This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate - with a focus on developing tools and identifying current industry trends and challenges for effective monitoring. FDA/Regulatory Authority inspection findings will be used throughout the seminar to emphasize critical areas in monitoring and managing site compliance. Industry standards/best practices will be discussed with an emphasis on the Sponsor/CRO-Site/Subject relationship. References and resources (including those available online) will be provided. Topics include site management, developing or identifying and modifying tools for effective monitoring and co-monitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials such as adverse event reporting and managing non-compliant or underperforming sites.
- Describe various sponsor interpretations of FDA regulations and practical application of ICH guidelines
- Discuss current trends in clinical research
- Evaluate and develop more efficient study tracking and management tools
- Participate in monitoring/co-monitoring assessments
- Prepare for monitoring challenges in a global clinical trial
- Effectively manage your sites, and ensure their optimum performance
- Identify strategies for managing issues including root cause analysis and corrective action and preventive action plans
- Implement techniques for training and mentoring the research team
- Prepare your sites for an FDA/Regulatory Authority inspection
- Experienced Clinical Research Associates and Medical Research Associates with more than 2 years experience seeking to update their knowledge of the GCP regulations and guidelines and fine tune their site management and monitoring skills.
- Clinical research professionals involved in the management of CRAs, and/or study/project management.
The course will be led by one of the following instructors:
Nikki Christison, B.S.
Karen Gilbert, B.S., C.C.R.A.
Gary B. Freeman, M.S., C.C.R.A.
Elizabeth Ronk Nelson, M.P.H.
Lily Romero, P.A., C.C.R.C.
Jackie Stader, C.O.T., C.C.R.C
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Day 1: 8:30 a.m. – 5:00 p.m.
- Regulatory Recap – Practical Applications of GCP: FDA regulations, guidance documents and ICH guidelines
- Monitoring and Co-monitoring, Monitoring Tools and Tracking Systems: Best Practices Reports, follow-up letters, and documenting challenging monitoring situations
- Monitoring Challenges in Global Studies: Identify issues that may develop in studies that are conducted globally
- Successful Site Management: Analyzing site performance problems; exploring cause factors; identifying solutions; site performance incentives
Day 2: 8:30 a.m. – 5:00 p.m.
- Problem Solving and Prioritizing Monitoring Challenges: Monitoring simulation
- FDA/Regulatory Authority Inspections– A Comprehensive Discussion: Mechanics of an FDA inspection; FDA classifications; common deficiencies; possible restrictions
- Preparing Sites for a Sponsor Audit or FDA Inspection: Tips for helping sites prepare for an sponsor audit or regulatory inspection
- Group Discussion on the Different Interpretations of FDA Regulations and ICH Guidelines for GCP
- The experienced Monitor's Simulation Exercise
- Sponsor-CRO-Site Interactions (Problem Solving)
- Site Performance
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# 0778-0000-12-046-L01-P. Released: 8/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.