This course, brought to you by the SQA Learning Foundation, is for GCP auditors with zero to one year of
experience and anyone who would like to learn the basics of GCP. It is designed to provide an overview of the fundamentals of Good Clinical Practice. The course addresses relevant US FDA regulations for GCP as well as guidelines from ICH and ISO.
Some applied knowledge is required to work 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. Each module will deliver information to you, let you self-assess your knowledge with review questions
interspersed throughout the module, and will culminate with a quiz at the end of each module. You will be able to access the course certificate after completing
all of the modules, passing the quizzes with a 70% average or higher, and submitting the course evaluation. For the modules included in this course, please see the list below.
For the learning objectives for the modules, please click here.
- 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
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.
RQAP re-registration credit: 2.69 GCP or non-GLP units for completion of all 14 modules.
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.
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 firstname.lastname@example.org. You have one year from date of purchase to complete the course.