Exporting related records provides a link between parameter calculations and the data in the original data source that went into the calculation. This is accomplished by creating a RELREC worksheet in the output that stores the connection information.
There are some limitations/considerations when exporting related records:
The original dataset must have a PCSEQ (Sequence Number) column.
The datasource for the PP domain must be an NCA result.
Some of the Final Parameters are calculated based on the points from which the regression line was fitted. For these parameters, the RELREC information should only contain the PC data that was used for Lambda Z calculations.
The CdiscRelRecLZParams.xml configuration file (located in <Phoenix_install_dir>\application\Plugins\CDISC) lists these Lambda Z-based parameters. Parameters specified in this file will have records in the RELREC table that link to a RELID defined as the profile number plus the suffix “LZ”.
Assume that CDISC DM, EX, and PC domains are imported into Phoenix using the CDISC Data Preparer object.
Using the imported CDISC data as input, set up and execute an NCA object.
Map PCSEQ as a Carry column so that it appears in the Summary Table. The PCSEQ column enables referencing the original sequence number in the source data.
The Summary Table and Final Parameters table can be used to determine which entries from original PC dataset were used to calculate the profiles in the NCA analysis.
In the Final Parameters table (stacked), identify the sort key for the parameter of interest.
Go back to the Summary Table and find that sort key. Each associated sequence number that went into this calculation is listed as a separate row with the same sort key.
To export the Final Parameter Results back to CDISC, select File > CDISC > SDTM > Export.
Click in the Datasource cell for one of the domains to export.
Pick datasources for the domains being exported that are either located in the file system or are part of the Phoenix project. For exporting related records, the datasource for the PC domain must be the original dataset.
Note: Selecting the dataset that was imported into the Phoenix project instead of the original dataset is not recommended. During import, modifications to the data have occurred (e.g., different date and time formations, relative time calculations, etc.) and the purpose of exporting related records is to be able to track the data that went into a calculation back to the original CDISC dataset.
Select File System, press OK.
Locate and select the original dataset.
Repeat for each of the domains to export.
For the PP domain, click in the Datasource cell.
The PP domain datasource must be the Final Parameters worksheet from the NCA analysis.
Select Phoenix Project, press OK.
Locate and select the Final Parameters worksheet for the NCA analysis.
When finished mapping the domains to data sources, click the >> button at the bottom of the dialog.
For each domain being exported, adjust the column mappings in the corresponding page as needed and click the >> button.
For the PP domain, turn on the Include RELREC checkbox above the table to create the RELREC.xpt file of related records.
Continue through the Export Wizard and press Finish.
Select the folder in which to export the domains.
The image below shows a portion of an exported RELREC.xpt file. For the rows where IDVAR=PCSEQ, each sequence has an identifier listed in the IDVARVAL column. The RELID column lists the NCA profile identifier. Thus, PCSEQs 11, 13, 17, 19, 23, 25, 30, and 32 were all included in calculating profile P1.
Looking further down in the RELREC.xpt file, where IDVAR=PPSEQ, each row reflects a different parameter. Each sequence number (IDVARVAL) can be tracked back to a parameter that was calculated.
