Good Clinical Practices (GCPs)

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