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WIZAPE
Apprentice Mode
10 Modules / ~100 pages
Wizard Mode
~25 Modules / ~400 pages

Clinical Research Design and Management
( 25 Modules )

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


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