Auditing Clinical Trials for GCP Compliance
Course Description
Effective clinical trial auditing reduces the risk of violations, which could result in regulatory enforcement and product delays. This training course provides a step-by-step foundation for auditing to comply with Good Clinical Practices (GCPs). Examples of common site deficiencies and tips on how to detect hidden problems are explored along with implementation of an efficient corrective action plan. Techniques are discussed for evaluating and updating SOPs. You will learn how to ensure HIPAA compliance and how to meet informed consent requirements. Finally, methods to detect fraud and misconduct will be highlighted. Throughout the course, interactive exercises and case study analysis will add to the overall learning experience. In two days, you will learn everything you need to know to protect your company and your patients from serious and harmful risks.
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.