Good Clinical Practice - Two Day

The two-day Good Clinical Practice (GCP) course is an intensive training course - worth 16.5 contact hours/credits  - designed to boost knowledge and understanding of good clinical practice. Whether you are a clinical research physician, investigator, study coordinator or other member of the study team, this course will provide you with the intensive training needed to improve your trials and ensure compliance with GCP, FDA Regulations, and ICH Guidelines.

Two-day GCP courses are now being offered as blended learning programs with both classroom and e-learning components. Course attendees are required to complete the online GCP course modules prior to attending the classroom portion of this course. Specific course information will be provided to attendees upon registration for blended learning programs.

Upcoming Dates & Locations

• San Diego, June 21-22, 2008
• Arlington, Va., Oct. 25-26, 2008

Course Objectives

At the conclusion of the Good Clinical Practice course, participants should be able to:

• Review the evolution of Good Clinical Practice, from its origins to currently acceptable standards and the imperative of keeping abreast of changing practices and regulations.
• Define the major steps and phases of the drug development process.
• Describe the main regulations governing the practice of clinical research and other applicable guidelines, including the EU Directive, FDA CFR, Data Privacy/HIPAA, and ICH.
• Examine the legal, professional and ethical constraints on various clinical research processes, such as the management of informed consents, IRB/IECs, disclosures of financial interests and electronic signatures.
• Identify the tools and techniques for successfully managing and executing trials.
• Analyze the international principles of ethical conduct and subject protection together with examples of acceptable and non-acceptable norms.