An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period.

Saxena, U; Bose, D; Saha, S; Gogtay, NJ; Thatte, UM.

Indian J Med Ethics ; 2022 Jun; 7(2): 108-113

Article | IMSEAR | ID: sea-222655

Key words

Investigational plan; informed consent; monitoring; documentation

Full text: 1 Index: IMSEAR Journal: Indian J Med Ethics Journal subject: Ethics Year: 2022 Type: Article

Full text: 1 Index: IMSEAR Journal: Indian J Med Ethics Journal subject: Ethics Year: 2022 Type: Article