My questions is regarding how to interpret the MHRA recommendation (Grey guide section 12.6.2) that there should be a clear quality control (QC) process to confirm that the data collated into the dose escalation interim report are accurate to ensure a decision is based in robust data. Does a ‘clear QC process’ mean 100% source data verification (SDV) of all data (i.e. both critical and non-critical data) to be used for the dose escalation decision?

In our Phase I oncology trials, the documented QC process is detailed in the study-specific monitoring guidelines. All source data in the patient medical records is source data reviewed (SDR) by the Clinical Research Associate (as per the Transcelerate definition of SDR).