Abstract
This chapter provides an overview of safety assessment in clinical trials, including challenges for designing and reporting studies measuring safety. Adverse events are undesirable, unfavorable, harmful, and unexpected effects resulting from a normal dosage of drug, medication, therapy, or any other intervention such as surgery. Monitoring of adverse events is critical to the patient’s safety (i.e., human subject’s protection) and data integrity in clinical trials. Moreover, this chapter reviews the regulatory aspects related to adverse events in clinical trials. Finally it presents a case discussion in which an unexpected adverse effect is detected and investigators need to determine whether this event is or is not related to the intervention and define a plan of action.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
