Adverse Event
Clinical trial, Institutional review board, Food and Drug Administration
Herausgegeben: Humphrey, Lóegaire
Versandkostenfrei!
Versandfertig in 6-10 Tagen
26,99 €
inkl. MwSt.
PAYBACK Punkte
13 °P sammeln!
Please note that the content of this book primarily consists of articles available from Wikipedia or other free sources online. An adverse event (AE) is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment (study medication, application of the study device, etc.) or within a previously specified period of time after the treatment has been completed.AEs in patients participating in clinical trials must be reported to the local institutional review board (IRB) and the study sponsor. Adverse events ca...
Please note that the content of this book primarily consists of articles available from Wikipedia or other free sources online. An adverse event (AE) is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment (study medication, application of the study device, etc.) or within a previously specified period of time after the treatment has been completed.AEs in patients participating in clinical trials must be reported to the local institutional review board (IRB) and the study sponsor. Adverse events categorized as "serious" (for example death, illness requiring hospitalization, events deemed life-threatening, or involving cancer or fetal exposure) must be reported to the regulatory authorities immediately, whereas minor adverse events are merely documented in the annual summary sent to the regulatory authority.
