SUSAR reporting Sample Clauses
SUSAR reporting. Unexpected adverse reactions are all untoward and unintended responses to an investigational product related to any dose administered These reactions are SUSARs if the following three conditions are met:
1) the event must be serious (see Section 8.2.2 above);
2) there must be a certain degree of probability that the event is a harmful and an undesirable reaction to the medicinal product under investigation, regardless of the administered dose;
3) the event is not listed as an expected serious reaction in the Reference Safety Information (RSI) of the IB.Under 21 CFR 312.32(c), the Sponsor (directly or through a delegated third party) is required to notify FDA and all participating Investigators in an IND safety report (i.e. 7- or 15-day expedited report) of potentially serious risks from clinical trials or any other source as soon as possible, but no later than 7 calendar days for fatal or life-threatening events and 15 calendar days for all other events, after the Sponsor receives the safety information and determines that the information qualifies for reporting. US Investigators are required to promptly report to the Institutional Review Board (IRB) all unanticipated problems involving risk to human subjects or others, including adverse events that should be considered unanticipated problems (21 CFR 312.66), such as IND safety reports. Sobi AG will also report all SUSARs to the EMA's EudraVigilance database within 15 days, as well as to the relevant National Competent Authorities when required. Fatal and life-threatening SUSARs will be reported within 7 calendar days, with another 8 days for completion of the report.
SUSAR reporting. Pfizer will provide Suspected Unexpected Serious Adverse Reactions (“SUSAR”) cases to Institution. Principal Investigator will receive SUSAR reports via the sponsor's SIRIUS system and save them as appropriate keeping in mind that they should be readily available if inspected by either Pfizer or 19.15
SUSAR reporting. Unexpected adverse reactions are all untoward and unintended responses to an investigational product related to any dose administered These reactions are SUSARs if the following two conditions are met:
1) the event must be serious (see section 9.3.2);
2) there must be a certain degree of probability that the event is a harmful and an undesirable reaction to the medicinal product under investigation, regardless of the administered dose; NovImmune will report directly or through delegation to a third party all SUSARs to the investigators and the relevant Ethics Committees, in writing as soon as practical, but at least within 15 days. Fatal and life-threatening suspected SUSARs will be reported within 7 calendar days, with another 8 days for completion of the report. NovImmune will report all SUSARs to the EMA's EudraVigilance database within 15 days, as well as to the relevant National Competent Authorities when required. Fatal and life-threatening suspected SUSARs will be reported within 7 calendar days, with another 8 days for completion of the report.