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For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
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Humans , Asian People , Australia , Canada , Caribbean Region , Developed Countries , Emigration and Immigration , European Union , Japan , Korea , Licensure , Nurses, International , Nursing , United StatesABSTRACT
Objective To explore the possibility and reliability of mutual recognition of renal indexs among 20 clinical labora-tories entitled with state key clinical laboratory,and to supply reference for future national mutual recognition of laboratory examination results.Methods Determined the concentrations of TP,ALB,TC,TG and Roche multiple calibrators and sub-mitted the results.The results were analyzed for robust Z score,percentage difference after calibration,bias at medical deci-sion level to observe the possibility and reliability.Results The bias of TG was out of the least allowable bias,thus they were not appropriate to mutual recognition.Conclusion It remains immature in the mutual recognition of lipids’determina-tions and much work needs to be done in field of internal quality control of the laboratory.
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Objective To discuss the feasibility of enzymatic reference methods in Routine Chemistry external quality assessment (EQA)inlaboratorymedicine.Methods Samplesofthe1stEQAin2012byNationalCenterforClinicalLaboratories(NCCL)and patients′sera were measured by reference methods and 5 clinical analytic systems for the catalytic activity of CK ,LDH ,ALP ,ALT , AST ,GGT and AMY ,then the results of 5 clinical systems were compared with the reference methods′or target value of NCCL by calculating the bias ,and evaluated them according to the criteria of EQA by NCCL .Results The results of EQA samples measured by reference methods was within ± 10% compared with NCCL target value .Compared with the results of reference method ,the through put was 100 .0% for wet clinical chemistry systems measuring both EQA samples and patients′serum ,and the dry clinical chemistry systems was 77 .1 for EQA samples and 97 .1% for patients′serum according to the criterion of EQA ,and the through put was 72 .9% and 63 .6% of wet clinical chemistry systems according to the standard of enzymatic trueness of NCCL .Conclusion Reference method could be applied to EQA ,and will be a great help for the trueness of clinical testing .
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Discussion on movement of medical personnel arises as a main issue when contracting free trade agreement between two countries. It is sensitive issue for both developed and developing country in terms of their own interest; developed country requires movement of medical personnel in order to solve aging population and manpower shortage problems in certain medical fields, whereas developing countries approache this issue with the purpose of exporting health professionals and improving the quality of medical care. We have not settled mutual recognition for medical professional's license, including that of medical doctors in Free Trade Agreement. However, as the opening of service sector expands is gradually, labor exchange of medical professionals at international level is expected to be more active in the future. Therefore, preparing quality of license at developed countries' standards and post management system is urgently required. Also, we have to strive for modification of law as well as global-level qualification to assist domestic professionals to enter overseas market.
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Aging , Contracts , Developed Countries , Developing Countries , Health Occupations , Jurisprudence , LicensureABSTRACT
A agroindústria familiar rural surge como uma alternativa na busca de novos nichos de mercados, utilizando-se da maior diversidade de produtos e da diferenciação dos produtos através da transformação dentro da propriedade. Sua implantação é considerada uma alternativa eficaz como política de Desenvolvimento Rural, mas, com todos os esforços, existem muitas limitações neste setor, principalmente da legislação sanitária. A construção dos mercados e das regras que os regem, mesmo com o cumprimento das normas legais, vem de dentro do processo e com a colaboração de todos os atores: produtores, consumidores. A Teoria das Convenções baseia-se no reconhecimento mútuo e coletivo da qualidade ampla do produto e foi utilizada para explicar como funcionam as interações entre produtores da Região Metropolitana de Porto Alegre com relação às regras de produção ou "modos de fazer" no processo produtivo.
The rural familiar agroindustry is an alternative in the search for new niche markets, using the greater diversity of existing products and product differentiation by transforming them inside the property. Its implementation is considered an effective alternative as policy of Rural Development, but despite all efforts there are many limitations in this sector especially in sanitary legislation. Quality is built on the agroindustries by looking not only at a physical process, but also relying on social and cultural aspects, considering personal efforts in making the products, dedication, tradition and artisanal "ways to make", which bring the colonial touch. The Theory of the Convention is based on mutual recognition and collective of wide quality of the product, and was used to explain how interactions are worked among producers at Metropolitan Porto Alegre Area regarding production rules or "ways to make" the production process.
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BACKGROUND: The use of Cooperative Institutional Review Board (Co-IRB) has become subject to continuous discussion. As a result, leading mainly by the Korea Association of Institutional Review Boards (KAIRB), "IRB mutual recognition program (MR-IRB)" was proposed. However operational methods of the program are still controversial. The object of this research is to examine domestically feasible scope and operation methods of MR-IRB by conducting survey. METHODS: 71 survey data was collected from chairman or specialist of each IRB and 29 IRB members of one institution running Central IRB was included. RESULTS: 76.5 % of respondents selected phase 3 multi-national, multi-center clinical Sponsor Initiated Trial as a suitable subject of MR-IRB, but only 50 % supported Investigator initiated trials, and answered early-stage clinical trials such as phase 1 clinical trials or biological agent trials are unsuitable due to relatively insufficient knowledge on risk level. In order to operate MR-IRB, standardized review criteria and agreement of institutions in building mutual trust is essential. Also it was learned from the survey that the most desirable way to adopt MR-IRB is to be initiated by the representing organization such as KAIRB based on mutual trust from institutional agreement. CONCLUSION: MR-IRB was recognized as one of Co-IRB. A suitable subjects of MR-IRB were preferred the phase 3 multi-national, multi-center clinical sponsor initiated trials to all kinds of clinical trials. This study suggests that based on real operation experience from MR-IRB pilot study, further study should be conducted to analyze pros and cons of MR-IRB and identify domestically eligible model to facilitate MR-IRB.