CASE PROCESSING

ICSR is a report that contains information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient is termed an individual case safety report. Safe use of medicines continues to be a crucial issue globally and is the prime responsibility of stakeholders of the health system. Besides the patient identification data, it should also specify time frames of the adverse reactions, details of medications used, dechallenge, and rechallenge details to mention a few. These ICSRs need to be submitted within rigid time frames as specified by the regulatory authorities.