Course Description

Managing investigator noncompliance in the research industry is critical to successful clinical trials. Regulatory authorities expect that all stakeholders identify noncompliance, correct the noncompliance through intervention, and evaluate the effectiveness of the intervention. Root cause analysis provides a process through which issues can be accurately identified and interventions can be effectively designed. The corrective action process including, when appropriate, preventive action planning, should be implemented when RCA has been completed. An effective CAPA process can lead to improved human subject protections and confidence in the integrity of the data. Lack of effective corrective action management can lead to repeated noncompliance, compromised subject safety, poor data quality, and/ or unacceptable inspection findings with subsequent negative impact on the final submission. This course focuses specifically on the management of noncompliance issues occurring at investigative sites.

Learning Objectives

• Define investigator and site noncompliance
• Describe performance management concepts and skills for effective site risk management
• Integrate prevention of performance issues and ensure adequate site issues management
• Implement Gilbert’s Behavioral Engineering Model for a diagnostic root cause analysis process
• Apply performance management concepts in case studies with a focus on prevention and issues management
• Recognize components of effective corrective action planning and documentation
• Identify examples of corrective action planning for different site noncompliance case scenarios
• Discuss successful preventive action planning and implementation

Who Should Attend

• Clinical Research Associates, Project Managers and Clinical Research Associate Managers
• Principal Investigators, Site Research Directors and Coordinators
• Quality Assurance Staff

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies

Course Outline

Day One

• Defining Investigator Noncompliance: Regulatory definitions and categories
• Performance Management Concepts: Theories of motivation, taking a risk-based approach to monitoring, issues escalation and management
• Root Cause Analysis: Detailed examination of Gilbert’s Behavioral Engineering Model and its application to root cause analysis
• Application of Root Cause Analysis Concepts: Behavioral interviewing, the 5 Why’s, and open-ended questions

Day Two

• Application of Performance Management Concepts: 7 Comprehensive compliance management steps
• Corrective and Preventive Action Plans (CAPA) – Concepts and Examples: Problem solving and implementing both short-term corrective and long-term preventive actions
• Documenting Investigator Noncompliance: Linking noncompliance to regulatory requirements; documentation best practices
• Exercises in Concept Application: Review and critique of simulated monitoring reports documenting noncompliance and CAPA

Interactive Activities

• Individual case studies (based on actual FDA warning letters) are assigned to each participant to practice and apply
• Identification of noncompliance and Questions to ask to determine the root cause
• Identification of necessary corrective and preventive actions
• Identification of necessary preventive actions
• Documenting the issue in monitoring reports and correspondence

Registration Fees

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-057-L99-P. Released: 10/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.