Good Clinical Practice Q&A

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Good Clinical Practice Q&A

机译：良好的临床实践问答

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Given that a site might maintain records off-site and may not have immediate access to them, how does the FDA interpret the requirement that an FDA inspector be provided with “prompt access” to required study-related records that will be inspected.

机译：鉴于某个站点可能会在异地维护记录，并且可能无法立即访问它们，FDA如何解释要求FDA检查员“迅速访问”要求检查的与研究相关的记录的要求。

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《Journal of Clinical Research Best Practices》 |2020年第3期|共1页
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中图分类临床医学;
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1. Good Clinical Practice Q&A [J] . Journal of Clinical Research Best Practices . 2020,第2期

机译：良好的临床实践问答
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3. Good Clinical Practice Q&A [J] . Brandon May Journal of Clinical Research Best Practices . 2020,第4期

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4. Improving Clinical Practice and Education Using the Electronic Medical Record -Can We Incorporate New Medical Research into Clinical Practice Using the Clinical Data Repository [C] . Natalie DUBOVOY, Julio LAM-SALAZAR, Amy KULE, World multi-conference on systemics, cybernetics and informatics;WMSCI 2010 . 2012

机译：利用电子病历改善临床实践和教育-我们是否可以使用临床数据存储库将新的医学研究纳入临床实践
5. A Clinical Practice Change Initiative to Incorporate Animal Assisted Therapy in Advanced Practice Registered Nurses' Clinical Practice for Children and Adolescents. [D] . Cowell, Donna Rae LaPointe. 2017

机译：将动物辅助疗法纳入高级实践的临床实践变更计划注册了儿童和青少年护士的临床实践。
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

机译：ACC / AHA / ASNC心脏放射性核素成像临床使用指南-执行摘要美国心脏病学会/美国心脏协会实践指南工作组的报告（ACC / AHA / ASNC委员会，对1995年临床使用指南进行修订ACC / AHA实践指导小组）竭尽全力避免由于写作小组成员的外部关系或个人利益而引起的任何实际或潜在的利益冲突。具体来说，要求写作小组的所有成员提供所有可能被视为实际或潜在利益冲突的关系的披露声明。这些声明由上级工作组审查，在第一次会议上向书面小组的所有成员口头报告，并在发生变化时进行更新。55本文件于2003年7月获得美国心脏病学会基金会董事会的批准。 2003年7月，美国心脏协会科学咨询与协调委员会，2003年7月，美国核心脏病学会理事会。66引用该文件时，美国心脏病学会基金会，美国心脏协会和美国核学会心脏病学要求使用以下引用格式：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心脏放射性核素成像临床使用指南-执行摘要：美国心脏病学会/美国心脏协会实践小组工作指南（ACC / AHA / ASNC委员会，修订1995年临床指南）的报告使用放射性核素成像）。 J Am Coll Cardiol 2003; 42：1318–33.77（J Am Coll Cardiol 2003; 42：1318–33）88©2003美国心脏病学会基金会和美国心脏协会版权所有。
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&A

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