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所在平台: Udemy |
课程主页: https://www.udemy.com/course/clinical-research-advance-audiotestcertificate/
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课程名称：临床研究进阶课程（音频+测试+证书） 课程概述：临床研究进阶课程旨在为学生、研究人员、研究协调员、赞助商、临床项目经理、监测员以及其他临床研究人员提供深入的临床研究知识，以助其在临床研究行业中获得高端职位。该课程根据行业期望，设计了所需的高级知识，结构合理。课程中融入了实践测试及基于案例的情境学习。学员将学习临床研究的原则和流程、重要文件、临床试验术语，以及在开发新治疗方法和干预措施过程中对临床试验设计与类型的理解。 适合人群： 1. 药学的本科或研究生学位 2. 医学或其他医疗相关专业的本科或研究生学位 3. 生命科学的本科或研究生学位 4. 来自相关医疗行业的任何人 课程内容涵盖： 模块1：临床试验的重要性与类型 模块2：临床试验阶段及关键参与者概览 模块3：国际会议（ICH）良好临床实践（GCP）原则 模块4：重要文件 - 研究方案 - 知情同意文件（ICD） - 病例报告表（CRF） - 研究者手册（IB） 模块5：临床试验监管机构 - 美国FDA - 英国MHRA - 欧盟EMA - 日本PMDA - 加拿大DSC 模块6：审计与检查 模块7：特殊人群临床试验 - 老年人、儿童、特殊及弱势群体等 模块8：临床试验设计 模块9：案例研究 模块10：临床试验术语 该课程结合了音频学习和测试，成功完成后将获得证书。
The objective of the Clinical Research -advance course is to provide detailed clinical research knowledge to students, Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors, and any other Clinical Study staff to reach top-end positions in the clinical research Industry.This course is developed and structured in a manner considering the advance level of knowledge required in view of industry expectations. This course is integrated with practice tests in between including case study-based scenarios. In this course, you'll learn principles and processes of clinical research, essential documents, clinical trial terminologies, understanding of the design & types of clinical trials in developing new treatments and interventions.Who Should Enroll?1. Graduate or postgraduate degree in Pharmacy2. Graduate or postgraduate degree in Medicine or any healthcare stream3. Graduate or postgraduate degree in Life Sciences4. Anyone from a related healthcare industryWhat This Course Covers?Module 1: Importance & Types of Clinical TrialsModule 2: Clinical Trial Phases & Key Players at GlanceModule 3: ICH GCP PrinciplesModule 4: Essential Documentso Protocolo Informed Consent Document (ICD)o Case Report Form (CRF)o Investigators Brochure (IB)Module 5: Clinical Trial Regulatory Bodieso US-FDAo MHRAo EMAo PMDAo CDSCOModule 6: Audit & InspectionModule 7: Special Population Clinical Trialso Geriatrico Paediatrico Special & Vulnerable Population etc.Module 8: Clinical Trial DesignsModule 9: Case StudiesModule 10: Clinical Trial Terminologies
