GCP 1: Good Clinical Practice, Level 1

Duration: 3 Hours

Certificate of Completion:

Provided immediately upon successful completion.

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.

Accreditation: GeneEd designates this educational activity for a maximum of 3 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. This credit may also be applied to the CMA Certification in Continuing Medical Education.

GeneEd, Inc. is accredited by the Institute for Medical Quality/California Medical Association (IMQ/CMA) to provide continuing medical education for physicians. GeneEd, Inc. takes responsibility for the content, quality and scientific integrity of this CME activity.

In addition to physicians, GeneEd Online Training Courses are also applicable for nurses (RNs), doctors (MD and PhDs), clinical research associates (CRAs or monitors), clinical research coordinators (CRCs), investigators, researchers, bioprocess / biomanufacturing workers, QA/QC managers, other healthcare professionals and for patient education.

GCP 1: Good Clinical Practice, Level 1

OUTLINEINTRODUCTION

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: Students completing this course, GCP 1: Good Clinical Practice, Level 1, 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.

About GeneEd's Online Training:

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* This GeneEd Online Training Course is accessible for 90 days via the Internet, and a Certificate of Completion is accessible once requirements are filled.

* GeneEd Online Training Courses have an instructional design which encourages knowledge retention and long term recollection.

* GeneEd Online Training Courses are developed for healthcare professionals (nurses and doctors), clinical researchers, and for patient education.

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Course 1 of 6 units
Price: $175.00 / GBP115.50