SAFETY REPORTING REQUIREMENTS IN CLINICAL TRIALS
1. Adverse Event Information
The following information must be collected for all reported adverse events:

participant details

reporter details

adverse event description

start date of event

end date of event

outcome of event

severity of event

relationship to study drug (i.e. causality/relatedness)

action taken with study drug

whether subject withdrawn due to adverse event

whether the event is serious

expectedness (especially important for Serious Adverse Reactions)
Safety Reporting Requirements in Clinical Trials v2.1 dated Sept 2009
© Copyright: The University of Oxford 2006
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2. Definitions and Reporting Requirements
Category
Adverse Events (AE)
Definitions
Reporting Requirements
Any untoward medical occurrence in a patient or clinical
investigation subject administered a medicinal product, which
does not necessarily have to have a causal relationship with this
treatment.
The reporting mechanisms should be outlined
in the protocol. In most cases, AEs are
collected using specific AE/AR Case Report
Forms.
An AE can therefore be any unfavourable and unintended sign
(including an abnormal laboratory finding), symptom or disease
temporally associated with the use of the medicinal product,
whether or not considered related to the medicinal product.
Adverse Reaction (AR)
All untoward and unintended responses to a medicinal product The reporting mechanisms should be outlined
related to any dose administered.
in the protocol. In most cases, ARs are collected
The phrase "responses to a medicinal products" means that a using specific AE/AR Case Report Forms. ARs
causal relationship between a medicinal product and an AE is at should be followed until resolution or the
least a reasonable possibility, i.e., the relationship cannot be event is considered stable.
ruled out.
Serious Adverse Events Any adverse event at any dose that:
All SAEs must be reported to the sponsor
(SAE)
immediately (within 1 working day) except

Results in death
those identified in the protocol.

Is life-threatening1

Requires inpatient hospitalisation or prolongation of
existing hospitalisation

Results in persistent or significant disability/incapacity

Is a congenital anomaly/birth defect

Medically important event2
1
The term "life-threatening" in the definition of "serious" refers to an
event in which the patient was at risk of death at the time of the event; it
does not refer to an event which hypothetically might have caused
death if it were more severe
Safety Reporting Requirements in Clinical Trials v2.1 dated Sept 2009
© Copyright: The University of Oxford 2006
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2
Medical and scientific judgment should be exercised in deciding
whether an adverse event is serious in other situations.
Note: To ensure no confusion or misunderstanding of the difference
between the terms "serious" and "severe", which are not synonymous,
the following note of clarification is provided:
The term "severe" is often used to describe the intensity (severity) of a
specific event (as in mild, moderate, or severe myocardial infarction);
the event itself, however, may be of relatively minor medical
significance (such as severe headache). This is not the same as
"serious," which is based on patient/event outcome or action criteria
usually associated with events that pose a threat to a patient's life or
functioning.
Serious Adverse Reaction An SAE where a causal relationship between a medicinal product All SARs must be reported to the MHRA and
(SAR)
and the SAE is at least a reasonable possibility, i.e., the the relevant ethics committee, with copies to
relationship cannot be ruled out.
the CTRG in the form of an Annual Safety
Report on the anniversary of the Clinical
Trials Authorisation (CTA).
Suspected
Unexpected A SAR, the nature or severity of which is not consistent with the
Serious Adverse Reaction applicable product information i.e. Investigator’s Brochure for an
(SUSAR)
unauthorised medicinal product or summary of product
characteristics for an authorised product).
Safety Reporting Requirements in Clinical Trials v2.1 dated Sept 2009
© Copyright: The University of Oxford 2006
SUSARs which are fatal or life-threatening
must be reported to the MHRA, and to
competent authorities of any state in the European
Economic Area (EEA State) where the trial is
being conducted, and relevant ethics
committees within 7 calendar days of
awareness. Other SUSARs must be reported
within 15 calendar days of awareness.
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3. How to Report a SUSAR?
You can report SUSARs to the MHRA (and other competent authorities, if applicable) and relevant ethics committees by one of the
following methods:
1. Send the completed CIOMS form available at www.cioms.ch/cioms.pdf with a cover letter (no standard format)
2. Send your completed trial-specific or University of Oxford SAE form with a cover letter (no standard format). If you are not using the
university SAE form, please make sure you have all the basic information required (refer to the University form or the CIOMS form).
Safety Reporting Requirements in Clinical Trials v2.1 dated Sept 2009
© Copyright: The University of Oxford 2006
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