Master the Arts & Science of GCP Compliance Clinical Trials

سرفصل های دوره

Navigate the complexities of clinical trials with expertise in GCP, ethical practices, and compliance.

1 - Foundations of Clinical Research and Regulatory Framework

1 - Ethical Considerations in Clinical Research

2 - Importance of Good Clinical Practice

3 - Understanding Regulatory Framework in Clinical Research

4 - Roles of Coordinators and Investigators

5 - Clinical Trial Success Recruitment Challenges and Retention

6 - Quality Assurance in Clinical Research

2 - Study Design Protocol Development and Informed Consent

7 - Protocol Development and Key Elements

8 - Protocol Amendments and Deviations

9 - Overview of Clinical Research Study

10 - Understanding Clinical Research Protocols

11 - Ensuring Inclusivity and Diversity

12 - Essential Documents in Clinical Research

3 - Good Clinical Practice Guidelines and Compliance

13 - Good Clinical Practice Guidelines

14 - Institutional Review Boards and Ethics Committees

15 - FDA Regulations and Guidelines in Clinical Research Conduct

16 - ICHGCP Principles

17 - GCP Compliance and Quality Assurance

18 - GCP Audit and Inspection Understanding the Differences

4 - Regulatory Compliance in Clinical Research

19 - Regulatory Affairs in Clinical Research

20 - FDA Regulations for Clinical Trials

21 - International Regulatory Requirements

22 - Protocol Amendments and Clinical Trials

23 - Importance of Safety Reporting

24 - Safety Reporting and Adverse Events

5 - Data Management and Record Keeping Challenges

25 - Clinical Data Management

26 - Data Collection in Clinical Research

27 - Essential Docs In Clinical Research

28 - Electronic Data Capture System in Clinical Research

29 - Data Validation and QC in Clinical Research

30 - Understanding the Essentials of TMF

6 - Monitoring and Reporting in Clinical Trials

31 - Introduction to Clinical Trial Monitoring

32 - Clinical Research Monitoring Importance and Actions

33 - Understanding the Role of CRC and Investigators

34 - Strategies for Ensuring Compliance and Conducting MV

35 - Research Monitoring Understanding Roles and Responsibilities

36 - Site Selection in Clinical Trials

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تولید کننده: Udemy