Clinical Trials

Biography

Biography: Tamera N Smith

Abstract

Clinical research misconduct and fraud continues to impact solid research efforts and increases human research participate risks while participating in vital research efforts. Clinical research professionals continue to need knowledge, skills and prevention and detection skills to eliminate negative compliance outcomes. Every research professional has roles and responsibilities to care for those that participate. Every research professional has roles and responsibilities to ensure proper results are reported for key decisions on study results. Join with us as we dissect recent cases of scientific and medical misconduct and fraud. The instructor has twenty-six years of experience investigating and auditing misconduct and fraud cases. Case studies will be used to demonstrated time proven skills and techniques for the prevention of misconduct. Workshop Objectives: Attendees will be able to: 1. Apply legal standards to various types and forms of noncompliance to Good Clinical Practice (GCP) including domestic and international laws, regulations and guidance required by various governments. 2. Dissect misconduct and fraud cases for examples of both types and forms of misconduct and fraud. 3. Compare and contrast misconduct and fraud case studies. 4. Compare and contrast scientific and medical misconduct case studies. 5. Discern the similarities and differences in investigator and sponsor misconduct and fraud. 6. Apply proven monitoring and auditing skills and techniques used to prevent and detect misconduct and fraud. a. Skills and techniques i. Understanding Protocol ii. Data-Driven Trend Analysis iii. Risk-Based Approaches and Planning iv. Monitoring and Auditing Source and Data Skills and Techniques 7. Implement risk-based concepts and procedures to ensure risk mitigations and prompt identification for nonconforming performance and risk indicators.