Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

Guidance for Industry
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Procedural
October 2009

abrir aquí para acceder al documento FDA:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf