Sponsor procedure describing how to code adverse events using the Medical Dictionary for Regulatory Activities (MedDRA).

This procedure explains the strategy to code adverse event using the MedDRA dictionary. It is important to consider how you are going to harmonise adverse event terms in your study so you can report meaningful results (e.g., liver enz increase, liver enzyme increased, elevated liver enzyme = these are all the same term spelled out slightly differently). We chose the MedDRA dictionary as it is an international standard recognized globally by most regulators and Ethics Committees. You can also use other dictionnaries such as ICD-10 or your own library (could be built in your database as a drop down menu). It is recommended to have a procedure to explain how the coding is done and this procedure can be used as a template.

Taregt user: Sponsor (can be adapted to be done by the site)