This paper assessed some of the reported cases of building failures and their possible causes in Nigeria between 1977 and 2011. The reported major failure causes are structural failure (SF), Carelessness (CLSS), poor ...This paper assessed some of the reported cases of building failures and their possible causes in Nigeria between 1977 and 2011. The reported major failure causes are structural failure (SF), Carelessness (CLSS), poor workmanship (PW), poor supervision (PS), poor materials (PM), and quackery (Q).These causes of failure were subjected to Chi-Square statistical test at 5% significant level and 4 degree of freedom to know the most common cause of failure in Nigeria. The analysis showed quackery as the principal culprit in the reported building failures in Nigeria with prevalence of 8 over poor supervision being the minimum in occurrence. Structural failure occurred 5 times, while poor materials, carelessness and poor workmanship occurred 4, 2 and 2 respectively. The Council for the Regulation of Engineering in Nigeria (COREN) with Engineering Regulation and Monitoring (ERM) as her arm as a technical professional group discouraging quackery and failures generally in Engineering Practice. The holistic approach needs effective training of Engineers starting with strong mathematical and scientific background at the secondary and tertiary education levels in conjunction with rigorous field and Industrial training exercises. There after effective scrutiny, professional registration process of competent engineers is followed.展开更多
目的:梳理既往接受国家药品监督管理局食品药品审核查验中心(Center for Food and Drug Inspection of NMPA,CFDI)临床试验数据的现场核查情况,分析和探讨2020版《药物临床试验质量管理规范》(Good Clinic Practice, GCP)实施后,药物临...目的:梳理既往接受国家药品监督管理局食品药品审核查验中心(Center for Food and Drug Inspection of NMPA,CFDI)临床试验数据的现场核查情况,分析和探讨2020版《药物临床试验质量管理规范》(Good Clinic Practice, GCP)实施后,药物临床试验数据现场核查常见问题的关注点及要求,以期为临床试验的实施和管理提供参考。方法:收集本院自2015年7月22日以来接受CFDI数据现场核查的不合格情况,共计21个项目接受临床试验核查,不合格项135条。针对既往不合格项中的常见问题,分析2020版GCP和现场核查的关注点及要求。结果:既往不合格项主要集中在过程记录及检查检验数据溯源、方案执行、安全性事件记录、试验用药品的管理与记录、生物样品流通管理、相关数据链的完整性等方面。2020版GCP与现场核查要点对于临床试验数据现场核查常见问题与既往要求有较大差异。结论:在新形势下,需改变既往观念和规则,根据2020版GCP和药物临床试验数据现场核查的关注点及要求开展药物临床试验。展开更多
文摘This paper assessed some of the reported cases of building failures and their possible causes in Nigeria between 1977 and 2011. The reported major failure causes are structural failure (SF), Carelessness (CLSS), poor workmanship (PW), poor supervision (PS), poor materials (PM), and quackery (Q).These causes of failure were subjected to Chi-Square statistical test at 5% significant level and 4 degree of freedom to know the most common cause of failure in Nigeria. The analysis showed quackery as the principal culprit in the reported building failures in Nigeria with prevalence of 8 over poor supervision being the minimum in occurrence. Structural failure occurred 5 times, while poor materials, carelessness and poor workmanship occurred 4, 2 and 2 respectively. The Council for the Regulation of Engineering in Nigeria (COREN) with Engineering Regulation and Monitoring (ERM) as her arm as a technical professional group discouraging quackery and failures generally in Engineering Practice. The holistic approach needs effective training of Engineers starting with strong mathematical and scientific background at the secondary and tertiary education levels in conjunction with rigorous field and Industrial training exercises. There after effective scrutiny, professional registration process of competent engineers is followed.
文摘目的:梳理既往接受国家药品监督管理局食品药品审核查验中心(Center for Food and Drug Inspection of NMPA,CFDI)临床试验数据的现场核查情况,分析和探讨2020版《药物临床试验质量管理规范》(Good Clinic Practice, GCP)实施后,药物临床试验数据现场核查常见问题的关注点及要求,以期为临床试验的实施和管理提供参考。方法:收集本院自2015年7月22日以来接受CFDI数据现场核查的不合格情况,共计21个项目接受临床试验核查,不合格项135条。针对既往不合格项中的常见问题,分析2020版GCP和现场核查的关注点及要求。结果:既往不合格项主要集中在过程记录及检查检验数据溯源、方案执行、安全性事件记录、试验用药品的管理与记录、生物样品流通管理、相关数据链的完整性等方面。2020版GCP与现场核查要点对于临床试验数据现场核查常见问题与既往要求有较大差异。结论:在新形势下,需改变既往观念和规则,根据2020版GCP和药物临床试验数据现场核查的关注点及要求开展药物临床试验。
