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Introduction to Microbial Genomics & Metagenomics培訓(xùn)

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授課地點及時間

上課地點：【上?！浚和瑵髮W(xué)(滬西)/新城金郡商務(wù)樓(11號線白銀路站) 【深圳分部】：電影大廈(地鐵一號線大劇院站)/深圳大學(xué)成教院【北京分部】：北京中山學(xué)院/福鑫大樓【南京分部】：金港大廈(和燕路) 【武漢分部】：佳源大廈（高新二路）【成都分部】：領(lǐng)館區(qū)1號（中和大道）【廣州分部】：廣糧大廈【西安分部】：協(xié)同大廈【沈陽分部】：沈陽理工大學(xué)/六宅臻品【鄭州分部】：鄭州大學(xué)/錦華大廈【石家莊分部】：河北科技大學(xué)/瑞景大廈
開班時間(連續(xù)班/晚班/周末班）：2020年3月16日

課時

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☆課程大綱☆

Introduction

Overview of the Different Types of Clinical Research and Understanding the GCP Focus in Each One

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA-Based)
GCP for Clinical Investigations of Devices
GCP for Clinical Trials with Investigational Drugs and Biologics
(ICH-Based)
GCP for Social and Behavioral Clinical Research
Understanding Ethics and the Role of Institutional Review Boards (IRBs) in Clinical Trials and Researches

Overview of the Role, Purpose, and Basic Requirements of the ICH E6 GCP Guidelines

Understanding the Difference Between ICH GCP E6 and U.S. FDA Regulations

Understanding the Role and Responsibilities of the Investigator in Clinical Trials

Understanding the Role and Responsibilities of Industry Sponsors in Clinical Trials Under an Investigational New Drug (IND) Application

Understanding Informed Consent Requirements and How to Obtain and Document Consent

Implementing Privacy Policies and Ensuring Confidentiality of Participants in Your Clinical Trials

Ensuring Participant Safety and Well-Being in Your Clinical Trials

Detecting, Evaluating, and Reporting Adverse Events in Your Clinical Trials

Conducting Data Quality Assurance and Integrity in Your Clinical Research

Designing and Conducting the Clinical Trial / Clinical Research Protocol

Understanding the Importance of Protocol Compliance in Your Clinical Trials

Conducting Clear and Proper Documentation and Record-Keeping in Your Clinical Trials

Understanding and Preparing for the Process of Audits and Inspections of Clinical Trials

Avoiding Research Misconduct

Recruiting and Retaining Participants for Your Clinical Trials

Crafting and Negotiating the Clinical Trial Agreement (CTA)

Summary and Conclusion

	備案號：備案號:滬ICP備08026168號-1	.(2024年07月24日)....................
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