Lessons
Learning Objectives:
- Describe how quality protocols are developed
- Define the different study models and requirements for protocol authoring
- Review protocol to ensure operational feasibility and compliance
- Communicate the feasibility of a study
Tools Provided:
- Testing a Hypothesis
- Protocol Components Worksheet
- Research Design Models
- Feasibility Assessment Checklist
- Case Study Guide
Audience:
Primary: Clinical Research Personnel involved with protocol development and/or feasibility assessment
Secondary: All Clinical Research Personnel
Knowledge level (basic, intermediate, advanced): Basic
Competency (Related to the following Core Competencies):
Scientific Concepts and Research Design
Study and Site Management
Activities Included:
Understanding Clinical Trials Protocols: Key Considerations for Effective Development and Feasibility Review (No Contact Hours)
Evaluation