ABSTRACT
This chapter provides examples of protocol compliance checks. There are many protocol amendments that need confirmation and adjustments based on more exploratory analysis. Protocol compliance checks include missing USUBID, invalid lab baseline values and discrepancies in exposure and/or daily dose data. In some cases, USUBJID is missing in DM or ADSL but exists in other SDTMs or ADaMs. For patients randomized to treatment dose, it is important to monitor corresponding exposure records to assure protocol compliance administration requirements. The baseline measure is often identified as the last lab measurement before dose administration. In general, baseline flags are derived in ADaMs in a BDS structure. A separate check is performed to minimize the number of missing baseline results.
