1.Basic considerations during outsourcing of clinical data management services.
Acta Pharmaceutica Sinica 2015;50(11):1493-1497
With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
Clinical Trials as Topic
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Data Collection
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methods
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Information Storage and Retrieval
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methods
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Outsourced Services
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Quality Control
2.Investigation on Interpersonal Communication of Preparatory Students in One Xinjiang Medical College
Chinese Medical Ethics 2017;30(5):626-629
Objects:To investigate the current situation of interpersonal communication inpreparatory students in one Xinjiang medical college from the exchanges between students.Methods:Using self-developed questionnaire,a survey was conducted among 200 preparatory students and depth interviews were conducted for typical cases.Results:Preppies showed a strong willing of interpersonal communication.In the process of students' interaction,some features were presented as followings:pure motives but dissimilarity,narrow range of interactions,lack of interaction ability and the single form of social activities.Conclusion:Based on the above current situation of interpersonal communication in preparatory students,it should enhance the language application ability of preparatory stage,change the idea and attach importance to the education of humanistic quality in preparatory education and train preppy's expression and listening art.
3.Innovation Research and Practical Application of Critical Values Monitor in Medical Security Alert System
Chinese Medical Equipment Journal 1989;0(02):-
Objective The application of modern information technology to manage critical values of clinical examination,in order to improve the management level of patients safety and reduce the medical risk.Methods The critical values reminder in medical security alert system is developed and applied,the core module of the system are warning monitor of equipment record and SMS warning monitor of alerting in testing critical value.Results Through the application of system,the information of testing critical values are obtained duly,comprehensively and accurately,the notification time of clinical testing critical values are abbreviated,the notification scopes are spread and achieved the management of critical value at different levels.Conclusion The application of the system can be perfected the management of critical values,ensured patients safety,improved the medical quality and enhanced the management level of hospital,and then the system has become another example of informationization creating value.
4.Basic considerations during outsourcing of clinical data management services.
Acta Pharmaceutica Sinica 2015;50(11):1493-7
With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
6.Expression of ?-catenin in Human Carcinomas of Alimentary System and its Significance
Liang HAN ; Shiqiang SHEN ; Shilun TONG
Journal of Chinese Physician 2001;0(09):-
Objective To study the significance of ?-catenin expression in human gastric carcinomas, colorectal carcinomas and human hepatic carcinomas.Methods S-P immunohistochemical method was used to detect ?-catenin expression in 80 cases of human carcinomas of alimentary system and corresponding tumor-adjacent normal tissues by ?-catenin polyclonal antibody. The results were analyzed using densitometrically semiquantitated .Results ?-catenin were normally expressed in all tumor-adjacent normal tissues of digestive system. ?-catenin expression was reduced or negative in human carcinomas of alimentary system (P
7.Retinal detachment due to ocular contusion
Liping SHEN ; Yuming LI ; Jianping TONG
Chinese Journal of Ocular Fundus Diseases 1996;0(01):-
Objective To find out about the characteristics and prognosis of retinal detachment due to ocular contusion. Methods The clinical data of 36 patients (36 eyes) with retinal detachment due to ocular contusion were retrospectively analyzed. Results There were 3 eyes (8.3%) with huge retinal hole (≥90?), 4 eyes (11.1%) oral tear of ora serrata retinae, 4 eyes (11.1%) with macular hole, 3 eyes (8.3%) with tractive retinal detachment, and 22 eyes (61.2%) with retinal hole (
8.Study on the mechanism of diabetic nephropathy in type 2 diabetes mellitus of blood glucose fluctuation and oxidative stress
Ying JIN ; Linping TONG ; Peihong SHEN
Chinese Journal of Primary Medicine and Pharmacy 2017;24(13):1954-1958
Objective To study the mechanism of diabetic nephropathy(DN) in type 2 diabetes mellitus of blood glucose fluctuation and oxidative stress.Methods 90 patients with type 2 DN were selected,included 30 cases of the normal albuminuria (DM group),30 cases of microalbuminuria (NA group),30 cases of the mass albuminuria (MA group),and during the same period,30 healthy persons in our hospital for medical examination were selected as the control group(NC group).The blood glucose,blood lipid,blood glucose fluctuation and oxidative stress were compared among the 4 groups.Results The blood glucose(FBG),postprandial 2h blood glucose(2hPG),glycosylated hemoglobin(HbA1c) levels had statistically significantly differences among the 4 groups(F=23.088,24.356,43.553,all P<0.05),which in the NC group[(4.03±1.12)mmol/L,(7.11±1.41)mmol/L,(4.11±0.83)%]were lower than the other 3 groups[DM group:(6.34±1.48)mmol/L,(9.13±1.52)mmol/L,(6.67±1.24)%;NA group:(6.58±1.53)mmol/L,(9.78±1.79)mmol/L,(7.53±1.51)%;MA group:(6.84±1.71)mmol/L,(10.23±1.36)mmol/L,(8.11±2.02)%](F=23.088,24.356,43.553,all P<0.05).There were no statistically significant differences in total cholesterol(TC),three acyl glycerin(TG),high density lipoprotein cholesterol(HDL-C) and low density lipoprotein cholesterol(LDL-C) among the 4 groups(F=1.079,1.732,0.358,1.428,all P>0.05).The mean amplitude of glycemic excursions(MAGE),mean absolute value of blood glucose(MODD),superoxide dismutase(SOD) and malondialdehyde(MDA) levels in the 4 groups had statistically significant differences(F=37.350,216.899,21.003,93.211,all P<0.05).Correlation analysis showed that in patients with type 2 DN,negative correlation was observed between SOD and MAGE and MODD(r=-0.430,-0.523,all P<0.05),MDA and MAGE,MODD was positively correlated(r=0.534,0.624,all P<0.05).Conclusion Blood glucose fluctuation is involved in the occurrence and development of DN,the mechanism may be correlated with oxidative stress.
9.Study on Professor Wang Kungen's Therapeutic Principles in Treating Functional Dyspepsia Based on Data Mining
Shuhua SHEN ; Hongxuan TONG ; Kungen WANG
Journal of Zhejiang Chinese Medical University 2014;(10):1159-1162
Objective]To study Professor Wang Kungen's therapeutic principles in treating functional dyspepsia by data mining therapy. [Method]First, establish Wang Kungen's medical records database;then do data standardization and data mining.[Result]There are total y 408 cases that meet the demand. Postprandial distress syndrome is the major subtype of senile group while epigastric pain syndrome is the major subtype of non senile group. The major patterns of syndrome of FD in Professor Wang Kungen's medical records are as fol ows: liver qi attacking the stomach, deficiency and stagnation of spleen Qi, disharmony of stomach qi, stagnation of qi and accumulation of dampness, phlegm-heat harassing the inner body. The major prescriptions are as fol ows:ErChen Decoction, ZuoJin Pil s, SiJunZi Decoction, SiNi Powder, LiuJunZi Decoction, XiangSu Decoction, WenDan Decoction. There is close correlation between prescriptions and patterns as fol ows:liver qi attacking the stomach and SiNi Powder, ZuoJin Pil s;stagnation of qi and accumulation of dampness and ErChen Decoction,PingWei powder;phlegm-heat harassing the inner body and WenDan Decoction, ErChen Decoction; There is close correlation between herbs as fol ows: Processed Rhizoma Pinel iae and Tangerine Peel, Processed Rhizoma Pinel iae and Poria cocos; Rhizoma Coptidis and Processed Evodia rutaecarpa; Fructus Aurantii and Processed Mangnolia officinalis; Radix Bupleuri and Radix Paeoniae Alba; Poria cocos and Atractylodes;Tangerine Peel and Caulis Peril ae; Poria cocos and Codonopsis pilosula; Radix Bupleuri and Curcuma aromatica. [Conclusion]The incidence and subtype of FD between female group and male group is different. Professor Wang Kungen's therapeutic principles in treating FD are clearing liver and adjusting stomach, soothing liver-qi stagnation,harmonizing stomach and lowering adverse qi, promoting the circulation of qi and resolving dampness and clearing phlegm heat.