Monitoring Clinical Drug Studies: Intermediate

Course Description

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.

Learning Objectives

• 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

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Elizabeth Weeks-Rowe, LVN, C.C.R.A.

Click here for complete trainer biographies

Course Outline

Day One

• 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

• 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

Interactive Activities

• The experienced Monitor’s simulation exercise
• Case studies in motivation and site management
• CAPA documentation critique

Registration Fees

Accreditation Information

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#: 0778-0000-24-005-L99-P. Released: 3/24. 

               Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.