Safety reporting flowchart
AE Observed
Is it serious?
An event is considered
serious if it meets one or
more of the following criteria:
 results in death
NO
YES
is life-threatening
requires hospitalisation or prolongation of existing hospitalisation
AE
Record on Case Report
Forms/Medical Notes
Is the event included in the
Study Protocol, Investigator’s
Brochure or SmPC?
results in persistent or significant disability or
incapacity
consisits of a congenital anomaly or birth defect
Other health event which in the opinion of the clinician is serious
YES
NO
SAE
Record, Assess and Report to
Sponsor & CI within 24 hours*
or as agreed with Sponsor
Is it possibly, probably or
definitely related to the
study intervention
or trial medication?
NO
YES
SAE
Record, Assess and Report to
Sponsor & CI within 24 hours*
or as agreed with Sponsor
SAR
Key
Is the SAR expected?
YES
NO
SAR
Record, Assess and
Report to Sponsor & CI
within 24 hours*
SUSAR
Record, Assess and
Report to Sponsor & CI
within 24 hours*
AE Adverse Events
SAE Serious Adverse Events
AR
Adverse Drug Reaction
SAR Serious Adverse drug Reaction
SUSAR Suspected Unexpected Serious Adverse
Reaction
* A follow-up report should be
submitted in writing within 48
hours
** Follow-up information to be
provided in further 8 days
Is it fatal or life threatening?
YES
NO
Report to
R&I/MHRA/REC
within 7 days**
Report to
R&I/MHRA/REC
within 15 days
R&I/Mar2011