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The second in a series of four courses, this course covers the processes and procedures inherent to planning clinical trials, including protocol development, case report form design, IRB submission, site selection, developing and negotiating site contracts and budgets, pre-study visits, statistics in clinical trials, data management and capture, and electronic records.
Course Outline
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Course Objectives
- Understand the general principles of clinical research and biostatistics
- State the crucial role of biostatistics in clinical trial design, data analyses and reporting
- List the common terms used in biostatistics applicable to clinical trials such as hypothesis testing, endpoints, target population, sample size, confidence interval, etc.
- Discuss the data management plan and how it is developed
- Describe how a clinical trial database is set up and validated
- Define the purpose of a protocol and identify the required contents
- Describe the types of case report forms and the parameters for designing case report forms (CRFs)
- Define the required elements of informed consent and describe the process for administering informed consent
- Understand the elements of a clinical trial agreement and their regulatory and business implications
- Identify the tools and resources to develop a site budget
- Understand the development and negotiating process for finalizing contracts and budgets
- List the activities to be performed for the selection of qualified investigators, staff and investigational site
- Describe the procedures for conduct and follow-up of pre-study visits
- Describe the regulations, issues and other considerations in conducting studies in the global arena, with a detailed look at the move toward harmonization
- Provide references to governing regulatory requirements, guidelines and best practices
- Understand the IRB submission process and required documents
- Understand the regulations and guidelines for electronic records and signatures
What You Learn
- Biostatistics
- Data management
- Clinical trial content and process
- Electronic records
- Case report forms
- Data plan development
- Database setup and validation
- Informed consent and investigators
- IRB submission
- Selecting investigators, staff and site
- Developing and negotiating site budgets
- Site contracts
- Pre-study visit
How You Learn
- Online lectures
- Reading assignments
- Discussions
- Written assignments
- Midterm and final exams
Is This Course Right for Me?
This class is geared for those who are new to clinical trials and to those entering the clinical research field.