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 the following SEND and SDTM Controlled Terminology code lists. If a different terminology set is imported, it will be stored in the SQLite database.
|
Code |
Codelist Code |
Codelist Name (CDISC Submission Value |
|
C77529 |
C77529 |
Specimen (SPEC) |
|
C85839 |
C85839 |
PK Parameters Code (PKPARMCD) |
|
C85494 |
C85494 |
PK Units of Measure (PKUNIT) |
|
C66789 |
C66789 |
Not Done (ND) |
|
C66742 |
C66742 |
No Yes Response (NY) |
|
C78737 |
C78737 |
Relationship Type (RELTYPE) |
|
Code |
Codelist Code |
Codelist Name (CDISC Submission Value |
|
C78734 |
C78734 |
Specimen Type (SPECTYPE) |
|
C85839 |
C85839 |
PK Parameters Code (PKPARMCD) |
|
C85494 |
C85494 |
PK Units of Measure (PKUNIT) |
|
C66789 |
C66789 |
Not Done (ND) |
|
C66742 |
C66742 |
No Yes Response (NY) |
|
C78733 |
C78733 |
Specimen Condition (SPECCOND) |
|
C85492 |
C85492 |
Method (METHOD) |
|
C78737 |
C78737 |
Relationship Type (RELTYPE) |
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.
SEND 3.0
|
Constructed Variable |
Description |
|
--SEQ |
Sequential number identifying records within a dataset. |
|
--STRESC |
Copy of --ORRES. |
|
--STRESN |
When --STREC contains a numeric result, the numeric equivalent is reported in --STRESN. |
|
--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
|
Constructed Variable |
Description |
|
--SEQ |
Sequential number identifying records within a dataset. |
|
--STRESC |
Copy of --ORRES. |
|
--STRESN |
When --STREC contains a numeric result, the numeric equivalent is reported in --STRESN. |
|
--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
|
|
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
|
Constructed Variable |
Description |
|
--SEQ |
Sequential number identifying records within a dataset. |
|
--STRESC |
Copy of --ORRES. |
|
--STRESN |
When --STREC contains a numeric result, the numeric equivalent is reported in --STRESN. |
|
--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
|
|
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. |
