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find Keyword "标准操作规程" 3 results
  • 药物临床试验中的几个重要环节

    我国对新药临床研究有严格的审批制度。临床试验以前,需要一系列有关药学、药效、毒理、动物药代动力学等试验结果和文献资料为药物进入临床研究提供充分的理由和依据,保证进入临床试验时受试者得到最大的效益,并将可能遇到的风险降到最低限度,最大程度保护受试者的权益。安全和健康必须高于对科学和社会利益的考虑,因此规范的临床试验尤为重要。这就要求临床试验的各个环节都必须按照标准操作规程进行,且在科学与伦理道德两方面都合格,既要保护受试者的权益,又要保证其安全。

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  • Application of BenchMark automatic special staining instrument in reticular fiber staining of liver biopsy

    ObjectiveTo explore the dyeing conditions of reticular fiber staining of liver puncture tissue stained by BenchMark automatic special staining instrument, evaluate the staining effect, and share the using experience.MethodsA total of 30 cases of liver puncture specimens from April to May 2019 in West China Hospital of Sichuan University were selected. They were fixed with 4% neutral formaldehyde fix solution, treated with automatic dehydrator, embedded in paraffin, stained with adhesive slides, and baked in 65℃ oven for 30 min. Each specimen was sliced in duplicate, with a thickness of 5 μm. One was reticular fiber stained with BenchMark automatic special staining instrument under the dyeing condition according to the using experience of the laboratory, and the other was reticular fiber stained by manual Foot staining method according to the standard operating procedure of the laboratory. The staining effect under microscope was observed by a chief pathologist with extensive slide-reading experience.ResultsThe success rate of instrumental method was 100.0% (30/30), and that of the manual method was 76.7% (23/30). The difference in success rate between the two methods was statistically significant (χ2=5.143, P=0.023).ConclusionThe reticular fiber staining effect of BenchMark automatic special staining instrument is stable and reliable, and the success rate is higher than that of manual Foot staining.

    Release date:2020-10-26 03:00 Export PDF Favorites Scan
  • Discussion of the process of conducting an investigator-initiated research

    The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.

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