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ICSR coding

During clinical trials, when reporting specific clinical information like adverse events (AE) and serious adverse events (SAE) or medicinal product names, the reporter may use their own descriptive words and terms, known as verbatim terms, to portray the patient's condition, symptoms, drugs taken, and other relevant details. However, when developing and filling in an Individual Case Safety Report (ICSR), it becomes necessary to code the reported verbatim terms by interpreting them into standardized universal medical terms, so that the ICSR can be properly reviewed and accepted by regulatory bodies.

In PV, you can code these reported verbatim terms directly in the ICSR forms, using the following coding features:

  • MedDRA dictionary coding helps you transform the verbatim terms of the Events, Lab Tests, and other forms containing information on a patient's condition or symptoms.

  • WHODrug dictionary coding helps you transform the verbatim terms of the Products, Parent Drug History, and other forms containing information on investigational products and concomitant medication taken by the patient.

In the following sections, we will guide you through the process of completing the ICSR form and applying coding in one of the two methods—automatically or manually.

In this section:

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any 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.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

An internationally used set of terms relating to medical conditions, medicines, and medical devices created to assist regulators with sharing information.

A coding service that is used for the unified coding of drugs throughout the pharmaceutical industry. In order to achieve this, the service provides the WHODrug dictionary which is an international classification of medicines created by the WHO Program for International Drug Monitoring. The dictionary is managed by the Uppsala Monitoring Centre and contains drug code numbers, along with related information such as trade names, active ingredients, and additional information, such as marketing authorization, pharmaceutical forms, and strengths of the drugs.

For example, the WHODrug drug code for the substance Ibuprofen is 001092 01 001.