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所在平台: Udemy |
课程主页: https://www.udemy.com/course/strategies-to-be-a-successful-clinical-research-associate/
课程评论：没有评论
**课程名称：** 成为成功的临床研究助理 (CRA) 的策略 **课程概述：** 本课程面向学生和在职专业人士，提供关于临床研究助理 (CRA) 的全面知识。学员将深入了解 CRA 的角色、职责以及药物/器械/疫苗临床开发各个阶段的任务。CRA 是一名拥有生命科学学士或硕士学位的临床研究专业人士，负责在试验现场对试验进行监督。 课程将详细介绍临床开发四个主要阶段： 1. **研究规划：** 涵盖研究设计、方案制定以及病例报告表 (CRF) 的设计与开发。 2. **研究启动：** 包括向试验单位提交患者知情同意审查委员会 (IRB) 批准所需的重要文件、研究者选择、启动研究者会议以及现场启动访问。 3. **研究监查：** 重点介绍监查访问的准备工作，包括监查计划的制定。监查内容涵盖严重不良事件 (SAE) 审核、知情同意书审核、依从性检查、CRF 和原始文件审阅、试验用药品管理、疑点和错误纠正、研究者试验文件 (ISF) 审阅。监查访问还包括撰写监查访问报告。 4. **研究结束：** 涉及 CRF 的完成、药品管理、研究者试验文件、研究者提交给申办方和 IRB 的最终报告、行政事务以及最终访问报告。 此外，本课程还将强调 CRA 在培训研究单位进行知情同意流程、文件管理和不良事件报告方面的重要性。
Students or Working professionals taking this course would get detailed knowledge of who is a Clinical Research Associate, what are his responsibilities in various stages of Clinical development of a Drug/Device/Vaccine. A CRA is a Clinical research professional with Bachelors/Master's degree in any Life sciences who monitors a trial at the Trial Site. There are 4 stages in Clinical Development such as-1) Study Planning which involves working on Study design, Protocol development and Case report form Design and development. 2) Study Initiation which involves submitting various essentials document for IRB approval to trial site, Investigator selection, Initiating Investigator's meeting, Site Initiation visit, etc. 3) Study Monitoring which involves Preparing for a Monitoring visit, Monitoring plan which includes Serious Adverse event review, Informed consent review, Checking Protocol adherence, Case report form and Source document review, Investigational product accountability, Queries and error correction, Review of Investigator study file. Monitoring visit also involves completion of Monitoring visit report. 4) Study Close-out includes addressing items such as Case report forms, Drug accountability, Investigator's study file, Investigator's final report to Sponsor and IRB, Administrative issues and Final Visit report.This course also highlights importance of CRA in training site for Informed consent process and documentation and Adverse event reporting.
