Adverse event identification and reporting

One of the main objectives of any clinical trial is to assess the efficacy and safety of an intervention compared to a control or other intervention. All trials therefore expose participants to risk, although in many cases, the risks may be no greater than that which they experience in routine clinical practice. To ensure that both expected and unexpected risks are identified during the conduct of a trial it is important to note instances of harm or poor outcomes that occur during the trial. The standard terminology is useful for identification and classification of such events:

Any unfavourable or unintended symptom or sign, including change in laboratory results, temporarily associated with an investigational intervention during the conduct of a clinical trial. It does not matter whether this event is considered related or unrelated to this intervention. These events should be recorded in both the source data (commonly medical notes) and the case report forms (CRF) or adverse event log. The trial protocol should stipulate the necessary requirements for reporting.

AE that has any one of the following features:

  • Results in death
  • Is life threatening (the patient is at risk of death because of the event)
  • Requires hospitalization or prolongation of existing hospitalization.
  • Results in persistent or significant disability/incapacity
  • Results in congenital anomaly or birth defect.

SAE should be reported to the sponsor within 24 hours of the investigator site team knowledge of the event whether verbally or in writing. A full report is to follow with the details and outcome of the event. It should also be recorded and documented as the case with AE.

Where there is a possible causal relationship between the AE and the intervention and this possibility cannot be ruled out.

This terminology relates to trials using a medicinal product (Clinical Trial of an Investigative Medicinal Product [CTIMP] – to learn more about this term, see here). It refers to a serious adverse reaction to investigational medicine where there is a reasonable possibility of the event to be related to the intervention and the nature and severity of this event is not consistent with the information about the product. The term serious satisfies the same criteria specified in the definition of SAE. Reporting of SUSAR should follow the same rules of reporting of SAE with the exception that the sponsor is required in these events to report them to the higher regulatory authorities.

 

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