This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate – with a focus on developing tools and identifying challenges for effective monitoring. Industry standards and best practices will be discussed with an emphasis on the relationship between the Sponsor/CRO and the Investigator/site personnel. References and resources (including those available online) will be provided. Topics include site management, developing tools for effective monitoring, comonitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials and GCP principles.
- 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 more effectively in mentoring and co-monitoring assessments
- 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
- Prepare for monitoring challenges in a global clinical trial
- Prepare 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., C.C.R.A.
Gary B. Freeman, M.S., C.C.R.A.
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
Elizabeth Ronk Nelson, M.P.H.
Lily Romero, P.A., C.C.R.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Regulatory Recap – Practical Application of GCP: FDA regulations, guidance documents and ICH guidelines
- Monitoring and Co-monitoring, Monitoring Tools and Tracking Systems: Best Practices
- Successful Site Management: Influencing without authority, analyzing site performance problems; exploring root causes; corrective and preventive action plans (CAPA)
Day 2: 8:30 a.m. – 5:00 p.m.
- Problem Solving and Prioritizing Monitoring Challenges: Monitoring simulation
- Monitoring Challenges in Global Studies: Identify issues that may develop in studies that are conducted globally
- FDA Inspections and Site Preparation: ;Mechanics of an FDA inspection; FDA classifications; common deficiencies; possible restrictions; tips for helping sites prepare for an FDA inspection
- The experienced Monitor’s Simulation Exercise
- Case study in motivation
- Case study in site management
- How Can I Document This in a Follow-up Letter?
- CAPA documentation critique
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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-15-049-L01-P. Released: 8/15.
This continuing nursing education activity was approved by the New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation.
Approval Number: 7449-12/13-15. 14 Contact Hours
Participants will receive 14 hours of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.