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所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-clinical-practice-gcp-self-assessment-exam/
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**课程名称：** 良好临床实践 (GCP) - 自我评估考试 **课程概述：** 本课程旨在帮助您检验作为临床试验专家的ICH E6良好临床实践 (GCP) 指南知识。本次考试包含最佳选择题，不仅适用于研究者和研究中心人员，对于CRA、临床质量保证、注册事务部门和临床运营人员也至关重要。无论您是已有临床研究经验还是有意进入该领域，本课程都能帮助您评估自身对GCP角色和管理合规临床试验的知识掌握程度。 **评估重点领域：** * GCP术语 * GCP原则 * 知情同意 * 研究产品 * 试验特定文档 * 数据完整性关键原则 * GCP的“应做”与“不应做” **课程价值：** * **知识验证：** 确认您对关键ICH-GCP要求和临床试验法规期望的理解。 * **职责明确：** 证实您了解研究者/研究团队在临床试验中的责任。 * **流程掌握：** 检验您对临床试验活动的进行方式、时间及文档记录方式的理解。 **“思考题”：** 如果您认为自己是ICH GCP E6 (R2)的专家，并已通过相关课程或拥有实际工作经验，那么是时候进行一次自我评估了！参加此次考试，检验您是否需要进一步学习，或是以此证明您的知识和专业能力。无论结果如何，您都将受益。 **关于认证：** Udemy通常不为考试提供认证，仅为视频课程提供。然而，对于本次GCP考试，付费学员若考试成绩达到80%或以上，可申请手动获得证书。证书将在月底统一发放。
VALIDATE YOUR KNOWLEDGE AS A SUCCESSFUL CLINICAL TRIAL EXPERT ON ICH E6 GOOD CLINICAL PRACTICE (GCP) GUIDELINEGCP SELF-ASSESSMENT EXAMThis is an exam based on best choice questions. It is designed not only for giving provision to investigators and site staff but also the assessment is important for CRAs, Clinical QA, Regulatory Affairs departments and Clinical Operations staff. This exam will empower professionals, whether presently taking part in clinical research or looking to get involved as a prospective career. It will help to self assess their knowledge on GCP roles and how to manage a GCP compliance clinical trial. The learners will be assessed on following important areas of GCP:• GCP Terminologies• GCP Principles• Informed consent• Investigation products • Trial specific documentation• Data integrity key principles• Dos and Donts of GCP--------------------------------------------------------------Food for ThoughtBe Familiar with ICH GCP E6 (R2) knowledge which you hold.If you think you are an expert in ICH GCP E6 (R2) after taking courses on the subject and working with it...You need to hold on!Join this exam and self-assess yourself!Maybe you need to learn and learn...Or you can prove your knowledge and expertise by completing this exam.Both ways, you are in a win-win situation.--------------------------------------------------------------Certification: Udemy does not provide certification for exams; they only do in the case of Video Courses. But the great news here is, we have empowered our paid students to have a certificate once they qualify by 80% in the exams. It is a manual process in which learners are requested to submit evidence of qualification and apply for the certificate. The certificates are issued at the end of a month.--------------------------------------------------------------THIS SELF ASSESSMENT GCP COURSE WILL HELP YOU TO:Confirm you comprehension on the key ICH-GCP requirements and regulatory expectations regarding conduct of clinical trialsConfirm that you know the responsibilities of an investigator/ investigator team within clinical trialsVerify your understanding why, when and how clinical trial activities are to be conducted and documented
