Who Should Attend

This course is specifically designed for Clinical Research Monitors (CRMs), Clinical Research Auditors and others who need basic and expanded knowledge in FDA and ICH Regulations for Good Clinical Practices (GCPs).  This three-day program will provide attendees with the training needed to improve clinical trials and ensure compliance with Good Clinical Practice, FDA Regulations, EU Directives and ICH Guidelines.

Clinical Research Managers who oversee and instruct CRMs and CRAs will gain insight in how to best train these employees and how this information can be used for in-house refresher courses.  Other research professionals, i.e., clinical investigators, research coordinators, regulatory and medical communications personnel will also benefit from this GCP program.
 


Learning Objectives

Upon completion of this course, each participant will have a thorough understanding of GCPs dictated by FDA and ICH Requirements for Sponsors, Monitors, and Investigators.  In addition, the significance of these regulations will be correlated to protocol and case report form development for all phases of clinical research.  Information regarding in-field and in-house auditing (i.e., Quality Assurance (QA) procedures compared to FDAs Bio-monitoring system) will be presented.  Investigational Review Boards (IRBs) and Informed Consent (IC) as required by the FDA and ICH regulations are discussed in detail and are compared with GCP and ICH regulations.

Course Description

This is a three-day course designed to provide individuals with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as, regulatory requirements.  The course consists of lecture and exercises.   Participants will also be placed in several real life situations such as reviewing pre-study documents and informed consent forms for completeness and compliance; conducting drug accountability; reviewing case report forms for accuracy and adherence to protocol and performing source document verification.

The course is designed to provide the attendee with thorough knowledge of the following topics:

• How drugs are discovered and developed for marketing approval
• The four different study phases of  clinical research
• What constitutes Good Clinical Practices (GCP)
• The principles of ICH GCP
• The IRB/IEC’s composition and role/responsibilities
• The IRB study review & approval process
• The role and responsibilities of the investigator & study site staff
• The role and responsibility of the sponsor
• The history of the FDA and their role & responsibilities
• Which sections of 21 CFR govern conduct of clinical studies
• The purpose for an IND and its composition
• How INDs are filed, reviewed, approved & amended
• The IND reporting requirements
• The requirements for Informed Consent
• How to review an Informed Consent form for compliance
• The process for Informed Consent review & approval
• The administration of subjects Informed Consent
• The different types of study Monitoring visits & tasks for each
• Adverse Events - the types and reporting requirements
• How to perform Drug Accountability & compliance
• How to manage study supplies
• How to detect and deal with Fraud
• The purpose and composition of the NDA
• How NDAs are filed, reviewed and approved
• Sponsor responsibilities after approval
• How to review study documents & determine compliance
• How to review Case Report Forms and determine adherence to protocol
• How to perform Source Document Verification

View Course Agenda



Past Participant's Comments:

“The three days flew by!  A very well organized course, very interactive between the instructor and students.  The Course Director was an un-ending source of information and real-life experience.  I wouldn’t change anything…keep up the good work!  I am definitely going to promote this course to others.”
Natalie B., Clinical Trial Associate, Grunenthal GmbH

"CfPIE has become the gold standard of training providers.  I've sent most of my department to this program.  It's far better than courses we've attended with other training companies and the Course Note Material is very well put together.  I see our employees referring to it time and time again.  It's a pleasure to work with an organization that takes such pride in the training they deliver."
Dr. Richard P., Director, Pfizer

"This was the most comprehensive course I've attended.  You did a great job in covering a lot of important material in three days." 
Dan R., Research Associate, Wyeth

"This is my third CFPIE course and each one has been very well organized.  After attending this course, we decided to bring the training in-house for our new hires.  The instructor was superb and joked about the lengthy process he had to go through to be chosen by the Center.  They have the best trainers in the business." 
Senior Clinical Manager, Shire Labs

"The Director was a great and informative instructor.  He was fresh and innovative.  I would definitely love to have him again as an instructor."
Anita O., Contract & Budget Analyst, Celgene

"Excellent course!  A comprehensive, worthwhile review of GCP concepts.  Plenty of new revelations and real-world examples/exercises.  The scope is applicable to all levels of experience.  I highly recommend it to anyone involved in clinical research."
John R., Project Manager, Ivress, LLC

"Exercises were very helpful in understanding material and applying in practices."
Quality Assurance, Schering Plough

"Very practical orientation - we could directly apply the info to our daily work.  We appreciate your approachable, cooperative attitude - you appealed equally to the most and least experienced."
Cris H., Biosynexus