Up until the 20th century, there were few federal laws regulating the contents and sale..
According to the World Health Organization, “Pharmacovigilance (PV) is defined as the science and activities..
Participating in a clinical trial: The diversity observed in society, by consensus, should be reflected..
Safety data are reported and examined at various stages of an investigation and by different..
Recording and storing data in a controlled, consistent and reproducible manner for data retrieval and..
All U.S. clinical trials must include mechanisms to ensure the ethical treatment of human subjects…
Given the specific IND safety reporting requirements for the sponsor, drug safety operations and management..
Closing or locking a study database is fundamental to preventing inadvertent or unauthorized changes once..
Annual Reports Requirements for Safety are listed in the 21CFR Part 312.33(b). This list includes summary information..
Investigational products are sometimes used for treatment of serious or life-threatening conditions either for a..