Clinical Trials Management and Advanced Operations

所在平台: Coursera

课程主页: https://www.coursera.org/learn/clinical-trials-management-and-advanced-operations

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课程简介

课程名称：临床试验管理与高级操作 概述：在本课程中，您将学习到临床试验管理的高级要素。从预见和规划协议事件到进行系统性评估以合成证据，您和您的研究团队需要具备在整个试验过程中实施最佳实践的能力。您将学习如何识别和应对问题和不良事件，遵守法规，并参与促进透明度的框架。此外，您还将了解系统评审和荟萃分析的相关知识。 课程大纲： 1. **协议事件** 描述：协议事件是临床试验过程中发生的各类问题，影响患者安全、数据完整性或其他试验方面，需要适当分类和报告。您和团队需准备好识别、记录和应对每种类型的协议事件。 2. **监管事务与试验不当行为** 描述：本模块将介绍临床试验中的监管事务，以及如何避免与协议事件不同的试验不当行为。试验研究者需要遵循联邦及地方标准，而机构审查委员会（IRB）和联邦机构负责执行监管。参与欺诈或试验不当行为的研究者可能面临资金损失或法律后果，因此，您和团队必须了解这些期望，并在试验过程中严格遵守。 3. **标准化、透明度与研究可重复性** 描述：本模块讨论研究实践的标准化、研究活动的透明性和研究的可重复性。标准化能改善结果传播，减少试验间的选择性报告，而且帮助提供全面的证据视图。研究实践标准化使研究得以复制，确保其他研究者能验证您的结果。透明性则便于期刊编辑和审查者有效审议研究数据，最终，协议开发和试验登记使研究者承担预先在协议中规定的结果。 4. **证据综合：系统评审与荟萃分析简介** 描述：在本模块中，您将学习如何通过综合多项试验的证据来解决临床试验的相关问题。系统评审聚焦于特定问题，使用明确、透明且可重复的科学方法识别、选择、评估并总结相似但独立的研究。而荟萃分析则是系统评审的可选部分，允许对相似试验的结果进行定量评估。 5. **研究文件** 描述：在本模块中，您将学习临床试验中使用的标准化研究文件，包括文件类型及其用途。同时，您还将学习创建研究文件的最佳实践及其管理原则。 通过本课程，您将获得实施有效临床试验的深厚知识和技能。

课程大纲

Name:Protocol Events

Description:Protocol events are problems of varying magnitude that happen over the course of a clinical trial. They can affect patient safety, data integrity, or other aspects of the trial and need to be appropriately categorized and reported. You and your team need to be prepared to recognize, document, and respond to every type of protocol event.

Name:Regulatory Affairs and Trial Misconduct

Description:In this module, you’ll learn about regulatory affairs in clinical trials and how to avoid trial misconduct, which is handled differently from protocol events. Trial investigators are held to federal and local standards in their study conduct, and Institutional Review Boards (IRBs) along with federal agencies are in charge of enforcement. The ramifications for trial investigators engaging in fraud or trial misconduct can result in loss of funding or even legal consequences, so you and your team need to be aware of these expectations and plan for strict compliance throughout your trial.

Name:Standardization, Transparency, and Research Reproducibility

Description:In this module, we'll be discussing standardization of research practices, transparency of study activities, and research reproducibility. Standardization improves dissemination of results, easing the possibility of selective reporting between trials and facilitating a complete view of the full body of evidence. Standards for research practice enable study replication, allowing other investigators to duplicate your results for verification purposes. Transparency allows for effective adjudication by journal editors and others who might wish to review your study data. Finally, protocol development and trial registries hold the investigators to the outcomes they pre-specified in their protocol development.

Name:Evidence Synthesis: Introduction to Systematic Reviews and Meta-Analysis

Description:In this module, you’ll learn about addressing a clinical trial question of interest by synthesizing evidence from various trials. A systematic review focuses on a specific question, and systematic reviewers use explicit, transparent, and replicable scientific methods to identify, select, appraise, and summarize similar but separate studies. Meta-analysis is an optional component of systematic reviews that allows quantitative assessments of outcomes from similar trials.

Name:Study Documents

Description:In this module, you’ll learn about the standardized study documents used in a clinical trial, including the types of documents and why they’re used. You’ll also learn best practices for creating study documents and the principles for maintaining and managing them.

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