The protocol requires PK and safety data for the DE decision; therefore we expect QC on that data. Monitoring covers transcription of data into the CRF, so this is covered for critical parameters. However Dose Escalation reports are usually written quickly (and outside the normal data management process), with tables transcribed directly from the source documents, therefore we expect QC at this step if this data is transcribed again. This would not be covered by monitoring if the report was prepared directly from the medical notes. If the data used to prepare the dose escalation report used specific programmes to generate listings, then this would need programming validation/QC checks also.
However it is acceptable to use a risk based process, but this would need to be clearly documented in a formal procedure and the risk assessment.