ArticleTherapeutic innovation & regulatory science2025
Research on Core Competency Elements of Clinical Investigators.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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
2 citing papers in PubMed.
- Bridging the gap in clinical research training: a qualitative study of postgraduate medical students' perceptions of good clinical practice education.Medical education online · 2026Article
- Beyond GCP: developing a differentiated competency framework for principal investigators in innovative drug clinical trials in China.Frontiers in medicine · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundTo construct a competency model for clinical investigators involved in the process of new drug development, providing a reference for the training, selection and assessment of clinical investigators.
methodsThe Behavioral Event Interview (BEI) method was used to interview 12 excellent clinical investigators and 8 clinical investigators of average performance. Each competency characteristic was extracted from the interview text by semantic coding. Total frequency, total score, average score and highest score were calculated for each competency element. Category agreement coefficient, coefficient of reliability and Spearman correlation coefficient were used to assess the consistency of two coders for coding and classification. Independent-samples Mann-Whitney U test was applied to compare the differences in competency elements between the group of excellent clinical investigators and the group of average investigators.
resultsThe average coefficient of category agreement was 0.671, and the average coefficient of reliability was 0.803. No significant differences were observed between the two groups in the aspect of interview time (P = 0.190) and the interview words (P = 0.184), indicating comparability between the two groups. However, there was a clear performance difference between the excellent and average groups. In addition, we found that the competency model for clinical investigators contained 24 prominent competence elements and 8 benchmark competency elements.
conclusionsClinical investigator is a medical professional who is involved in a highly research-intensive and practical job, where prominent competency element largely reflects clinical practice skills, innovation and awareness of Good Clinic Practice (GCP). Our results provide a reference for assessing clinical investigators' competencies, encouraging and guiding them to modify their behaviors according to the competency model, and also cultivating clinical investigators so as to improve the competence level of clinical investigators.
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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.