|
SDTMIG 3.3 |
PP |
1 |
STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
|
SDTMIG 3.3 |
PP |
2 |
DOMAIN |
Domain Abbreviation |
Char |
PP |
Identifier |
Two-character abbreviation for the domain. |
Req |
|
SDTMIG 3.3 |
PP |
3 |
USUBJID |
Unique Subject Identifier |
Char |
|
Identifier |
Unique subject identifier within the submission. |
Req |
|
SDTMIG 3.3 |
PP |
4 |
PPSEQ |
Sequence Number |
Num |
|
Identifier |
Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. |
Req |
|
SDTMIG 3.3 |
PP |
5 |
PPGRPID |
Group ID |
Char |
|
Identifier |
Used to tie together a block of related records in a single domain to support relationships within the domain and between domains. |
Perm |
|
SDTMIG 3.3 |
PP |
6 |
PPTESTCD |
Parameter Short Name |
Char |
(PKPARMCD) |
Topic |
Short name of the pharmacokinetic parameter. 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: "AUCALL", "TMAX", "CMAX". |
Req |
|
SDTMIG 3.3 |
PP |
7 |
PPTEST |
Parameter Name |
Char |
(PKPARM) |
Synonym Qualifier |
Name of the pharmacokinetic parameter. The value in PPTEST cannot be longer than 40 characters. Examples: "AUC All", "Time of CMAX", "Max Conc". |
Req |
|
SDTMIG 3.3 |
PP |
8 |
PPCAT |
Parameter Category |
Char |
|
Grouping Qualifier |
Used to define a category of related records. For PP, this should be the name of the analyte in PCTEST whose profile the parameter is associated with. |
Exp |
|
SDTMIG 3.3 |
PP |
9 |
PPSCAT |
Parameter Subcategory |
Char |
|
Grouping Qualifier |
Categorization of the model type used to calculate the PK parameters. Examples: "COMPARTMENTAL", "NON-COMPARTMENTAL". |
Perm |
|
SDTMIG 3.3 |
PP |
10 |
PPORRES |
Result or Finding in Original Units |
Char |
|
Result Qualifier |
Result of the measurement or finding as originally received or collected. |
Exp |
|
SDTMIG 3.3 |
PP |
11 |
PPORRESU |
Original Units |
Char |
(PKUNIT), (PKUWG), (PKUWKG), (PKUDMG), (PKUDUG) |
Variable Qualifier |
Original units in which the data were collected. The unit for PPORRES. Example: "ng/L". See PP Assumption 3. |
Exp |
|
SDTMIG 3.3 |
PP |
12 |
PPSTRESC |
Character Result/Finding in Std 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. |
Exp |
|
SDTMIG 3.3 |
PP |
13 |
PPSTRESN |
Numeric Result/Finding in Standard Units |
Num |
|
Result Qualifier |
Used for continuous or numeric results or findings in standard format; copied in numeric format from PPSTRESC. PPSTRESN should store all numeric test results or findings. |
Exp |
|
SDTMIG 3.3 |
PP |
14 |
PPSTRESU |
Standard Units |
Char |
(PKUNIT), (PKUWG), (PKUWKG), (PKUDMG), (PKUDUG) |
Variable Qualifier |
Standardized unit used for PPSTRESC and PPSTRESN. See PP Assumption 3 . |
Exp |
|
SDTMIG 3.3 |
PP |
15 |
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 |
|
SDTMIG 3.3 |
PP |
16 |
PPREASND |
Reason Parameter Not Calculated |
Char |
|
Record Qualifier |
Describes why a parameter was not calculated, such as "INSUFFICIENT DATA". Used in conjunction with PPSTAT when value is "NOT DONE". |
Perm |
|
SDTMIG 3.3 |
PP |
17 |
PPSPEC |
Specimen Material Type |
Char |
(SPECTYPE) |
Record Qualifier |
Defines the type of specimen used for a measurement. If multiple specimen types are used for a calculation (e.g., serum and urine for renal clearance), then this field should be left blank. Examples: "SERUM", "PLASMA", "URINE". |
Exp |
|
SDTMIG 3.3 |
PP |
18 |
TAETORD |
Planned Order of Element within Arm |
Num |
|
Timing |
Number that gives the planned order of the Element within the Arm. |
Perm |
|
SDTMIG 3.3 |
PP |
19 |
EPOCH |
Epoch |
Char |
(EPOCH) |
Timing |
Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. |
Perm |
|
SDTMIG 3.3 |
PP |
20 |
PPDTC |
Date/Time of Parameter Calculations |
Char |
ISO 8601 |
Timing |
Nominal date/time of parameter calculations. |
Perm |
|
SDTMIG 3.3 |
PP |
21 |
PPDY |
Study Day of Parameter Calculations |
Num |
|
Timing |
Study day of the collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. |
Perm |
|
SDTMIG 3.3 |
PP |
22 |
PPRFTDTC |
Date/Time of Reference Point |
Char |
ISO 8601 |
Timing |
Date/time of the reference time point from the PC records used to calculate a parameter record. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records. |
Exp |
|
SDTMIG 3.3 |
PP |
23 |
PPSTINT |
Planned Start of Assessment Interval |
Char |
ISO 8601 |
Timing |
The start of a planned evaluation or assessment interval relative to the Time Point Reference. |
Perm |
|
SDTMIG 3.3 |
PP |
24 |
PPENINT |
Planned End of Assessment Interval |
Char |
ISO 8601 |
Timing |
The end of a planned evaluation or assessment interval relative to the Time Point Reference. |
Perm |