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Note: The answers to the questions will not appear until you have answered the previous question. Reset to change your responses.
Seriousness
Is the event serious?
Seriousness
Is the event serious?
Causality
Is the event related to the IMP?
Causality
Is the event related to the study procedures?
Expectedness
Is the event unexpected?
Expectedness
Is the event unexpected?
Event Type and Reporting Requirements
Event is a: SUSAR (Suspected Unexpected Serious Adverse Reaction)
Report to Sponsor (within 24 hours of becoming aware) using Study SAE form
Sponsor (or person delegated responsible for Pharmacovigilance) to report to Competent Authority and main REC within 7 calendar days of first notification to sponsor for fatal /life threatening SUSARS, and within 15 calendar days of first notification to sponsor for all other SUSARs
SUSARs should be reported in the DSUR and in the end of study summary clinical trial report
Event is a: SAR (Serious Adverse Reaction)
Report to Sponsor (within 24 hours of becoming aware) using Study SAE form unless protocol identifies the event as not requiring reporting.
SARs should be reported in the DSUR and reported in the end of study summary clinical trial report
Event is an: SAE (Serious Adverse Event)
Report to Sponsor (within 24 hours of becoming aware) using Study SAE form unless protocol identifies the event as not requiring reporting
SAEs should be reported in the DSUR and in the end of study summary clinical trial report
Event is an: AR (Adverse Reaction)
Record on Study AE CRF (medical records and AE logs as appropriate)
ARs should be reported in the end of study summary clinical trial report
Event is an: AE (Adverse Event)
Record on Study AE CRF (medical records and AE logs as appropriate).
Ongoing review of AE trends by Chief Investigator (or TSC/IDMC as appropriate)
Event is a: SAE (Related & Unexpected Serious Adverse Event)
Report to Sponsor (within 24 hours of becoming aware) using Study SAE form.
Chief Investigator to report to main REC within 15 days of becoming aware using NRES template (copy to Sponsor)
Chief Investigator to report in annual progress report to main REC (and copy to sponsor)
Event is a: SAR
Report to Sponsor (within 24 hours of becoming aware) using Study SAE form in line with Sponsor SOP ?? unless protocol identifies the event as not requiring reporting.
SARs should be reported in the DSUR in line with Sponsor SOP ?? and reported in the end of study summary clinical report in line with Sponsor SOP ??
Event is an: SAE (Serious Adverse Event)
Report to Sponsor (within 24 hours of becoming aware) using Study SAE form unless protocol identifies the event as not requiring reporting as an SAE.
Event is an: AE
Record on Study AE CRF (medical records and AE logs as appropriate).
Ongoing review of AE trends by Chief Investigator (or TSC/IDMC as appropriate)
Event is not an : Adverse Event
Consider whether a research related incident should be reported.