Course Description

Introduction to Good Clinical Practice

Course Description:

This introductory course to Good Clinical Practices(GCP) will take you directly into the fundamental elements and objectives of GCP to illustrate why and how these are enforced throughout every stage of a clinical investigation.

You will also be introduced to the major requirements outlined within the Declaration of Helsinki and be pointed to the applicable documents laying out the rules of medical device good clinical practices as per ISO 14155, 21 CFR part 812, 50 and 56 and Japanese ICH for medical devices.


Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Define the basic elements and objectives that compose Good Clinical Practice.
  • Comprehend in detail the requirements as outlined in the Declaration of Helsinki.
  • Understand which rules and regulations stipulate GCP requirements worldwide.

Who Should Enroll:

Monitors/clinical research associates, clinical investigators, study coordinators.

Quality assurance, regulatory, sales and marketing professionals, wanting to understand the basic requirements of Good Clinical Practice.


Prerequisite Knowledge/Requirements:

Understanding the history of Good Clinical Practice is an advantage before taking this course.


Subject Matter Expert:
Danielle Giroud

Duration:
45 min

Release date:
09/30/2009

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 90.00
Premium Account: € 68.00

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