Module #1 Introduction to Clinical Trials Overview of clinical trials, importance, and history
Module #2 Types of Clinical Trials Explanation of Phase I, II, III, and IV clinical trials
Module #3 Clinical Trial Design Discussion of different clinical trial designs, including parallel, crossover, and factorial designs
Module #4 Randomization and Blinding Importance and methods of randomization and blinding in clinical trials
Module #5 Ethics in Clinical Trials Discussion of ethical principles, informed consent, and protection of human subjects
Module #6 Regulatory Framework Overview of regulatory agencies, laws, and guidelines governing clinical trials
Module #7 Clinical Trial Protocol Components and development of a clinical trial protocol
Module #8 Investigator Responsibilities Roles and responsibilities of investigators, site staff, and sponsors
Module #9 Informed Consent Process Best practices for obtaining and documenting informed consent
Module #10 Data Collection and Management Methods for collecting, managing, and ensuring data quality in clinical trials
Module #11 Adverse Event Reporting Identification, reporting, and analysis of adverse events in clinical trials
Module #12 Monitoring and Quality Control Importance and methods of monitoring and quality control in clinical trials
Module #13 Data Analysis and Interpretation Basic concepts of statistical analysis and data interpretation in clinical trials
Module #14 Clinical Trial Phases:Phase I In-depth discussion of Phase I clinical trials, including first-in-human studies
Module #15 Clinical Trial Phases:Phase II and III In-depth discussion of Phase II and III clinical trials, including dose-response and pivotal studies
Module #16 Clinical Trial Phases:Phase IV and Post-Marketing In-depth discussion of Phase IV and post-marketing clinical trials, including surveillance and observational studies
Module #17 Special Populations and Considerations Discussion of clinical trials in special populations, including pediatrics, geriatrics, and vulnerable populations
Module #18 Global Clinical Trials Challenges and considerations for conducting clinical trials globally, including international regulations and cultural differences
Module #19 Technology and Innovation in Clinical Trials Discussion of emerging technologies and innovations in clinical trials, including e-consent and decentralized trials
Module #20 Career Paths in Clinical Trials Overview of career opportunities and professional development in clinical trials
Module #21 Real-World Examples and Case Studies Analysis of real-world examples and case studies of clinical trials
Module #22 Common Pitfalls and Challenges Discussion of common pitfalls and challenges in clinical trials, including trial termination and amendments
Module #23 Future Directions and Trends Discussion of future directions and trends in clinical trials, including personalized medicine and artificial intelligence
Module #24 Clinical Trial Funding and Sponsorship Overview of funding mechanisms and sponsorship models for clinical trials
Module #25 Clinical Trial Publication and Dissemination Best practices for publishing and disseminating clinical trial results
Module #26 Audit and Inspection Preparation Preparation and conduct of clinical trial audits and inspections
Module #27 Clinical Trial Site Management Best practices for managing clinical trial sites, including site selection and activation
Module #28 Virtual Clinical Trials Discussion of virtual clinical trials, including remote patient monitoring and telemedicine
Module #29 Diversity, Equity, and Inclusion in Clinical Trials Importance and strategies for promoting diversity, equity, and inclusion in clinical trials
Module #30 Course Wrap-Up & Conclusion Planning next steps in Introduction to Clinical Trials career
