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Training Courses - Core Cirriculum

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

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.

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.

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

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

This course is for individual registrants only and does not allow for group training.

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.

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#: 0778-0000-21-030-L04-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 completed: 12.75 Approval Number: 7964-6/21-23 

 

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