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, 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.

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
Prepare for monitoring challenges in a global clinical trial
Prepare sites for an FDA/Regulatory Authority inspection

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:

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM, P.M.P.

Janet Ellen Hoelle, 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.

Click here for complete trainer biographies

Course Outline

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.

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

Interactive Activities

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

Registration Fees

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.

Click here for our seminar cancellation policy

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#: 0778-0000-18-006-L01-P. Released: 2/18.

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.