a. Monitoring Overview - (40 minutes)
b. Foundation Package
i. An Introduction to the U.S. FDA Regulations
1. Part I: 21 CFR Part 312 and 812 - (55 minutes)
2. Part II: 21 CFR Parts 50, 56, 54, and 11 - (40 minutes)
3. Comparing 21 CFR Parts 312 and 812 - (55 minutes)
ii. Good Clinical Practice
1. The History of Clinical Research - (60 minutes)
2. Introduction to Good Clinical Practice - (40 minutes)
3. The FAIR Shake(TM) Method - (35 minutes) iii. Human Subjects Protection
1. Human Subjects Protection: Drilling Down 21 CFR Part 50 - (40 minutes)
2. Introduction to HIPAA/HITECH - (40 minutes)
c. Monitoring 101 Package
i. Site Assessment Visits - (55 minutes)
ii. Site Initiation Visits - (45 minutes)
iii. Periodic Monitoring Visits - (45 minutes)
iv. Close-Out Visits - (30 minutes)
v. Site Management - (30 minutes)
d. Monitoring 102 Package
i. How to Review Informed Consent - (35 minutes)
ii. How to Review Essential Documents - (40 minutes)
iii. How to Verify Source Data - (45 minutes)
iv. How to Conduct Product Accountability - (40 minutes)
v. Risk-Based Monitoring Overview - (45 minutes)
