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seccr was officially transformed from “planned” to “established”
on 21 february 2019, shanghai municipal health commission approved to establish “shanghai ethics committee for clinical research”(seccr), which meant the official establishment of seccr.
in accordance with opinions on deepening the reform of the examination and approval system to encourage innovation in pharmaceuticals and medical devices, issued by general office of the cpc central committee and general office of the state council on 8 october 2017, shanghai ethics committee for clinical research (planning), based on the 9 years’ operation of independent ethics committee of scrc was approved to be built by former shanghai municipal health and family planning commission on 8 december 2017 and officially unveiled on 8 february 2018. on the basis of about one year’s planning undertaken, seccr (planning) witnessed all-round development in organization and management, compliance with regulations and standard operating procedures, review procedures and quality, conduction of follow-up review, documentation and record storage, etc. according the opinions on deepening the reform of the examination and approval system to encourage innovation in pharmaceuticals and medical devices implemented by general office of shanghai municipal committee and municipal general office on 7 november 2018, shanghai municipal health commission organized experts in the relevant fields to hold an experts meeting.
in the future days, shanghai ethics committee for clinical research would follow the approval document of shanghai municipal health commission, and also rely on scrc on the basis of co-construction by shanghai municipal health commission and xuhui district people’s government to further improve the construction of relevant regulations and sop, to explore the means and mode of third-party ethics committee. moreover, it aimed to constantly carry out internal capacity building, intensify training on review capacity of the committee, promote unified normalization of ethic review and capacity elevation, and to practically strengthen efficiency. in addition, seccr would spare no efforts to make its contribution in terms of ethic review, service channel and social responsibility. focused on coordination with ethics committee of the institutions, it would play its leading role in impelling cooperation and communication in yangtze river delta as well as the advanced and integrated development of the delta under seizing-the-day spirit. |
