| |
|
|  |
|
|
- Belmont Report
The Belmont Report is the “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”. Finalized on April 18, 1979 by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, this document identifies 3 primary ethical principles: Respect for Persons, Beneficence, and Justice.
- FDA Commissioner speech
Speech to Pharmaceutical Research Manufacturers ofAmerica by Mark B. McClellan, M.D., Ph.D. Commissioner, Food and Drug Administration given on March 28, 2003 regarding drug development.
- Monitoring
FDA Bioresearch Guidelines for the Monitoring of Investigators
|
|
|
|
|
|
|
|
print