BIO Professional Development
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Clinical Development 101: General Principles
Clinical Development 101: General Principles sets the stage for the entire Biotech Primer clinical development series by covering the essential terms, milestones, and considerations needed to understand the clinical development process. This Primer dives into the core principles of current Good Clinical Practices and how to manage risk for study volunteers. Clinical Development 101 focuses on the most relevant study designs, inclusion/exclusion criteria for selecting participants, and ethical considerations that must be met. The class ends by establishing master data management and reporting standards required for regulatory filings. Register now for Clinical Development 101: General Principles and establish a baseline understanding of clinical trials.
Takeaways
- Enumerate the clinical trial phases in order, explain the purpose of each, and list their milestones.
- Identify the key individuals and groups involved in clinical trials and explain their roles in detail.
- Define foundational drug development concepts to control bias, such as control groups, blinding, and randomization.
- Choose the appropriate study design criteria to reduce bias and ensure patient safety.
- Compile a list of regulatory studies and the data each collects to enable follow-on studies.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
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