Clinical Research Methods
( 25 Modules )

Module #1
Introduction to Clinical Research
Overview of clinical research, importance, and applications

Module #2
Ethics in Clinical Research
Principles of ethical conduct, regulatory frameworks, and informed consent

Module #3
Study Designs in Clinical Research
Types of study designs, including observational, experimental, and quasi-experimental

Module #4
Research Questions and Objectives
Formulating research questions, hypotheses, and objectives

Module #5
Literature Review and Search Strategies
Conducting a literature review, search strategies, and critical appraisal

Module #6
Measures and Instruments in Clinical Research
Types of measures, instrument development, and validation

Module #7
Sampling and Recruitment Strategies
Sampling methods, recruitment strategies, and participant selection

Module #8
Data Management and Quality Control
Data management principles, data quality control, and data cleaning

Module #9
Descriptive Statistics and Data Visualization
Descriptive statistics, data visualization, and graphical displays

Module #10
Inferential Statistics
Hypothesis testing, confidence intervals, and p-values

Module #11
Introduction to Epidemiology
Basic epidemiological concepts, disease frequency measures, and association

Module #12
Types of Clinical Trials
Phases of clinical trials, trial designs, and special types of trials

Module #13
Randomization and Blinding in Clinical Trials
Randomization methods, blinding, and allocation concealment

Module #14
Sample Size Calculation andPower Analysis
Sample size calculation, power analysis, and sample size determination

Module #15
Survival Analysis and Time-to-Event Data
Survival analysis, Kaplan-Meier curves, and Cox proportional hazards model

Module #16
Introduction to Regression Analysis
Simple and multiple linear regression, assumptions, and inference

Module #17
Analysis of Variance (ANOVA) and Covariance (ANCOVA)
One-way and two-way ANOVA, ANCOVA, and repeated measures designs

Module #18
Non-Inferiority and Equivalence Trials
Non-inferiority and equivalence trials, margin of non-inferiority, and equivalence bounds

Module #19
Adaptive Clinical Trials
Adaptive designs, group sequential methods, and seamless phase II/III trials

Module #20
Meta-Analysis and Systematic Reviews
Meta-analysis, systematic reviews, and critical appraisal of published research

Module #21
Good Clinical Practice (GCP) and Regulatory Requirements
GCP, FDA regulations, and ICH guidelines

Module #22
Data Monitoring Committees (DMCs) and Safety Reporting
DMCs, safety reporting, and adverse event management

Module #23
Clinical Research in Special Populations
Research in pediatrics, geriatrics, and vulnerable populations

Module #24
Implementation Science and Knowledge Translation
Implementation science, knowledge translation, and dissemination

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

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