Internal pharmacovigilance unit procedure detailing the data entry conventions in the safety (pharmacovigilance) database administration.

If you use a safety/pharmacovigilance database, it is recommended to ensure data consistency to detail in a procedure how the data are entered in the database (which data go in which database fields and rules on how to capture). This simple procedure can be used as a template but please note the non-ICH database fields can be different. It is important to also verify your current ICH guidelines to make sure not outdated information is copied from this SOP.

Target user: Sponsor pharmacovigilance officer