PTI - international

I. Introduce Clinical Quality Assurance

• Examine the role of quality assurance in clinical research
  • auditing clinical sites
  • writing audit findings and reports
  • becoming a regulatory and compliance "expert"
  • selecting and qualify vendors
  • hosting audits by the FDA

Discussion: Compare Participants' Levels of Experiences and Objectives for this Course

II. Achieve and Maintain GCP Compliance

• Identify the fundamentals of a good clinical audit program
• Demonstrate monitoring, auditing and investigator awareness
• Examine the role of clinical quality assurance in ensuring good clinical practice

III. Audit Internal Clinical Files for GCP Compliance

• Decide when to audit internal files
• Determine what documents should be evaluated
• Incorporate worksheets and checklists to facilitate the process

IV. Audit Clinical Sites for GCP Compliance

• Define the differences between monitoring and auditing
• Identify methods for launching and executing an audit
• Improve your current GCP audit process
• Audit essential documents
• Employ effective interviewing skills

Exercise: Interviewing Techniques - Interviewing the Investigator and Study Coordinator

V. Audit Clinical Data

• Evaluate subject selection, entry, treatment and evaluation
• Utilize effective methods of data sampling
• Incorporate data audit tools and worksheets

Exercise: Discuss the Importance of Performing a Trend Analysis