VICT3R Standard Operating Procedure (SOP) for Virtual Control Groups
The VICT3R “Standard Operating Procedure for the Implementation of Virtual Control Groups in Preclinical Studies”, provides the practical framework for generating and applying Virtual Control Groups (VCGs) in repeated-dose toxicity studies.
The SOP defines study-specific criteria for filtering relevant animals from historical control data while accounting for potential confounding factors, followed by matching criteria to generate a VCG representative of the animals in the treatment groups. It also provides guidance for the transparent reporting of VCG selection and study data evaluation and is designed to be applicable across study facilities.
Version 1 of the SOP was submitted to the European Medicines Agency (EMA) as part of the qualification procedure for VCGs. It was made publicly available on 31 March 2026, alongside the EMA Draft Qualification Opinion on the use of Virtual Control Groups (VCGs) to replace Concurrent Control Groups (CCGs) in rat non-GLP Dose-Range Finding (DRF) studies.
The SOP is a living document that is continuously revised as experience within VICT3R progresses, incorporating new knowledge and practical learnings from the regulatory qualification process. Feedback on the SOP is always welcome.
Updated versions will be published on this page.
