Serious Adverse Events

A cover letter from the Principal Investigator must accompany the supporting documents. In addition to the electronic submission of all the documents and cover letter, one hard copy of theses documents should be submitted.

MCC guidelines for reporting SAE

It is the Principal Investigator’s duty to summarize and interpret all documents that need to be evaluated by the Ethics Committee such as the reporting of Serious Adverse Events. Relevance and causality need to be placed in prospective even if the SAE occurred elsewhere.

MCC definition of a SAE

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 (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

Kindly note that Principal Investigator is requested to please submit a "hard paper copy format"  of the above documents. 

Where to submit electronically and physically?