Good Clinical Practice: Understanding the Basics
This course is the first entirely online course within the Online Learning Center.
This course is under review for updates and is not currently available for sale. We hope to have the course relaunched in 2026.
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
Target Audience: GCP auditors with zero to one year of experience and anyone who would like to learn the basics of GCP. This is a basic course.
Description: This is a basic course providing an overview of the fundamentals of Good Clinical Practice (GCP). The course addresses relevant US FDA regulations for GCP as well as guidelines from ICH and ISO. Some applied knowledge is provided through interactive review questions and quizzes, but advanced concepts are not within the scope of this training. It is delivered on-demand, at your convenience, in 14 modules.
Review the complete course objectives here.
Modules:
Introduction
Module 1: Primary Principles of Good Clinical Practice (GCP)
Module 2: FDA Regulation of Clinical Studies
Module 3: GCP Guidelines
Module 4: Lifecycle of a Clinical Trial and the Essential Documents
Module 5: Clinical Study Roles and Responsibilities
Module 6: The Informed Consent Process
Module 7: Safety Reporting
Module 8: Investigational Product Accountability
Module 9: Internal Audits
Module 10: Auditing Vendors for GCP Compliance
Module 11: Clinical Investigator Site Audits
Module 12: Hosting Regulatory Inspections
Module 13: Fraud and Misconduct
Module 14: ICH E6 Clinical Investigator Responsibilities
RQAP re-registration credit: 10.75 GCP or non-GLP units for completion of all 14 modules
Learn more about the Registered Quality Assurance Professional credential.
Member Price: $800.00
Nonmember Price: $960.00
University or Government Employee Price: $600.00*
Student or Outreach Member Price: $400.00
RQAP-credentialed professionals can use the code RQAP25OFF for an additional 25% discount.
*Please contact [email protected] to purchase this course at the University or Government Employee price.
Join SQA before purchasing this course and gain access to the $160 member discount. You'll receive both course access AND SQA member benefits for only $35 more than the original course price!
Policies: No refunds will be provided for this course under normal circumstances; under extenuating circumstances, the SQA Board of Directors may consider individual requests for refunds made in writing to
[email protected]. You have one year from date of purchase to complete the course.
Bulk Pricing: If you are interested in buying
five or more online learning programs (five seats in one course for your staff, five separate courses for yourself, or any combination thereof),
delivered in SQA's learning management system, please download our
Online Learning Bulk Order Form. (If you are interested in buying many seats in this course and/or would like it
delivered via your company's learning management system (rather than SQA's), please
view the course in the OpenSesame course catalog!)
This course is under review for updates and is not currently available for sale. We hope to have the course relaunched in 2026.
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SQA members benefit from reduced rates for online training and many other professional development opportunities!
Your online education purchases may be accessed by clicking/tapping "My Account" at the top of the site and selecting "My Online Courses & Recordings."