Monitoring Clinical Drug Studies: Intermediate

Upcoming Courses

Course #: SSID0514
May 6-7, 2014
Courtyard San Diego Downtown
San Diego, CA

Course #: SSIB0614
June 25-26, 2014
Metro Meeting Centers - Boston
Boston, MA
Take advantage of our $1,595.00 price by registering early!
* After May 23, costs are $1,795.00.

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, comonitoring 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 ICH guidelines 
  • Discuss current trends in clinical research 
  • Evaluate and develop more efficient study tracking and management tools 
  • Participate more effectively in mentoring and co-monitoring assessments 
  • Effectively manage your sites, and ensure their optimum performance 
  • Identify strategies for managing issues including root cause analysis and corrective action 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 2 years 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 CRAs, and/or study/project management. 


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.
Elizabeth Ronk Nelson, M.P.H.
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 Recap – Practical Application of GCP: FDA regulations, guidance documents and ICH guidelines 
  • Monitoring and Co-monitoring, 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 2: 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 study in motivation 
  • Case study in site management 
  • How Can I Document This in a Follow-up Letter? 
  • 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

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# 0778-0000-12-046-L01-P. Released: 8/12. 

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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 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)