Online Learning Center

Good Clinical Practice: Understanding the Basics


This course is the first entirely online course within the Online Learning Center. 

Try Module 1 of the Course for FREE!

See Details and Purchase Access to the Basic GCP Course


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: Principles of Good Clinical Practice (GCP)
    Module 2: FDA Regulation of Clinical Studies
    Module 3: GCP Regulations and Guidelines
    Module 4: Life Cycle of a Clinical Trial and Essential Documents
    Module 5: Clinical Study Roles and Responsibilities
    Module 6: Informed Consent Process
    Module 7: Safety Reporting
    Module 8: Investigational Product Accountability
    Module 9: Standard Operating Procedures (SOPs) and Internal Process 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:   2.69 GCP or non-GLP units for completion of all 14 modules
Learn more about the Registered Quality Assurance Professional credential.

Nursing CEUs: This provider (Society of Quality Assurance) is approved by the California Board of Registered Nursing, Provider Number 13498, for 10 contact hours for this online course.

Member Price:  $745.00
Nonmember Price:  $895.00

You can join SQA for just $10 more overall and receive the member 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 sqa@sqa.org. You have one year from date of purchase to complete the course.

See Details and Purchase Access to the Basic GCP Course

SQA members benefit from reduced rates for online training and many other professional development opportunities!


Your online education purchases may be accessed with the MY SQA EDUCATION button on the MY SQA page.


 




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