Pharmacovigilance in Clinical Trials Flashcards
Which 2 agencies carry out authorisation for medicines before they are marketed and made available to patients?
EMA
MHRA
What does RSI stand for?
Referent Safety Information
Where is the RSI normally found?
Found in the investigator’s brochure.
What is the purpose of an RSI?
Informs investigator of the ‘expectedness’ of an adverse event.
Why is an RSI important in regards to a SUSAR?
Helps the investigator to decide whether a serious adverse can be reported as a SUSAR.
What is the sponsors stance on pharmacovigilance?
Maintains an overall purpose built pharmacovigilance database to log and analyse these events.
What is a DSUR?
A common standard for annual reporting for clinical trials which contain safety data.
Who is the DSUR submitted to?
MHRA
Ethics Committee
