1.Development and application of core competence assessment index system among drug clinical trial quality control personnel
Yu CHEN ; Qingqing JIANG ; Guo YE ; Weiran MAO ; Yuanyuan YIN ; Mengjuan ZHANG ; Pu SUN ; Xia CHEN
China Pharmacy 2025;36(24):3023-3028
OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work, responsibilities, and role positioning of quality management personnel in drug clinical trials, a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions, ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions, comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%, with Kendall’s W coefficients of 0.256 and 0.277 (P<0.001 for both), and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators, covering individual professional competence, communication skills, implementation condition verification, informed consent process review, clinical trial execution monitoring, adverse event disposal, reporting and documentation, trial record examination, trial report auditing, and inspection of other tasks, and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents (P<0.05). Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice (GCP) requirements (0.34-point gap), familiarity with national and institutional clinical trial inspection priorities (0.24-point gap),etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies, highlighting the urgent need for targeted training programs to enhance their overall professional capabilities.
2.Hygienic status of central air conditioning ventilation systemsin public places in urban areas of Ma'anshan City
LI Yanyan ; WEI Hao ; ZHOU Yan ; WANG Li ; YE Mengjuan ; SUN Yuanting ; GAN Junying ; BIAN Qian
Journal of Preventive Medicine 2024;36(1):51-54
Objective:
To investigate the hygienic status of the central air conditioner ventilation system in public places in urban areas of Ma'anshan City, Anhui Province, so as to provide insights into formulation of supervision and management interventions.
Methods:
A total of 15 public places with the central air conditioner ventilation system were randomly sampled from main urban areas in Ma'anshan City in 2022. Sampling and detection were performed following the standard GB/T 18204.5—2013 Examination methods for public places Part 5: Central air conditioning ventilation system, including total number of bacteria and total number of fungus on the inner surface of wind pipes, total number of bacteria and fungus, particulate matter (PM10) and β-hemolytic streptococci in the air supply system, and Legionella pneumophila in the cooling water, and the detection indicators were assessed following the WS 394—2012 Guideline for hygiene of the central air conditioner ventilation system in public places. The eligible rate of samples, the detection rate of L. pneumophila were analyzed.
Results:
A total of 368 samples were collected from 15 public places, and the qualified rate was 50.54%, no places had all eligible measurement indicators. The qualified rates of total bacteria and fungus numbers on the inner surface of wind pipes were 52.67% and 59.33%. The qualified rates of total bacterium number, total fungus number, PM10 and β-hemolytic streptococci were 12.00%, 28.00%, 90.00% and 96.00% in the air supply system. The qualified rates of samples in administrative workplaces, hotels, bathing places and malls (supermarkets) were 32.50%, 59.24%, 61.09% and 68.92%, the qualified rates of total bacteria on the inner surface of air ducts were 8.33%, 72.46%, 66.67% and 61.90%, and the qualified rates of total fungus numbers in air supply were 0, 21.70%, 33.30% and 71.40%, respectively, with statistical significance (P<0.05). A total of 18 cooling water samples were collected, and L. pneumophila was detected in three samples (16.67%).
Conclusions
Poor hygiene is seen in the central air conditioning ventilation systems in public places in main urban areas of Ma'anshan City. High attention needs to be paid to contamination of bacterium, fungus and L. pneumophila, and expansion of supervision coverage and improved supervision intensity are recommended.
3.Construction of pediatric bone and joint system diagnostic imaging online course by blackboard platform
Miao FAN ; Youyou YANG ; Mengjuan HUO ; Junli WANG ; Ziping LI ; Jianyong YANG ; Binbin YE ; Quanfei MENG
Chinese Journal of Medical Education Research 2012;11(1):49-52
Diagnostic Imaging Pediatric bone and joint system was a sub-branch of professional courses.The content was more difficult and learners were not relaxed to master the knowledge alone.It was easy,across time and space,resource sharing and interactive to operate on blackboard teaching platform.We can better accomplish teaching and learning task with pediatric bone and joint diagnostic imaging online course constructed by blackboard platform.
4.Metabonomic study of intervention effects of Morinda officinalis on 'kidney-yang deficiency syndrome'.
Mengjuan GONG ; Wenhua YE ; Yuanyuan XIE ; Shumei WANG ; Shengwang LIANG ; Zhongjie ZOU
China Journal of Chinese Materia Medica 2012;37(11):1682-1685
OBJECTIVETo investigate the metabolic profile of hydrocortisone-induced 'Kidney-yang deficiency syndrome'in rats and the intervention effects of Morinda officinalis.
METHODProton nuclear magnetic resonance (1H-NMR) technique was used to analyze the rat metabonome in serum. Orthogonal partial least squares discriminant analysis (OPLS-DA) were processed to analyze the metabonome difference between the control and hydrocortisone treated samples. Twelve potential biomarkers were selected, via the parameter of variable importance in the projection (VIP). Principal components analysis (PCA) was employed to process the data from the M. officinalis. treatment group and the intervention effects of M. officinalis, was investigated through the selected potential biomarkers.
RESULTAfter hydrocortisone treatment, the energy metabolism, amino acids metabolism and gut microflora environment were seriously disturbed and transmethylation was surpressed. M. officinalis could effectively alleviate the disturbance of energy and amino acids metabolism and enhance transmethylation, but could not modulate the gut microflora environment.
CONCLUSIONThe results obtained suggested that metabonomic studies could better reflect the whole status of metabolism in bio-systems, and could be treated as a potential powerful approach in pharmacological studies and investigation of the essence of 'syndrome' in traditional Chinese medicine.
Animals ; Biomarkers ; metabolism ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Kidney ; drug effects ; metabolism ; Male ; Metabolomics ; Morinda ; chemistry ; Rats ; Rats, Sprague-Dawley ; Yang Deficiency ; drug therapy ; metabolism


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