Good Clinical Practices

This course is specifically designed for Clinical Research Monitors (CRMs) and Clinical Research Auditors (CRAs) and others who need basic and expanded knowledge in FDA and ICH Regulations for Good Clinical Practices (GCPs). This three-day program will provide you with the training needed to improve your 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 comprehensive knowledge and 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. Detailed infield and in-house auditing i.e., Quality Assurance (QA) procedures compared to FDAs Bio-monitoring system will be thoroughly presented. Investigational Review Boards (IRBs) and Informed Consent (IC) as required by the FDA and ICH regulations are detailed and correlated 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, roles and responsibilities of the key players and regulatory requirements. The course consists of lecture and imbedded exercises. Participants will also be placed in several real life situations such as reviewing pre-study documents and informed consent form 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
• About 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
• About 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
• About the 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

________________________________________

COURSE AGENDA

DAY 1

Introductions & Agenda Review - 9:00am – 9:30am

The Drug Development Process - 9:30am – 10:30am

• What is a drug
• How are drugs developed
• Phases of clinical development
• Exercise

Good Clinical Practice (GCP) – 10:45am – 12:30pm

• Principals of GCP
• Role of IRB/IEC, sponsor, investigator
• Exercise

Lunch – 12:30pm – 1:30pm

Regulations – 1:30pm – 2:30pm

• History of Regulations
• 21 CFRICH Guidelines
• Role of FDA
• Exercise

IND – 2:00pm – 2:30pm

• Definition
• Composition
• Types of INDs
• Review & amendment process
• Exercise

IRB/IECs – 3:30pm – 4:30pm
• Description, composition & role
• Study review and approval process
• Exercise

Recap, Questions and Answers – 4:30pm - 5:00pm

DAY 2

Informed Consent – 9:00am – 10:30am

• Elements
• Process
• Common errors
• Review, approval, amendments
• Exercise

Monitoring – 10:45am – 11:30am

• Definition
• Types of monitoring visits & tasks
• Role of the CRA Exercise

Adverse Events – 11:30am – 12:30pm

• Definitions
• Documenting
• Reporting
• Exercise

Drug Accountability – 1:30pm – 2:45pm

• Definition
• Managing clinical supplies
• Compliance
• Exercise

Fraud Types of fraud - 2:45pm – 3:30pm

• Detecting fraud
• Examples
• Exercise

NDA – 3:45pm – 4:30pm

• Definition
• Content
• Review & approval process
• Exercise

Recap, Questions and answers – 4:30pm – 5:00pm

DAY 3

Post Drug Approval – 9:00am – 9:30am

• Reporting requirements
• Phase IV
• Course Review

Course Review – 9:30am – 10:30am

Monitoring Simulation – 10:45pm - 12:30pm

• CRF Review
• SDV
• Review & Discussion of Monitoring Simulation

Monitoring Simulation – 1:30pm – 2:30pm

Review and Discussion of Monitoring Simulation – 2:30pm – 3:30pm

Recap, Questions and Answers – 3:45pm – 4:15pm

Course Evaluation – 4:15pm – 4:30pm