We are currently trying to establish what (if any) oversight is expected for laboratories that conduct analysis of exploratory/ research endpoints within clinical trials. Whilst the MHRA blog on oversight recommends a risk-adapted approach (with exploratory labs used as an example for adapted oversight), and the EMA reflection paper on clinical labs excludes exploratory analysis from scope (which we presume is a risk commensurate exclusion of requirements), there is no specific guidance on expectations of the regulators around what is considered a suitable degree of oversight of these "lower risk" labs by Sponsors. Any insights/ guidance would be appreciated.