GCP 1: Good Clinical Practice, Level 1
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Download 2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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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Free Trial CoursesOutline:INTRODUCTION 1. Course Information 2. Interface Tour 3. Course Overview CLINICAL TRIAL OVERVIEW 4. Objectives 5. What is a Clinical Trial? 6. What is a Protocol? 7. What is Informed Consent? 8. Types and Phases 9. Benefits and Risks 10. Progress Check GCP GUIDELINES AND PRACTICE 11. Objectives 12. Choice of Control Group 13. Selection of Protocol 14. Protection of Subjects 15. Investigator`s Responsibilities 16. Sponsor`s Responsibilities 17. Record Keeping 18. Statistics and Calculations 19. Progress Check MONITORING AND ENFORCEMENT 20. Objectives 21. Monitoring 22. Regulations 23. Evaluation 24. Disqualification 25. Progress Check INSTITUTIONAL REVIEW BOARDS 26. Objectives 27. Purpose of IRBs 28. IRB Assurance 29. IRB Membership 30. IRB Regulations and Procedures 31. IRB Records and Reviews 32. Progress Check Informed Consent 33. Objectives 34. General Requirements 35. Informed Consent Process 36. Informative Elements 37. Types of Informed Consent 38. Progress Check | Objectives:Define the purpose of a clinical trial and the different types of clinical trials. Distinguish the four clinical study phases in terms of size, duration, and objectives. Explain why a study protocol is important. Define informed consent. List the questions that a prospective study participant must know the answers to before informed consent can be given. List the factors involved in the formulation of inclusion/exclusion criteria for participation in a clinical trial. Name the components of a trial protocol and the issues they should address. Describe the ways in which an ethics committee can ensure protection of the rights of human subjects during review of a clinical trial. Describe the responsibilities of the investigator in ensuring the safety of the study subjects. Describe the responsibilities of the sponsor in ensuring compliance with regulatory requirements. Name the factors to be considered in selecting study monitors. Know the regulations concerning the function of monitors and where they can be found in the Code of Federal Regulations. Describe the purpose of the monitor`s preinvestigation visit, periodic visits, and record reviews. Name the elements of an on-site visit record. Describe the grounds for disqualification of investigators from receiving investigational drugs or devices for testing. Describe the purpose of IRB review. Explain the assurance mechanisms and how the HHS and FDA implement them. Describe the regulations for maintaining diversity in IRB membership. Describe the general IRB procedures for standard review, expedited review, emergency use protocols, informed consent review, document review, and continuing review. List the principles that apply to the informed consent process. Describe the key concepts that must be considered in selecting an informed consent process. Describe the procedures involved in obtaining informed consent. Name the essential elements of an informed consent document. Name the types of informed consent, the conditions under which they apply, and conditions for waiver of consent. | |
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