Regulations and Guidance
Overview
Explore the federal and international regulations that protect human participants in research studies. Then use what you’ve learned to conduct interviews and protocol reviews in audit scenarios.
Learning Objectives
- Describe potential regulation violations and their impact
- Conduct audit scenarios and Identify regulation violations based on the available data
- Explain how protocol violations impact clinical research trials
- Conduct interviews and recognize protocol violations in several example scenarios
Related
eLearning
In this interactive exercise, you will learn the importance of batch documents by reviewing the... more
In this interactive exercise, you will learn the importance of batch documents by reviewing the... more
eLearning
Lesson 1: Introduction to Current Good Manufacturing Practices, introduces the fundamentals of cGMP... more
Lesson 1: Introduction to Current Good Manufacturing Practices, introduces the fundamentals of cGMP... more
eLearning
You’re the newest member of the Quality Assurance department at CATT – the Center for the... more
You’re the newest member of the Quality Assurance department at CATT – the Center for the... more
eLearning
This course provides a general overview of the process used to develop drugs and why it costs so... more
This course provides a general overview of the process used to develop drugs and why it costs so... more
- 1 of 7
- >