GCP 2: Good Clinical Practice, Level 2

Duration: 2 Hours and 30 Minutes

Certificate of Completion:

Provided immediately upon successful completion.

GCP 2: Good Clinical Practice, Level 2 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 the standards used in clinical studies from start-up to post-study audits.

Accreditation: GeneEd designates this educational activity for a maximum of 2.50 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 2: Good Clinical Practice, Level 2

OUTLINEINTRODUCTION

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: Students completing this course, GCP 2: Good Clinical Practice, Level 2, should be able to:

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.

About GeneEd's Online Training:

* GeneEd Online Training Courses are high-quality, Flash driven, learning tools including voiceovers and dynamically engaging graphic animations.

* 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.

* To access your GeneEd Online Training Course, your username, password and login URL will be provided to you shortly after ordering.

Course 2 of 6 units
Price: $275.00 / GBP181.50