Internal pharmacovigilance unit procedure detailing how compliance with pharmacovigilance processes is monitored and documented.

If you don't use a pharmacovigilance unit/department at Sponsor level, you can use the same process as in SM-005-CT. If you have a pharmacovigilance unit, you will need a dedicated compliance process that can be the same as we used in this SOP or similar to the study deviation process.

Target user: Sponsor pharmacovigilance officer