Session 1 - Defining the Basic Requirements of GCP

• Terminology
• Overview of clinical compliance laws
  • FDA and ICH requirements
• Understanding the role of the FDA, OHRP and IRBs
• How the GCP guidelines helps in good studies
• Understanding the roles and responsibilities of the clinical research team
• Group discussion of interpreting regulatory requirements for GCP 

Session 2 - Industry Overview – FDA Regulatory Requirements – Are You Ready for an FDA Inspection?

• Understanding Regulatory Obligations
• Identifying Key Documents
• Compliance Issues

Session 3 - The Different Types of Audits

• When and Why to Audit
• Who and What is Inspected
• Audit Problems and Issues
• What to Avoid
• Data Quality and Integrity Issues & solutions 

Session 4 - Role of Monitoring in Detecting Misconduct

• Defining the difference between auditing and monitoring
• What are the big items that must be in place
• Common problems
• Knowing what questions to ask in monitoring a site
• Pointing out site performance deficiencies
• Identifying solutions to deficiencies
• What to do if misconduct is suspected

• Preparing for the visit
• Source documentation: How much is enough?
• Common GCP deficiencies
• Review potential roadblocks of non-compliance
• Identifying potential problems early

Session 6 - Audit Outcomes

• What to Expect
• Common findings
• How to Respond
• How to Follow-Up

Session 7 - Preventing Fraud and Scientific Misconduct

• Maintaining accurate records
• How to detect fraud in case report forms and clinical trial materials
• Misleading data and results
• Examples of fraud

• Identifying other groups
• Role in the detection of fraud and misconduct
• Interactions with FDA and consequences

RETURN TO COURSE DESCRIPTION