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Analysis of quality control of clinical trials of in vitro diagnostic reagents
In recent years, with the rapid development of biomedical science and technology, new technologies and new methods have been widely used, and in vitro diagnostic reagents have developed and grown together with modern laboratory medicine. In vitro diagnostic reagent is an important means of clinical disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation, is an important basis for clinical medical research, an important part of modern laboratory medicine. The effectiveness and safety of in vitro diagnostic reagents used in clinical practice and guiding clinical treatment are confirmed through clinical trials, the last link of research and development. The data and results of the trials are an important basis for the approval and registration of drug regulatory authorities. At present, the quality management of drug clinical trials in China is becoming more and more standardized, and the monitoring is becoming more and more strict. The quality control of in vitro diagnostic reagents clinical trials according to the management of medical devices is very important to standardize the process of the test, improve the quality of the test, and obtain accurate, true and reliable clinical data.
In our country, in vitro diagnostic reagents are managed according to medical devices, but their own particularity is also very obvious, and their clinical trials are quite different from other medical devices and drug clinical trials. Combined with the State Food and Drug Administration issued in 2016 No. 98 circular annex 1 "in vitro diagnostic reagent clinical trial site inspection points" and our practical work experience, the key points of quality control in clinical trials of in vitro diagnostic reagents are discussed.
The quality control of clinical trials of in vitro diagnostic reagents involves qualification documents, approval documents, operational documents and original records.
The "Key Points for On-site Inspection of Clinical Trials of In Vitro Diagnostic Reagents" of biological samples requires original records of the source, number, preservation, use, retention and destruction of biological samples, and the completeness and originality of the records of each link can be traced. In our actual work, according to the provisions of the test plan, we focus on quality control from these aspects of the sample.
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