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  • whether subject withdrawn due to adverse event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)

  1. Definitions and Reporting Requirements

Category / Definitions / Reporting Requirements
Adverse Events (AE) / 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.
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. / The reporting mechanisms should be outlined in the protocol. In most cases, AEs are collected using specific AE/AR Case Report Forms.
Adverse Reaction (AR) / All untoward and unintended responses to a medicinal product related to any dose administered.
The phrase "responses to a medicinal products" means that a causal relationship between a medicinal product and an AE is at least a reasonable possibility, i.e., the relationship cannot be ruled out. / The reporting mechanisms should be outlined in the protocol. In most cases, ARs are collected using specific AE/AR Case Report Forms. ARs should be followed until resolution or the event is considered stable.
Serious Adverse Events (SAE) / Any adverse event at any dose that:
  • Results in death
  • 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
1The 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
2Medical 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. / All SAEs must be reported to the sponsor immediately (within 1 working day) except those identified in the protocol.
Serious Adverse Reaction (SAR) / An SAE where a causal relationship between a medicinal product and the SAE is at least a reasonable possibility, i.e., the relationship cannot be ruled out. / All SARs must be reported to the MHRA and the relevant ethics committee, with copies to the CTRG in the form of an Annual Safety Report on the anniversary of the Clinical Trials Authorisation (CTA).
Suspected Unexpected Serious Adverse Reaction (SUSAR) / A SAR, the nature or severity of which is not consistent with the applicable product information i.e. Investigator’s Brochure for an unauthorised medicinal product or summary of product characteristics for an authorised product). / 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.
  1. 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 with a cover letter (no standard format)
  1. 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 2009Page 1 of 4

© Copyright: The University of Oxford 2006