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, 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 and GCP principles.
- Describe various sponsor interpretations of FDA
regulations and practical application of the ICH GCP E6 Guideline
- Discuss current trends in clinical
- Evaluate and develop more efficient
study tracking and management tools
- Identify more effective mentoring
and CRA assessments
- Manage your sites more effectively
and ensure their optimum performance
- Identify strategies for managing
issues including root cause analysis and corrective and preventive action
- Prepare for monitoring challenges in
a global clinical trial
- Prepare sites for an FDA/Regulatory
- Experienced Clinical Research Associates and
Medical Research Associates with more than two years of 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 Clinical Research Associates, and/or
The course will be led by one of the following
Gary B. Freeman, M.S.
Marla Hoelle, R.N., B.S.N.,
Lily Romero, P.A., C.C.R.C.
Elizabeth Ronk Nelson,
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Day One: 8:30 a.m. – 5:00 p.m.
- Regulatory Recap and Update: Application of GCP: FDA regulations, guidance
documents and the ICH GCP E6 Guideline
- Monitoring and CRA Assessment, 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)
Two: 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
- 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 studies in motivation and site
- CAPA documentation critique
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#: 0778-0000-18-006-L01-P.
The New Jersey State Nurses Association is accredited by the ANCC Commission on Accreditation of the American Nurses Association as an approver of continuing education for nursing. As an accredited body, NJSNA has approved this program for: Contact hours competed: 12.75 Approval Number: 7895-1/19-21
this course at your company! For more information, contact Naila Ganatra at +1