'Conducting A Clinical Investigator Qualification Visit'

This course will focus on decreasing the incidents of selecting inappropriate Clinical Investigators for research, while also providing tools to Investigator Sites for assessing their readiness for research. Understanding the monitoring function is vital for ensuring compliance during the conduct of clinical trials. Monitors are responsible for recommending qualified Clinical Investigators for study conduct. The successful Investigator operates within legal and regulatory agreements. This course is designed to increase the Monitor’s skills for identifying compliance concerns ‘upfront’ in the monitoring process to prevent noncompliance issues that can impact clinical objectives. Monitors have to be taught skills for understanding how to inspect an Investigator’s facility as well as how to increase their interviewing skills. The program is taught by Tamera Norton Smith, Ph.D., President, Norton Audits, Inc. former award winning FDA Investigator and current trainer at the FDA and National and International Instructor.

Professionals that work in an enforcement, regulatory, or quality field know that success is designed ‘in front of the process’ and not at the end. When interviewing Monitors and Auditors, even beginning career professionals can accurately describe the traits of a successful Investigator. During Qualification Visits, Monitors can accurately define a successful Investigator as: involved in all aspects of their operation, a therapeutic and research expert, experienced, eager and excited, well staffed, and having a properly functioning facility designed to support the research infrastructure.

This program is appropriate for Monitors at all levels of experience that need training on inspecting and selecting Clinical Investigators, Project Managers, Quality and Compliance Auditors, Institutional Review Board Members, and Executive Management of Sponsor and Contract Research Organizations. Investigator Site personnel will also benefit from this program through learning a means to assess their own research capabilities. Following this program could change your organization and empower your research team to prevent noncompliance before the first data point is ever collected.

Monitors will be taught skills for:
1. Inspecting medical and research facilities
2. Effective interviewing skills of the research team including questions to ask and how to ask them
3. Ensuring protection of human research subjects and the clinical protocol outcomes
4. Performing operational quality systems evaluations
5. Assessing the clinical team’s training and experience
6. Pertinent regulations are presented to help the clinical research professional understand the legal requirements of their position
7. Detailed discussion of the investigator’s commitments on the Form FDA 1572, Statement of Investigator is expalined
8. A detailed examination with monitoring tools is provided for assisting monitors to stay focused in evaluating potential risks

3 hours of Education for the Clinical Research Monitor/CRA, Auditor, Investigator, and Coordinator.
3 Contact Hours or 0.3 CEUs
$125.00