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