SOP for Handling and reporting of AE and SAE

OBJECTIVE
This SOP gives the procedure for handling and reporting the Adverse Events and Serious Adverse Events encountered during the clinical studies at XXX Hospital.

SCOPE
Applicable to all Clinical studies.

PRECAUTION
Nil

DEFINITION

• Serious Adverse Event: Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
• Serious Adverse Event or Serious Adverse Drug Reaction: An AE or ADR that is associated with death, inpatient hospitalization (in case the study was being conducted on out-patients), prolongation of hospitalization (in case the study was being conducted on in-patients), persistent or significant disability or incapacity, a congenital anomaly or birth defect, or is otherwise life threatening.  
• Adverse Event: An AE is any untoward medical occurrence in a patient or clinical investigation of subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. 

• Unexpected Adverse Event: Any adverse event occurring in one or more subjects such that, the nature, severity or frequency of which is not consistent with either:

1. The known or foreseeable risk of adverse event associated with the procedures involved in the clinical study that are described in (1) the protocol-related documents, such as the IEC approved Study protocol, any applicable investigator brochure, and the current IEC approved informed consent document and (2) other relevant sources of information, such as product labeling and package inserts; or
2. The expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event (if applicable).

ANNEXURE
Nil

REVISION HISTORY
Nil

ALSO READ: SOP for Handling of Biological Samples