Monitoring Clinical Drug Studies: Advanced

Upcoming Courses

Course #: SSAB0614
June 3-4, 2014
Metro Meeting Centers - Boston
Boston, MA
Take advantage of our $1,595.00 price by registering early!
* After May 2, costs are $1,795.00.

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 the 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 
  • Understand 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 

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

Linda Carter, R.N., B.S.N.
Nikki Christison, B.S., C.C.R.A.
Gary B. Freeman, M.S., C.C.R.A.
Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies  

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • Regulatory Update: The latest FDA regulations 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 
  • Managing Stakeholders: Developing and communicating realistic expectations; reaching stakeholder agreement 

Day 2: 8:30 a.m. – 5:00 p.m. 

  • Site Management (Performance) 
  • Identifying, Reporting and Managing Study-Specific Issues/Corrective and Preventive Action 
  • 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

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

ACPE LogoBarnett 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 mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-12-003-L01-P. Released: 1/12. 

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471. 


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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.

GCP for Investigators

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 

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