GCP 2: Good Clinical Practice, Level 2

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Program/Course ID: GCPR2 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: INTRODUCTION 1. Course Information 2. Interface Tour 3. Course Overview STUDY START-UP:RESPONSIBILITIES 4. Objectives 5. GCP Guidelines 6. Investigator`s Responsibilities 7. Sponsor`s Responsibilities 8. Recordkeeping for Investigators 9. Recordkeeping for Sponsors and Monitors 10. The Evaluation Visit 11. Progress Check STUDY START-UP: PROTECTION OF SUBJECTS 12. Objectives 13. Purpose of IRBs 14. Investigator-IRB Relationship 15. IRB Records and Reviews 16. Informed Consent: General Requirements 17. Informed Consent Process 18. The Informed Consent Document 19. Progress Check DURING THE STUDY 20. Objectives 21. Investigator`s Responsibilities 22. Recordkeeping for Investigators 23. Investigator-IRB Interactions 24. Handling Investigational Product 25. Managing Adverse Events 26. Regulatory Evaluations 27. Progress Check AFTER THE STUDY 28. Objectives 29. Preparing for an Audit 30. Record-keeping 31. Disqualification 32. Progress Check		Objectives: Explain the role GCP plays in ensuring subjects are protected. List the investigator and sponsor`s responsibilities prior to study start-up. Describe the documents found in a study file. Explain the purpose of the evaluation visit. List the functions of Independent Review Boards (IRBs or IECs). Describe the investigator-IRB interaction. Explain how informed consent is achieved. List the essential elements of the informed consent document. List the investigator`s ongoing responsibilities during a clinical trial. List the documents maintained during a clinical trial. Describe the interactions between an investigator and IRB once the clinical trial has commenced. Explain how the investigator maintains accountability of the investigational product. Describe how adverse events are recorded and reported. Explain what is meant by a `complete` record. Describe the types of records that must be kept following NDA approval, or the termination of a clinical trial. Describe the process of disqualification.

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Comments: For quotes or invoices please provide the titles of the course(s) and number of students.	GCP 2: Good Clinical Practice, Level 2