Module #1 Introduction to Clinical Research Overview of clinical research, importance, and relevance in healthcare
Module #2 Ethical Principles in Clinical Research Ethical considerations, principles, and guidelines in clinical research
Module #3 Regulatory Framework for Clinical Research Overview of regulatory agencies, laws, and guidelines governing clinical research
Module #4 Study Designs in Clinical Research Types of study designs, including observational, interventional, and hybrid designs
Module #5 Randomized Controlled Trials (RCTs) Design, conduct, and analysis of RCTs, including advantages and limitations
Module #6 Non-Randomized Interventional Studies Design, conduct, and analysis of non-randomized interventional studies
Module #7 Observational Studies Design, conduct, and analysis of observational studies, including cohort, case-control, and cross-sectional studies
Module #8 Survival Analysis and Time-to-Event Data Introduction to survival analysis, Kaplan-Meier estimates, and Cox proportional hazards model
Module #9 Sample Size Calculation and Power Analysis Principles of sample size calculation, power analysis, and sample size determination
Module #10 Data Management and Quality Control Data management principles, data quality control, and data cleaning and preprocessing
Module #11 Clinical Trial Protocol Development Development of clinical trial protocols, including content, structure, and requirements
Module #12 Investigator and Site Selection Principles and best practices for selecting investigators and research sites
Module #13 Informed Consent and Participant Recruitment Informed consent principles, participant recruitment strategies, and retention techniques
Module #14 Data Monitoring and Safety Boards Role and responsibilities of data monitoring committees and safety boards
Module #15 Clinical Research Coordinator Roles and Responsibilities Duties and responsibilities of clinical research coordinators in clinical trials
Module #16 GCP, ICH, and Regulatory Compliance Good clinical practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory compliance
Module #17 Clinical Trial Budgeting and Financial Management Budgeting, financial management, and cost control in clinical trials
Module #18 Risk Management and Quality Assurance Risk management strategies, quality assurance, and quality control in clinical trials
Module #19 Audits and Inspections Types of audits and inspections, preparation, and response to findings
Module #20 Case Report Forms and Data Collection Design, development, and use of case report forms, and data collection strategies
Module #21 Statistical Analysis and Data Interpretation Introduction to statistical analysis, data interpretation, and results presentation
Module #22 Clinical Trial Reporting and Publication Principles of clinical trial reporting, publication, and dissemination of results
Module #23 Good Clinical Laboratory Practice (GCLP) GCLP principles, requirements, and implementation in clinical trials
Module #24 Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS) EDC, CTMS, and other electronic systems used in clinical trials
Module #25 Course Wrap-Up & Conclusion Planning next steps in Clinical Research Design and Management career
