PK Submit Preferences

Preferences

PK Submit preferences, available to the user via the Preferences dialog (Edit > Preferences), consist of a General Configuration screen to allow the uploading of CDISC SEND- and SDTM-controlled terminology.

In the Preferences dialog, select PK Submit > General Configuration.

Choose the Import SEND Terminology or Import SDTM Terminology button.

In the file browser, navigate to and select the file containing the terminology settings. The file must be in Excel XLS format (*.xls).

The PK Submit SQLite database distributed with Phoenix is preloaded with SEND and SDTM Controlled Terminology code lists. If a different terminology set is imported, it will be stored in the SQLite database.

The SEND/Codelist code and Codelist name are listed below (the CDISC Submission Value is in parentheses):

C77529 Specimen (SPEC)
C85839 PK Parameters Code (PKPARMCD)
C85494 PK Units of Measure (PKUNIT)
C66789 Not Done (ND)
C66742 No Yes Response (NY)
C78737 Relationship Type (RELTYPE)

The SDTM/Codelist code and Codelist name are listed below (the CDISC Submission Value is in parentheses):

C78734 Specimen Type (SPECTYPE)
C85839 PK Parameters Code (PKPARMCD)
C85494 PK Units of Measure (PKUNIT)
C66789 Not Done (ND)
C66742 No Yes Response (NY)
C78733 Specimen Condition (SPECCOND)
C85492 Method (METHOD)
C78737 Relationship Type (RELTYPE)

CDISC time formats

Below are some important notes regarding the time formats used in CDISC.

All the date, time, and collection time fields are in ISO 8601 format as defined by the CDISC standards.
The format of CDISC data after import may differ depending upon the default local/regional ISO format for the environment in which Phoenix is running. The mm/dd/yyyy ISO date format may not be the default and may not even be an option in some regions.

Constructed variables

SEND 3.0

--SEQ: Sequential number identifying records within a dataset.
--STRESC: Copy of --ORRES.
--STRESN: Reports the numeric equivalent when --STREC contains a numeric result.
--STRESU: When --STRESC contains a numeric result, --ORRESU is reported in --STRESU.
--SPEC: Derived from the specimen name used during sample collection.
USUBJID: Concatenation of STUDYID-SUBJID.
PCTESTCD: “ANALYTE” + sequence number (0-9)
PCTPT: PCTPTNUM + Time Unit

PCTPTREF: “Time unit” + VISITDY + “Dose”

POOLID: A concatenation of all NCA sort key, separate each key with a dash “-”.
--GRPID: A concatenation of all NCA sort key, separate each key with a dash “-”.
PPCAT: Copy of PCTEST.
PPSCAT: “NON-COMPARTMENTAL” hardcode.
PPSTINT: Start time found in the partial area in the ISO format.
PPENINT: End time found in the partial area in the ISO format.
PPTPTREF: Copy of PCTPTREF.

SEND 3.1

PCTPT: PCTPTNUM + Time Unit

PCNOMLBL: “Time unit” + PCNOMDY

PCTPTREF: PCNOMLBL + “Dose”.
POOLID: A concatenation of all NCA sort key, separate each key with a dash “-”.
--GRPID: A concatenation of all NCA sort key, separate each key with a dash “-”.
PPCAT: Copy of PCTEST.
PPSCAT: “NON-COMPARTMENTAL” hardcode.
PPSTINT: Start time found in the partial area in the ISO format.
PPENINT: End time found in the partial area in the ISO format.
PPTPTREF: Copy of PCTPTREF.
PPNOMDY: Copy of PCNOMDY.
PPNOMLBL: Copy of PCNOMLBL.

SDTM

VISIT: “Time unit” + VISITDY

PCTPTREF: VISIT + “Dose”.
--GRPID: A concatenation of all NCA sort key, separate each key with a dash “-”.
PPCAT: Copy of PCTEST.
PPSCAT: “NON-COMPARTMENTAL” hardcode.
PPSTINT: Start time found in the partial area in the ISO format.
PPENINT: End time found in the partial area in the ISO format.