Good Clinical Practice Q&As

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Good Clinical Practice Q&As

机译：良好的临床实践问答

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Monitors and auditors need to verify that information relevant to a clinical study in the source documents exists, may be reviewed, and have been verified. If such data is in an institution’s electronic medical files, some arrangement needs to be made for the monitor to access the records to determine that it has been accurately and completely included as part of study data. How that access is provided is up to the institution. If an institution is willing to allow the access you describe, they need to have processes in place to ensure the confidentiality of the patient data contained therein. The FDA instructs its field investigators to ask a member of the study staff to access the data so they are able to view it and then request hard copies of any sections that they need to include in their inspection report. They strongly discourage their inspectors from actually accessing the medical files themselves.

机译：监控人员和审计人员需要验证原始文档中与临床研究相关的信息是否存在，可以进行审查并已得到验证。如果此类数据在机构的电子医疗文件中，则需要进行一些安排，以使监控器可以访问记录，以确定其已被准确，完整地包含在研究数据中。如何提供访问权限取决于该机构。如果机构愿意允许您描述的访问权限，则他们需要制定流程来确保其中包含的患者数据的机密性。 FDA指示其现场调查人员要求研究人员访问数据，以便他们能够查看数据，然后索取需要包括在检验报告中的任何部分的纸质副本。他们强烈劝阻其检查员自己实际访问医疗文件。

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《Journal of Clinical Research Best Practices》 |2019年第8期|共1页
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中图分类临床医学;
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6. Mediation effects of clinical practice stress between clinical education environment and satisfaction with clinical practice [O] . Youngsoon Park, Kyunghee Chun, Mihye Kwon 2021

机译：临床教育环境与临床实践满意度临床实践压力的调解作用
7. ACC/AHA/ASNC Guidelines for the Clinical Use of Cardiac Radionuclide Imaging—Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging)44The ACC/AHA Task Force on Practice Guidelines makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or personal interest of a member of the writing panel. Specifically, all members of the writing panel are asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the parent task force, reported orally to all members of the writing panel at the first meeting, and updated as changes occur.55This document was approved by the American College of Cardiology Foundation Board of Trustees in July, 2003, the American Heart Association Science Advisory and Coordinating Committee in July, 2003, and the American Society of Nuclear Cardiology Board of Directors in July, 2003.66When citing this document, the American College of Cardiology Foundation, the American Heart Association, and the American Society of Nuclear Cardiology request that the following citation format be used: Klocke FJ, Baird MG, Bateman TM, Berman DS, Carabello BA, Cerqueira MD, DeMaria AN, Kennedy JW, Lorell BH, Messer JV, O’Gara PT, Russell RO Jr, St. John Sutton MG, Udelson JE, Verani MS, Williams KA. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging—executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Radionuclide Imaging). J Am Coll Cardiol 2003;42:1318–33.77(J Am Coll Cardiol 2003;42:1318–33)88©2003 by the American College of Cardiology Foundation and the American Heart Association, Inc. [O] . Klocke Francis J, Baird Michael G, Lorell Beverly H, 2003

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8. Innovative Development of Evidence-Based, Medical Evacuation Clinical Practice Guidelines and Novel Validation of the Current Critical Care Air Transport Team Clinical Practice Guideline. [R] . Petro, M., Rodriquez, D., Fowler, J., 2018

机译：基于证据的医疗后送临床实践指南的创新发展和当前重症监护航空运输团队临床实践指南的新颖验证。

Good Clinical Practice Q&As

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