#Barnett
Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
Monitoring Clinical Drug Studies: Advanced
Upcoming Courses
This course will be offered from 9:00 a.m. - 4:00 p.m. Eastern
Course Description
This course will focus on more complex and challenging issues affecting the Clinical Research Associate with management/leadership responsibilities. Current hot topics and trends will be discussed. Participants will analyze case studies to identify how monitors/study leaders could have identified, managed, and followed up on under performance or non-compliance issues. Corrective and preventive action plans (CAPA) will be developed as part of the course activities. Training and mentoring techniques will be included to assist training/mentoring sponsor/CRO and site staff.
Learning Objectives
- Explain the most recent regulations and guidance documents that govern clinical research
- Discuss current issues that affect clinical monitoring
- Describe effective mentoring techniques
- Discuss ways of assessing monitor skills
- Develop techniques to manage stakeholders
- Define techniques to promote successful site management
- Identify, manage, and report study-related issues
- Describe how to manage situations involving fraudulent data
- Discuss FDA’s BIMO program for sponsor and investigator inspections
Who Should Attend
- CRAs with management responsibilities that include mentoring and assessing monitoring skills and complex issues involving site management, study management, sponsor/ CRO challenges
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 Update: The latest FDA Guidances will be reviewed
- Monitoring Visits Update: Risk-Based Monitoring Approach
- Monitoring Plans: Writing, evaluating, implementing, and assessing effectiveness
- Mentoring, Communication, and Negotiating Skills: Tips for making the most of “mentoring” opportunities
- Co-Monitoring/Assessing Monitoring Skills: Techniques for assessing monitors in the Sponsor/CRO environment
Day Two
- Managing Stakeholders: Developing and communicating realistic expectations; reaching stakeholder agreement
- Site Management (Performance)
- Identifying, Reporting and Managing Study-Specific Issues/Corrective and Preventive Action Plans
- Managing Situations Involving Fraudulent Data
- Regulatory Compliance: Discussion of sponsor and investigational site inspections by FDA; current information regarding FDA and regulatory authority inspections/audits; practical tips for preparing your site for an audit
Interactive Activities
- Reviewing Reports and Study Documentation
- Case Studies/Scenarios: Assessing Monitoring Skills, Site Issues, Stakeholder Relations
- Detecting Fraudulent Data
Registration Fees
Special rates are available for multiple attendees from the same organization. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.
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#: 0778-0000-24-006-L99-P. Released: 3/24.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.