Ethics and Compliance in Clinical Research
( 25 Modules )

Module #1
Introduction to Ethics in Clinical Research
Overview of ethical principles and Importance of ethics in clinical research

Module #2
History of Research Ethics
Landmark cases and events that shaped research ethics

Module #3
Core Ethical Principles
Respect for persons, beneficence, justice, and fairness in research

Module #4
Informed Consent
Principles and procedures for obtaining informed consent

Module #5
Vulnerable Populations
Ethical considerations for research involving vulnerable populations

Module #6
Risk and Benefit Assessment
Evaluating risks and benefits in clinical research

Module #7
Regulatory Framework
Overview of laws, regulations, and guidelines governing clinical research

Module #8
ICH-GCP and International Regulations
International Conference on Harmonization - Good Clinical Practice and international regulations

Module #9
Institutional Review Boards (IRBs)
Role and responsibilities of IRBs in clinical research

Module #10
Compliance and Quality Assurance
Importance of compliance and quality assurance in clinical research

Module #11
Good Clinical Practice (GCP) Essentials
Fundamentals of Good Clinical Practice in clinical trials

Module #12
Investigators and Site Management
Roles and responsibilities of investigators and site management in clinical trials

Module #13
Data Management and Integrity
Ensuring data quality, accuracy, and integrity in clinical trials

Module #14
Safety Reporting and Adverse Event Management
Identifying, reporting, and managing safety issues in clinical trials

Module #15
Confidentiality and Data Protection
Protecting participant confidentiality and personal data in clinical research

Module #16
Financial Disclosure and Conflict of Interest
Managing financial conflicts of interest in clinical research

Module #17
Audits and Inspections
Preparing for and responding to audits and inspections in clinical research

Module #18
Post-Marketing Surveillance and Pharmacovigilance
Monitoring drug safety after approval and pharmacovigilance

Module #19
Ethical Considerations in Special Populations
Ethical considerations for research involving children, pregnant women, and prisoners

Module #20
Cultural Competence in Clinical Research
Addressing cultural diversity and linguistic barriers in clinical research

Module #21
Research Misconduct and Fraud
Defining and responding to research misconduct and fraud

Module #22
Whistleblower Protection and Reporting
Protecting whistleblowers and reporting research misconduct

Module #23
Collaboration and Partnerships
Ethical considerations for collaboration and partnerships in clinical research

Module #24
Globalization and Cross-Border Research
Ethical challenges and considerations for global clinical trials

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Ethics and Compliance in Clinical Research career

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Ethics and Compliance in Clinical Research ( 25 Modules )

Ethics and Compliance in Clinical Research
( 25 Modules )