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GCP 1: Good Clinical Practice, Level 1
Description: Good Clinical Practice (GCP) refers to a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects. GCP compliance ensures the protection of the rights, safety, and well-being of trial subjects and the credibility and integrity of clinical trial data. This course reviews clinical trials, GCP guidelines and informed consent.
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COURSE OUTLINE
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
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COURSE OBJECTIVES
Students completing this course should be able to:
- 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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SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.
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