SEND PP specification

STUDYID

Study Identifier

Char

Identifier

Unique identifier for a study.

Req

DOMAIN

Domain Abbreviation

Char

PP

Identifier

Two-character abbreviation for the domain.

Req

USUBJID

Unique Subject Identifier

Char

Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated.

Exp

POOLID

Pool Identifier

Char

Identifier

Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated.

Perm

PPSEQ

Sequence Number

Num

Identifier

The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.

Req

PPGRPID

Group Identifier

Char

Identifier

Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number.

Perm

PPTESTCD

Parameter Short Name

Char

(PKPARMCD)

Topic

Short name of the measurement, test, or examination described in PPTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PPTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PPTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: AUCINT, TMAX, CMAX.

Req

PPTEST

Parameter Name

Char

(PKPARM)

Synonym Qualifier

Long name for PPTESTCD. The value in PPTEST cannot be longer than 40 characters. Examples: AUC from T1 to T2, Time of CMAX, Max Conc.

Req

PPCAT

Parameter Category

Char

Grouping Qualifier

Used to define a category of parameters associated with a specific analyte. This must be the analyte in PCTEST whose profile the parameter is associated with.

Exp

PPSCAT

Parameter Subcategory

Char

Grouping Qualifier

Categorization of the model type used to calculate the pharmacokinetic parameters. Examples include COMPARTMENTAL, NON-COMPARTMENTAL.

Perm

PPORRES

Result or Findings as Collected

Char

Result Qualifier

Result of the measurement or finding as calculated.

Exp

PPORRESU

Unit of the Original Result

Char

(PKUNIT)

Variable Qualifier

The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the CDISC Controlled Terminology list.

Exp

PPSTRESC

Standardized Result in Character Format

Char

Result Qualifier

Contains the result value for all findings, copied or derived from PPORRES in a standard format or standard units. PPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PPSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in PPORRES and these results effectively have the same meaning, they could be represented in standard format in PPSTRESC as NEGATIVE. For other examples, see general assumptions.

Exp

PPSTRESN

Standardized Result in Numeric Format

Num

Result Qualifier

Used for numeric results or findings in standard format; contains the numeric form of PPSTRESC. PPSTRESN should store all numeric test results or findings.

Exp

PPSTRESU

Unit of the Standardized Result

Char

(PKUNIT)

Variable Qualifier

Standardized unit used for PPSTRESC and PPSTRESN.

Exp

PPSTAT

Completion Status

Char

(ND)

Record Qualifier

Used to indicate that a parameter was not calculated. Should be null if a result exists in PPORRES.

Perm

PPREASND

Reason Not Done

Char

Record Qualifier

Describes why a parameter was not performed, such as INSUFFICIENT DATA. Used in conjunction with PPSTAT when value is NOT DONE.

Perm

PPSPEC

Specimen Material Type

Char

(SPEC)

Record Qualifier

Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE.

If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine clearance), refer to TIG guidance on how to populate.

Exp

VISITDY

Planned Study Day of Collection

Num

Timing

Planned study day of collection. Should be an integer.

Perm

PPNOMDY

Nominal Study Day for Tabulations

Num

Timing

Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer.

Exp

PPNOMLBL

Label for Nominal Study Day

Char

Timing

A label for a given value of PPNOMDY as presented in the study report. Examples: "Week 4", "Day 28".

Perm

PPTPTREF

Time Point Reference

Char

Timing

Name of the fixed reference point used as a basis for PPRFTDTC.

Exp

PPRFTDTC

Date/Time of Reference Point

Char

ISO 8601 duration

Timing

Date/Time of the reference time point, PPTPTREF. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records.

Exp

PPSTINT

Start of Assessment Interval

Char

ISO 8601 duration

Timing

Start of the assessment interval relative to Time Point Reference (PPTPTREF) in ISO 8601 duration format. Example: When the area under the curve is calculated from 12 to 24 hours (PPTESTCD=AUCT1T2), the value would be PT12H.

Perm

PPENINT

End of Assessment Interval

Char

ISO 8601 duration

Timing

End of the assessment interval relative to Time Point Reference (PPTPTREF) in ISO 8601 duration format. Example: When the area under the curve is calculated from 12 to 24 hours (PPTESTCD=AUCT1T2), the value would be PT24H.

Perm