Good Clinical practice

Good Clinical Practice (GCP) is a quality standard which  is recognized all over the world. It is now recognized as an  ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GCP is required in the testing of pharmaceuticals.

This is an in-depth course that provides essential understanding of Good Clinical Practice according to ICH e6 and Food and Drugs regulations. Its different from many other short courses you find online lasting less than a day. Contact us if you want the shorter version of this course.

General information

In this course you will gain an in depth understanding of Good Clinical Practice (GCP). It is designed for  personnel interested in learning the GCP as it applies to the Canadian market place. Many similar courses do not help the students to relate their knowledge to regulations. In this course we emphasize the application of the principles of GCP to health Canada. This course will be relevant to:

• pharmaceutical regulatory affairs,
• Clinical Research associates,
• Clinical Research Coordinators,
• Clinical Research Auditors
• project managers,
• Quality control,
• Quality assurance
• Research and development personnel.
• Clinical Investigators

Learning Level: Basic and intermediate
Total Length of Course: 25 hours
Cost:CAD 585

Good Clinical Practice

This course is for individuals who want to understand and apply the Good Clinical Practice  in drug  development and related areas. A good command of English language and a basic understanding of chemistry and biology are recommended.

Good Clinical Practice

The following topics will be covered in this course.

• Introduction to GCP
• Sponsor
• Investigator
• Clinical monitor and IRB/IEC
• Clinical trial protocol and protocol amendments
• Investigator’s brochure
• Essential documents of a Clinical trial
• ICH GCP and Canadian Regulations

Good Clinical Practice

On completion of this course you will be able to do the following:

• Identify the major roles of each member of a clinical trial team
• Outline the responsibilities of each member of a clinical trial team.
• Describe the responsibilities of a clinical trial sponsor.
• Describe the responsibilities of a clinical investigator.
• Explain how the informed consent protects the welfare of study participants.
• Discuss the elements of the informed consent
• Describe the  role of the ethics boards in a clinical trial
• Describe the responsibilities of a trial monitor.
• Discuss the importance of essential documents
• Relate the principles of the GCP to the food and drug regulations

Good Clinical Practice

This course is Instructor-led and is delivered through our secure student friendly online Learning Management System.

Good Clinical Practice. There are 8 topics and Students will complete one quiz and one homework assignment per topic. Students will also be graded on forum participation in each topic. There will be one final course examination.

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