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Best Practices in Biopharma Manufacturing Best Practices in Clinical Research Biotechnology & Genetics Major Therapeutic Areas Pharmaceutical and Healthcare Codes of Conduct
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Anatomy and Physiology Bioinformatics BioPharma Cardiovascular System Central Nervous System (Neurology) Diabetes Gastrointestinal System Good Clinical Practice (GCP) Good Laboratory Practice (GLP) Good Manufacturing Practice (GMP) Immunology Infection IS/IT Series Marketing & Selling Medical Devices Musculoskeletal System Oncology Ophthalmology Pain Psychiatric Disorders Quality Control (QC) Respiratory System Urology Validation
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| | GCP 2: Good Clinical Practice, Level 2 Duration: 2 Hours and 30 Minutes
Certificate of Completion:
Provided immediately upon successful completion. |
Ordering For Multiple Users (training 10 - 200 users, annually) see GeneEd's On Demand Training |
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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.
Similar or Related Courses & Suites:
SUITE: Good Clinical Practice: Two Course Suite
 GCP 1: Good Clinical Practice, Level 1
GCP 2: Good Clinical Practice, Level 2
SUITE: Drug Development Pipeline: Essential Regulations (Seven Course Suite)
GLP 0: Good Laboratory Practice, Overview
21 CFR Part 11
GMP 0: Good Manufacturing Practice, Overview
GCP 1: Good Clinical Practice, Level 1
GCP 2: Good Clinical Practice, Level 2
Drug Safety: Adverse Event Reporting
GXP: Industry Overview
About GeneEd's Online Training:
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and a Certificate of Completion is accessible once requirements are filled.
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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
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
| | GCP 2: Good Clinical Practice, Level 2
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. |
BROWSE COURSES BY CATALOG:
| Best Practices in Biopharma Manufacturing | Best Practices in Clinical Research | Biotechnology & Genetics | Major Therapeutic Areas | Pharmaceutical and Healthcare Codes of Conduct |
BROWSE OTHER COURSES BY DISCIPLINE:
| Anatomy and Physiology | Bioinformatics | BioPharma | Cardiovascular System | Central Nervous System (Neurology) | Diabetes | Gastrointestinal System | Good Clinical Practice (GCP) | Good Laboratory Practice (GLP) | Good Manufacturing Practice (GMP) | Immunology | Infection | IS/IT Series | Marketing & Selling | Medical Devices | Musculoskeletal System | Oncology | Ophthalmology | Pain | Psychiatric Disorders | Quality Control (QC) | Respiratory System | Urology | Validation |
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