Abstract

SAE in research situations do happen and will happen in subjects taking investigational products.

SAE reporting presently is mandatory by law since Jan 2013. 

CDSCO is continuously monitoring the trials and SAE’S with the objective of Patient safety when in trials and enforcing Ethical conduct of trials so that Data obtained from reports finally helps in safe use of medicines.

Reporting of SAE’s has to follow timelines.

Submission of SAEs should be supported with complete and correct documents thereby enabling the regulatory authorities to arrive at a causality assessment which is crucial for risk benefit assessment.

In case of death/injury occurring in the trial subjects, their nominees would be entitled to financial compensation. This amount will be over and above any expenses incurred due to medical management of the subject. Hence causality determination a vital part of reporting any SAE’s.