|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-clinical-practice-for-healthcare/
课程评论：没有评论
课程名称：医疗卫生领域的良好临床实践 课程概述：良好临床实践（GCP）是一项国际性的伦理和科学质量标准，适用于临床试验的设计、实施、管理、监测、审计、记录、分析和报告。其目的在于保护试验参与者的权利、诚信和机密性。世界医学协会制定的赫尔辛基宣言是一个伦理原则声明，为涉及人类受试者的医学研究提供指导。医师有责任促进和保障人们的健康，医师的知识和良知致力于履行这一职责。 尊重个体是该课程中的重要原则，它承认每个人的尊严和自由，要求获取研究受试者或其合法代表的知情同意。在临床试验中，参与者的选择至关重要，因为每项试验通常针对特定的疾病状况，而每个阶段可能需要不同的症状水平。如果您符合试验的标准，您可能能够参与其中。有时，您可能还需进行特定的测试以确认您是良好的候选人。参与者的个人信息是保密的，并且在研究中不会与您的姓名关联。 研究方案是一个详细的研究计划，像地图一样引导研究的进行。其设计旨在回答特定研究问题，同时保障参与者的健康。值得注意的是，设计高效的研究方案至关重要，因为机构审查委员会的批准往往基于研究方案的内容。 本课程将帮助学员了解良好临床实践的基本原则，确保在医学研究中对参与者权益和健康的有效保护。
Good clinical practice is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. The world medical association has developed the declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. It is the duty of the physician to promote and safeguard the health of people. The physician knowledge and conscience are dedicated to the fulfilment of this duty. Respect for persons is very important, this principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from research subjects or legally authorized representatives. In any trials the people who can take part in the clinical trial is very vital because a trial is typically for certain condition, and each phase might require a different level of symptoms. If you fit the guidelines for a trial, you may be able to participate. Sometimes you might need certain test to confirm that you are a very good candidate. Your personal information is confidential and not attached to your name in the study. A research protocol is a detailed research plan that serves as a road map when you are conducting the study. It is designed to answer specific research questions while at the same time safeguarding the health of the participants. It is very important to note that designing an efficient and effective research protocol is of utmost importance as institutional review board give their approval of a study on the basis of the research protocol.
