PTI - international

Training Overview

• Audit clinical trials for adherence to Good Clinical Practice (GCP) regulations and run a compliant and efficient clinical trial
• Identify and avoid the consequences of non-compliance, misconduct and fraud to avoid costly delays
• Review common pitfalls within clinical trials and recognize potential problem areas before it is too late
• Write, implement and update Standard Operating Procedures (SOPs) to establish a solid backbone to your auditing program
• Develop tools for auditing internal clinical files, clinical sites and clinical data and improve your auditing ability
• Master interviewing skills to effectively obtain necessary information from clinical sites
• Complete a clinical data trend analysis—an early warning teller of potential problems
• Document findings properly in an audit report and provide management with a clear understanding of your audit
• Ensure compliance with informed consent requirements and HIPAA privacy rule
• Select and qualify vendors to ensure outsourced areas meet regulatory standards
• Anticipate, prepare for and manage FDA inspections  so you never get caught off guard

PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-06-014-L04. Initial release: 07/2006.