Managing compliance in the research industry is critical to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, 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. Millions of dollars and countless hours are wasted every year on ineffective interventions because of inaccurate and/or inadequate issues management and root cause analysis. This course will present the concepts of root cause analysis and apply them specifically in the clinical trial setting. Root cause analysis is invaluable for all stakeholders in clinical research including the sponsor, CRO, investigator/site, and IRB/IEC.
The corrective action process including, when appropriate, preventive action planning, should be implemented when RCA has been completed. Effective corrective action planning includes many important steps that lead to promoting improved performance for the study and for future activities. Most importantly, effective CAPA 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.
Define investigator and site non-compliance
Describe performance management concepts and skills for effective site risk management to promote prevention of performance issues and to ensure adequate site issues management
Implement Gilbert’s Root Cause Analysis Diagnostic Process
Apply performance management concepts in case studies with a focus on preventive and issues management scenarios
Recognize components of effective Corrective Action Planning
Identify examples of Corrective Action Planning application for different levels of site non-compliance case scenarios
Discuss successful Preventive Action Planning and implementation
CRAs
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:
Karen Gilbert, B.S., C.C.R.A.
Lily Romero, P.A., C.C.R.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Performance Management Concepts for effective site risk management to promote prevention of performance issues and to ensure adequate site issues management. Factors that promote positive performance of research sites from pre-study through close-out
- Define Investigator Non-Compliance: Human subject protection; data integrity; investigational product; PI oversight
- Issues Management when deficiencies are identified: Evaluate and determine if a true issue exists; communication with stakeholders; when re-training is not the only solution; timely evaluation of effectiveness
- Root Cause Analysis (RCA): Timely; accurate and complete; intervention; evaluation
Apply Performance Management Concepts in case scenarios representing preventive and issues management examples. Scenario of CRA identification of site qualification issues (i.e. staffing, subject availability); scenario of CRA identification of site not performing per expectation (i.e., lack of enrollment, staffing)
Day 2: 8:30 a.m. – 5:00 p.m.
- Corrective and Preventive Action (CAPA) Concepts: Evaluate deficiencies and determine if issue requires short or long term solution; communication; training, re-training, and education; enforcing standards; internal and external oversight; timely response to identification of problems; timely evaluation of effectiveness of process
- Identify Examples of Corrective Action Planning application for different levels of site non-compliance case scenarios: Scenario: site non-compliance (i.e., inappropriate investigator delegation and ICF); apply the steps of CAPA; ensure the interventions are linked to root cause; identify when short term (case specific) and long term (systems improvement) should be utilized
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 Elizabeth Andrews 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# 0778-0000-11-034-L01-P. Released 3/11.
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For more information, contact Naila Ganatra at (215) 413-2471.