Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities

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.