• Terminology
• Overview of clinical compliance laws

            -FDA and ICH requirements
            -21 CFR Part 11

• 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 teams
• Group discussion of interpreting regulatory requirements for GCP

• General requirements of the informed consent
• OHRP role related to Human Subject Protection
• Improving the informed consent process
• Confidentiality of data
• Privacy of subject’s information
• Ethical issues

• What are the requirements of ICH and FDA regulations for GCP
• Interpret and apply international GCP/ICH standards
• How good SOPs help avoid 483s and speed up the process

• 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

Case study analysis, exercises and quizzes may be administered throughout the course to measure performance improvement.

• Role of the Principal investigator
• Role of the Clinical Research Coordinator
• Recordkeeping requirements and documentation
• Importance of Laboratory data
• Importance of Drug accountability

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

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

• Definitions and commonly used terminology
• Reporting requirements from the investigator and sponsor
• Time Frames of Reporting

• Computerized clinical data management
• CFRs vs. eCFRs
• Complying with 21 CFR Part 11
• How much clinical data is enough
• Making sure your records and reporting are accurate