Good Clinical Practice

Good Clinical Practice

by Mindy J. Allport-Settle
     
 

Topics covered include:

* A brief description of the history and development of clinical research and good clinical practice
* Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814
* FDA and ICH GCP Standards for Clinical Research
* Form FDA 1572-Statement of Investigator
* Informed Consent
* Patient

…  See more details below

Overview

Topics covered include:

* A brief description of the history and development of clinical research and good clinical practice
* Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814
* FDA and ICH GCP Standards for Clinical Research
* Form FDA 1572-Statement of Investigator
* Informed Consent
* Patient Recruitment
* State Standards and GCP
* Source Data/Documentation
* Investigator/Site Requirements
* Clinical Monitoring
* Clinical Study Safety Reporting
* Clinical Trial Protocols/Protocol Changes/Protocol Violations
* Institutional Review Boards
* Quality Assurance Activities/Study Auditing/FDA Inspections

• Investigational Drug Accountability, Administration, and Labeling

Product Details

ISBN-13:
9780982147672
Publisher:
PharmaLogika
Publication date:
08/26/2010
Pages:
712
Sales rank:
815,104
Product dimensions:
5.90(w) x 8.90(h) x 1.70(d)
Age Range:
18 Years

Meet the Author

Mindy Allport-Settle has served as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research and development, product commercialization strategies, operational, project and contract management, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology. Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.

Customer Reviews

Average Review:

Write a Review

and post it to your social network

     

Most Helpful Customer Reviews

See all customer reviews >