Basics - Part 11 - Serious Adverse Event

[@tanveerahmedkhan8462]

Who can report an adverse event (AE)? A. Participant B. Participant's spouse C. Caregiver D. Participant's family member E. Research Nurse F. All of the above can report an AE

[@GCPMindset]

It is the responsibility of all parties involved in the clinical trial to report any adverse events (AEs) that occur during the course of the trial in clinical research. The clinical trial sponsor is ultimately responsible for ensuring that all AEs are promptly reported to regulatory authorities in accordance with the regulatory bodies' guidelines. AEs can, however, be reported to the sponsor or regulatory authorities by healthcare professionals, study investigators, clinical research associates, and patients themselves. In summary, while the sponsor is ultimately responsible for reporting AEs, it is the responsibility of all parties involved in the clinical trial to report any AEs as soon as possible to ensure patient safety and aid in the evaluation of the efficacy and safety of the drug or medical device being tested.

[@MultiDance9]

😃 Amazing channel keep bringing these type of interesting illustrations related to CT, we need this channel to understand better

[@GCPMindset]

Thank you very much for your feedback!

[@Ferienpapst]

great, i learn a lot here

[@GCPMindset]

Glad it was helpful!

[@Ferienpapst]

@@GCPMindset in currently applying for a job as a remote site monitor:) might have an interview tomorrow and I did really learned here good Informations

[@fredrikh9299]

Thank you!