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相关概念视频

Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

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The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
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Nursing Clinical Information System01:27

Nursing Clinical Information System

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Nursing Clinical Information System (NCIS)
A Nursing Clinical Information System (NCIS) is a specialized type of healthcare information system tailored to meet the unique needs of nursing practice. It incorporates the principles of nursing informatics to streamline information management and improve the quality of care delivery.
Critical attributes of NCIS include:
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Guidelines and Strategies for Safe Computer Charting01:18

Guidelines and Strategies for Safe Computer Charting

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The guidelines and strategies provided by the American Nurses Association (ANA) and the Canadian Nurses Association (CNA) offer essential principles for ensuring safe and secure computer charting systems in healthcare settings. Let's break down each recommendation:
Maintain Confidentiality and Security:
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Health Information Technology and Healthcare Information System01:30

Health Information Technology and Healthcare Information System

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Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
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Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

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Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
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Methods of Documentation V: CBE01:23

Methods of Documentation V: CBE

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Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
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相关实验视频

Updated: Jun 1, 2025

Development and Implementation of a Multi-Disciplinary Technology Enhanced Care Pathway for Youth and Adults with Concussion
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为数据中心项目协调开发具有成本效益和效率的安全案例管理解决方案.

Katrina D Burson1, Michelle H Walter1, Jeanette O Auman2

  • 1RTI International Center for Clinical Research, 3040 East Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC 27709-2194, USA.

Contemporary clinical trials
|January 18, 2025
PubMed
概括

定制安全案例管理解决方案为临床试验提供了一种高效,经济高效的替代方案,而不是专门用于临床试验的药监软件. 这种方法非常适合数据协调中心和管理严重不良事件 (SAE) 和疑似意外严重不良反应 (SUSAR) 的学术网站.

关键词:
临床试验中的临床试验.数据协调中心数据协调中心.药物监督 药物监督 药物监督安全案例管理安全案例管理

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科学领域:

  • 临床研究操作临床研究操作
  • 药物监督 药物监督 药物监督
  • 监管合规性 监管合规性

背景情况:

  • 集中安全功能简化了多个临床试验的严重不良事件 (SAE) 管理.
  • 以前的依赖FDA监管的药监软件 (符合21 CFR第11部分) 导致由于系统不兼容性和低量SUSARs的高成本导致效率低下.

研究的目的:

  • 为数据协调中心 (DCC) 开发和实施具有成本效益,高效,定制的安全案例管理解决方案.
  • 证明在没有专门的药物监管软件的情况下满足监管报告要求的可行性,特别是对于具有较低SUSAR数量的组织.

主要方法:

  • 在数据协调中心内对现有的工作流程,系统和流程进行内部分析.
  • 开发一种定制解决方案,利用现有的电子数据捕获 (EDC) 和文档管理系统.
  • 确保遵守FDA法规,包括21 CFR第11部分,没有额外的软件费用.

主要成果:

  • 开发了一个定制的安全案例管理流程,模仿了以前软件的关键功能.
  • 新解决方案于2022年12月实施,利用现有基础设施.
  • 定制流程确保了21 CFR第11部分的合规性,并提供了一个具有成本效益的替代方案.

结论:

  • 定制的安全案例管理解决方案有利于DCC和需要满足监管报告要求的学术研究场所.
  • 这种方法为处理有限数量的疑似意外严重不良反应 (SUSARs) 的组织提供了具有成本效益的选择.
  • 从开发和实施过程中吸取的经验教训为类似组织提供了宝贵的见解.