SeerPharma Pty Ltd :: DISCover web-based training :: GCP 2: Good Clinical Practice, Level 2

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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.

COURSE 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

COURSE OBJECTIVES

Students completing this course 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

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