Safety Reporting Flowchart – UK Example All adverse events must be recorded from the moment the research
participant has signed the informed consent form
Adverse Event
An ‘Adverse Event’ is defined as:
·∙ Any untoward medical occurrence in a clinical research
subject which may or may not be related to the IMP (CTIMP)
or research product or procedure (Non-CTIMP)
Was the event serious?
·∙ ·∙ ·∙ ·∙ Did it result in death?
Was it life threatening?
Did it require hospitalisation or prolongation of hospitalisation?
Did it result in a persistent or significant disability or
incapacity?
Did it result in a congenital anomaly or birth defect?
·∙ Serious?
NO
ADVERSE EVENT (AE)
·∙ Record Adverse Event (AE) in the CRF
and Patient case notes
·∙ Follow-up AE until resolved
NO
SERIOUS ADVERSE EVENT (SAE)
·∙ Complete the SAE Report Form
·∙ Fax or email the completed form to the
Sponsor within 24 hours of the event
·∙ Follow up the SAE Report
·∙ Record SAE in the CRF and Patient case
notes
·∙ Follow-up SAE until resolved
YES
SERIOUS ADVERSE REACTION (SAR)
·∙ Complete the SAE Report Form
·∙ Fax or email the completed form to the
Sponsor immediately or within 24 hours of
the event
·∙ Follow up the SAE Report
·∙ Record SAR in the CRF and Patient case
notes
·∙ Follow-up SAR until resolved
YES
Is the Event Related to the IMP/Procedure?
·∙ ·∙ Is the SAE likely to be related to the IMP/Procedure?
Is the event judged by the Investigator to have a reasonable
causal relationship to an IMP/Procedure i.e., does the SAE
have a causal relationship that is ‘definitely, ‘probably’ or
possibly’ related to administration of an IMP?
Related?
Was the Serious Adverse Reaction Expected?
·∙ ·∙ All expected ARS and SARs will be listed in the product
information (i.e., the protocol, Investigators Brochure
(unlicensed medicinal products), Summary of Product
Characteristics (licensed medicinal products))
Reactions are considered ‘unexpected’ if they dds significant
information on the specificity or severity of an expected
adverse reaction.
Expected?
NO
CTIMP
SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION
(SUSAR)
The Study Sponsor must:
·∙ Review all SAE Report Forms within 24 hours of receipt
·∙ Ensure all necessary information is provided by the
Investigator and seek further information, as necessary
·∙ Notify Chief Investigator as soon as possible
·∙ Submit the SUSAR report to the MHRA using the eSUSAR
system within 7 days (if fatal or life threatening) or within 15
days (for all other SUSARs)
·∙ Review the Risk/Benefit profile for the study
Chief Investigator must:
·∙ Submit a copy of the SUSAR report to the REC that gave the
favourable opinion for the study within 7 days (if fatal or life
threatening) or within 15 days (for all other SUSARs)
·∙ Notify all Principal Investigators on the Study
NO
Non-CTIMP
SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION
(SUSAR)
The Study Sponsor must:
·∙ Review all SAE Report Forms within 24 hours of receipt
·∙ Ensure all necessary information is provided by the
Investigator and seek further information, as necessary
·∙ Notify Chief Investigator as soon as possible
Chief Investigator must:
·∙ Complete the NRES SAE Report Form and submit to the
REC that gave the favourable opinion for the study within 15
days of the SUSAR occurring
·∙ Notify all Principal Investigators on the Study
Principal Investigators should:
·∙ Notify their Trust R&D Department (as per local policy)
Principal Investigators should:
·∙ Notify their Trust R&D Department (as per local policy)
1st December 2011 www.chcuk.co.uk