Barnett International's Core Curriculum courses are comprehensive role-based training programs designed to provide participants with hands-on, in-person training. Held four times a year during Barnett’s “Clinical Research Training Weeks,” courses take place at state-of-the-art corporate meeting centers or in centrally located hotels on the East and West Coasts of the U.S., and offer focused, performance-based training and employee development.
Monitoring Clinical Drug Studies: Intermediate
This course offering will take place live via WebEx from 12:00 PM – 7:00 PM Eastern each day. Participants will receive an email confirmation that includes the seminar link to enter the meeting room as well as the audio connection information.
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, co-monitoring assessments, monitoring plan development best practices, 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 research
- 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 plans (CAPA)
- Develop effective monitoring plans and best practices
- Prepare sites for an FDA/Regulatory Authority inspection
- Describe how FDA/Regulatory Authority assess sponsor monitoring during inspections
Who Should Attend
- 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 study/project management
The course will be led by one of the following instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A., ACRP-PM., P.M.P.
Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.
Elizabeth Ronk Nelson, M.P.H.
Lily Romero, P.A., C.C.R.C.
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)
Day Two: 8:30 a.m. – 5:00 p.m.
- Monitoring Plan Development and Best Practices
- Problem Solving and Prioritizing Monitoring Challenges: Monitoring simulation
- 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 management
- 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.
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#: 0778-0000-21-004-L01-P. Released: 3/21.
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
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.