Output

When the PC domain is created, the wizard adds the Master PC Worksheet to the Data folder of the Phoenix project. A CDISC folder is also added to the Data folder that contains

PC (PC domain)

CO (CO domain)

SUPPPC (supplemental PC domain)

ADPC (validation report, SDTM standard only with ADaM data imported)

ADSL (ADSL domain, SDTM standard only with ADaM ADSL data imported)

DM (DM domain, SDTM standard only with ADaM DM data imported)

The following NCA worksheets are also added to the Data folder.

NCA_PLASMA_Worksheet: Excludes all samples when the PCEXCLFL=”Y” and all records where the matrix (PCSPEC) belongs to the model type: URINE (210 –212).

NCA_URINE_Worksheet: Excludes all samples when the PCEXCLFL=”Y” and all records where the matrix (PCSPEC) belongs to the model type: PLASMA (200 –202). The StartTime column is added and populated using the formula: StartTime = PCTPT – PCEVLINT.

NCA_DOSING_Worksheet

NCA_SORT_KEYS (list of sorting columns in the PC domain and corresponding column names in the dosing data)

The following are added to the Documents folder:

Study Configuration (list of all setting values for the study)

Validation Report (list of any issues identified during the domain creation process.

An NCA object for plasma and/or for urine are added to the workflow.