'Noncompliance Causalities and Securing Compliance at the Clinical Investigator'

Four hours of Education plus Research Assignments for Clinical Trial Auditors, Monitors Coordinators and Site Staff.

When developing strong compliance programs and increasing the skill level of clinical research professionals, we must seek to examine why noncompliance occurs within clinical trial operations. This course provides an understanding of the major trends of noncompliance within Clinical Investigator operations and presents the concept of effective Quality Systems.
In order to increase the awareness of noncompliance, Sponsors, Contract Research Organizations, Institutional Review Boards, and Clinical Investigators must understand their performance impact on the other organizations. This course introduces skills for ensuring Corrective and Preventative Action (CAPA) programs at the Clinical Investigator level. A complete CAPA System is provided.

Skill-Based Training Program Deliverables:

1. Recognize and implement the Quality Systems Method of Auditing and Monitoring
- Global Regulatory Focusing
- Risk Management
2. Recognize and implement critical systems focusing
3. Recognize leading and lagging systems indicators
4. Recognize the lack of Quality Impact at the Clinical Investigator
5. Examine top level causalities of noncompliance at the Clinical Investigator:
- Upper Management Impact
- The Monitoring Role
- Lacking Corrective and Preventative Actions
- CRO Oversight
- Clinical Investigator Impact
- IRB Outreach
- Clinical Data Failures
6. Examine the overlapping law principles in 21 Code of Federal
7. Recognize the principle of regulatory case development
8. Develop auditing and monitoring skills for securing compliance
9. Learn how to implement a complete Corrective and Preventative Actions (CAPA)Program
10. Examine global recommendations for correcting Clinical Trial noncompliance

4 hours of Education for Clinical Trial Auditors, Monitors, Coordinators and Site Staff.
4 Contact Hours or 0.4 CEUs
$175.00