessment and risk management tool for an academic research organization.Contemporary clinical trials · 2022Article
- Article
- Clinical researchers' lived experiences with data quality monitoring in clinical trials: a qualitative study.BMC medical research methodology · 2021Article
- Massage Therapy for Fatigue Management in Breast Cancer Survivors: A Systematic Review and Descriptive Analysis of Randomized Controlled Trials.Evidence-based complementary and alternative medicine : eCAM · 2021Review
- Use of machine learning in geriatric clinical care for chronic diseases: a systematic literature review.JAMIA open · 2020Review
- Xcellerate Investigator Portal: A New Web-Based Tool for Online Delivery of Central Laboratory Data, Reports, and Communications to Clinical Sites.SLAS technology · 2020Article
- Role of Artificial Intelligence in Patient Safety Outcomes: Systematic Literature Review.JMIR medical informatics · 2020Review
- A cross-source, system-agnostic solution for clinical data review.Database : the journal of biological databases and curation · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWe present a new system to track, manage, and report on all risks and issues encountered during a clinical trial. MATERIALS AND
methodsOur solution utilizes JIRA, a popular issue and project tracking tool for software development, augmented by third-party and custom-built plugins to provide the additional functionality missing from the core product.
resultsThe new system integrates all issue types under a single tracking tool and offers a range of capabilities, including configurable issue management workflows, seamless integration with other clinical systems, extensive history, reporting, and trending, and an intuitive web interface. DISCUSSION AND
conclusionBy preserving the linkage between risks, issues, actions, decisions, and outcomes, the system allows study teams to assess the impact and effectiveness of their risk management strategies and present a coherent account of how the trial was conducted. Since the tool was put in production, we have observed an increase in the number of reported issues and a decrease in the median issue resolution time which, along with the positive user feedback, point to marked improvements in quality, transparency, productivity, and teamwork.
Indexed as
Identifiers
What 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.