|
|
 |
|
|
 |
 |
|
|
|
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 |
 |
Phases of Research |
|
Terminology |
|
Roles and Responsibilities of the Clinical Research Team |
| FDA GCP & ICH GCP - The Investigator's Perspective |
|
ICH GCP (E6) Section 4: Investigator |
|
FDA GCP: Investigator Obligations 21 CFR312 |
|
FDA Form 1572 "Statement of the Investigator" |
|
Electronic Records and Signatures |
|
Financial Disclosure |
|
Protection of Human Subjects |
| Clinical Trial Fundamentals |
|
FDA Form 1572 and Protocol/Protocol Amendments and Investigator Brochure |
|
Investigational Medicinal Product Storage, Documentation, and Problem Solving |
|
Consenting Subjects |
|
Source Documentation Strategies |
|
Case Report Form and Data Clarification Records |
|
HIPAA compliant Subject Recruitment and Retention |
|
Interactions with the Monitor |
|
Budget Issues and tracking payments |
|
SAEs and Non-SAEs Recognizing and Reporting |
|
|
 |
|
|
|
|
|
| © 2008 Mithas Labs. All rights reserved. |
| |
|
