Managing investigator noncompliance in the research industry is critical to successful clinical trials. Regulatory authorities expect that all stakeholders identify noncompliance, correct the non-compliance 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 non-compliance, 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. The concepts covered are invaluable for allstakeholders in clinical research including the sponsor, CRO, investigator/site, and IRB/IEC.
- Define investigator and site non-compliance
- Describe performance management concepts and skills for effective site risk management
- Promote 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
- Project Managers/CRA Managers
- Principal Investigators
- Site Research Directors/Managers
- Clinical Research Coordinators
- QA staff
The course will be led by one of the following instructors:
Lily Romero, P.A., C.C.R.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- 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 2: 8:30 a.m. – 5:00 p.m.
- 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
- Case studies applying each of the performance management concepts
- Individual case studies (based on actual FDA warning letters) are assigned to each participant to practice and apply
- Identification of noncompliance
- Questions to ask to determine the root cause
- Identification of necessary corrective actions
- Identification of necessary preventive actions
- Documenting the issue in monitoring reports and correspondence
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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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 mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-14-011-L01-P. Released 3/14.
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For more information, contact Naila Ganatra at (215) 413-2471.