ArticleJournal of the American Medical Informatics Association : JAMIA
Developing regulatory-compliant electronic case report forms for clinical trials: experience with the demand trial.
Article in Journal of the American Medical Informatics Association : JAMIA. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed.
- Glomerular resistances predict long-term GFR decline in type 2 diabetic patients without overt nephropathy: a longitudinal subgroup analysis of the DEMAND trial.Acta diabetologica · 2022Trial
- Data Management 101 for drug developers: A peek behind the curtain.Clinical and translational science · 2023Review
- An Electronic Data Capture Framework (ConnEDCt) for Global and Public Health Research: Design and Implementation.Journal of medical Internet research · 2020Article
- Guidelines for Data Acquisition, Quality and Curation for Observational Research Designs (DAQCORD).Journal of clinical and translational science · 2020Article
- Improving the Efficacy of the Data Entry Process for Clinical Research With a Natural Language Processing-Driven Medical Information Extraction System: Quantitative Field Research.JMIR medical informatics · 2019Article
- Secure and Scalable mHealth Data Management Using Blockchain Combined With Client Hashchain: System Design and Validation.Journal of medical Internet research · 2019Article
- Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology.British journal of clinical pharmacology · 2017Review
- Use of the data system for field management of a clinical study conducted in Kolkata, India.BMC research notes · 2016Article
- Constitutional multicenter bank linked to Sasang constitutional phenotypic data.BMC complementary and alternative medicine · 2015Article
- Experience of using an open source clinical trials data management software system in Kenya.BMC research notes · 2014Article
- Understanding the global epidemiology of pediatric critical illness: the power, pitfalls, and practicalities of point prevalence studies.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2014Review
- [Database supported electronic retrospective analyses in radiation oncology: establishing a workflow using the example of pancreatic cancer].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2012Article
- HIS-based Kaplan-Meier plots--a single source approach for documenting and reusing routine survival information.BMC medical informatics and decision making · 2011Article
- IT Infrastructure Components for Biobanking.Applied clinical informatics · 2010Article
- Data sharing: A viable resource for future.Perspectives in clinical researchReview
- Paperless clinical trials: Myth or reality?Indian journal of pharmacologyReview
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
The use of electronic case report forms (CRF) to gather data in randomized clinical trials has grown to progressively replace paper-based forms. Computerized form designs must ensure the same data quality expected of paper CRF, by following Good Clinical Practice rules. Electronic data capture (EDC) tools must also comply with applicable statutory and regulatory requirements. Here the authors focus on the development of computerized systems for clinical trials implementing FDA and EU recommendations and regulations, and describe a laptop-based electronic CRF used in a randomized, multicenter clinical trial.
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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.