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Course Description
This course is designed to provide a brief overview of clinical research with a comprehensive review of FDA GCP and ICH GCP (E6) and the fundamental elements involved in coordinating a clinical trial. It provides practical tips and suggestions that can be applied to promote a GCP and HIPAA compliant clinical trial, including preventative measures and problem solving techniques of some of the most common GCP non-compliance issues.
1 |
Discuss the drug/biologic development process |
2 |
Define GCP and identify its application in clinical research |
3 |
List the key components of a clinical trial |
4 |
Determine the GCP requirements for the informed consent, adverse and serious adverse events, source documentation and study drug accountability |
Daily Agenda / Course Topics
Overview of Clinical Research |
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Phases of Research |
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Terminology |
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Roles and Responsibilities of the Clinical Research Team |
FDA GCP & ICH GCP - The Investigator's Perspective |
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ICH GCP (E6) Section 4: Investigator |
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FDA GCP: Investigator Obligations 21 CFR312 |
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FDA Form 1572 "Statement of the Investigator" |
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Electronic Records and Signatures |
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Financial Disclosure |
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Protection of Human Subjects |
Clinical Trial Fundamentals |
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FDA Form 1572 and Protocol/Protocol Amendments and Investigator Brochure |
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Investigational Medicinal Product Storage, Documentation, and Problem Solving |
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Consenting Subjects |
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Source Documentation Strategies |
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Case Report Form and Data Clarification Records |
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HIPAA compliant Subject Recruitment and Retention |
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Interactions with the Monitor |
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Budget Issues and tracking payments |
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SAEs and Non-SAEs Recognizing and Reporting |
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© 2008 Mithas Labs. All rights reserved. |
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