What is considered a SUSAR?
What is considered a SUSAR?
All adverse reactions that are suspected to be related to an investigational medicine product that are both serious and unexpected are considered to be SUSAR’s. 4 – Investigational Medicinal Product – IMP. This is an active substance or placebo being tested or used in a medical trial.
What is the difference between an SAE and a SUSAR?
An SAE that occurs during research with a medicinal product is a SAR if there is a certain degree of probability that the SAE is a harmful and undesired reaction to the investigational medicinal product, regardless of the administered dose. If the SAR is unexpected it is called a SUSAR.
What is a SUSAR in clinical trials?
Definition: Any unfavourable occurrence in a trial participant that is judged to have a major impact on their health, was not anticipated and could potentially be due to the intervention under investigation.
What is SUSAR submission?
SUSAR – Suspected Unexpected Serious Adverse Events Reporting.
Who determines a SUSAR?
the Sponsor
Once the Investigator has made the judgement about seriousness and relation to the study drug, the case is communicated to the Sponsor. It is now up to the Sponsor to determine whether the event is a SUSAR and to trigger an expedite reporting process.
Why do we report SUSAR?
The main purpose of the SUSARs is to protect patient safety but also to inform investigators of new developments, ensure compliance with applicable regulations and study integrity.
What makes an SAE a SUSAR?
A Serious Adverse Event (SAE) is any Adverse Event that results in the opinion of the Investigator or Sponsor in: Death or is life-threatening (immediate risk of death) Hospitalization or prolongation of existing hospitalization.
WHO reports a SUSAR?
Fatal or life-threatening serious unexpected suspected adverse reactions (SUSARs) reports: The sponsor (or sponsor-investigator) must notify the FDA of any SUSARs to the study drug as soon as possible but no later than 7 calendar days after the initial receipt of the information.
Who is responsible for SUSAR reporting to investigators?
What is a DSUR?
DSURs are new, internationally-harmonized, safety documents (which became mandatory in European Union member states in September 2011) covering the safety summary of medicinal products during their development or clinical trial phase.
What is the timeline from day of receipt for an initial SUSAR event from a clinical trial to be reported to the FDA with a serious criteria of death?
7 calendar days
Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and must be reported to FDA as soon as possible but no later than 7 calendar days following the sponsor’s initial receipt of the information.
What is DSUR and PSUR?
The Development Safety Update Report (DSUR) is used for drugs still under development to assess risk to the subjects enrolled in the study, while the Periodic Safety Update Report (PSUR) is used for drugs already on the market to assess long-term safety.
