PC Specification (v3.1.1 Copy)

STUDYID

Study Identifier

Char

Identifier

Unique identifier for a study.

Req

DOMAIN

Domain Abbreviation

Char

PC

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

PCSEQ

Sequence Number

Num

Identifier

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

Req

PCGRPID

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

PCREFID

Sample Identifier

Char

Identifier

Internal or external specimen identifier. Example: 1009570101.

Perm

PCSPID

Sponsor-Defined Identifier

Char

Identifier

Sponsor-defined reference identifier.

Perm

PCTESTCD

Test Short Name

Char

Topic

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

Req

PCTEST

Test Name

Char

Synonym Qualifier

Long name for PCTESTCD, such as the name of the analyte (or measurement). The value in PCTEST cannot be longer than 40 characters.

Req

PCCAT

Test Category

Char

Grouping Qualifier

Used to define a category of the pharmacokinetic test performed. Examples: ANALYTE, METABOLITE, SPECIMEN PROPERTY.

Perm

PCSCAT

Test Subcategory

Char

Grouping Qualifier

A further categorization of a test category.

Perm

PCORRES

Result or Findings as Collected

Char

Result Qualifier

Result of the measurement or finding as originally received or collected.

Exp

PCORRESU

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 Controlled Terminology (http://www.cdisc.org/terminology) list.

Exp

PCSTRESC

Standardized Result in Character Format

Char

Result Qualifier

Contains the result value for all findings, copied or derived from PCORRES in a standard format or standard units. PCSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in PCSTRESN. Results beyond limits of quantitation should be represented with the term "BLQ" for results below the limit and "ALQ" for results above the limit.

Exp

PCSTRESN

Standardized Result in Numeric Format

Num

Result Qualifier

Used for numeric results or findings in standard format; contains the numeric form of PCSTRESC. PCSTRESN should store all numeric test results or findings. For results beyond limits of quantitation, this variable should be left null (e.g., if PCSTRESC is "BLQ", PCSTRESN would be null).

Exp

PCSTRESU

Unit of the Standardized Result

Char

(PKUNIT)

Variable Qualifier

Standardized unit used for PCSTRESC and PCSTRESN.

Exp

PCSTAT

Completion Status

Char

(ND)

Record Qualifier

Used to indicate when a test is not done or result is missing. Should be null if a result exists in PCORRES.

Perm

PCREASND

Reason Not Done

Char

Record Qualifier

Describes why PCSTAT is NOT DONE, such as SPECIMEN LOST.

Perm

PCNAM

Laboratory Name

Char

Record Qualifier

Name or identifier of the laboratory or vendor providing the test results.

Perm

PCSPEC

Specimen Material Type

Char

(SPEC)

Record Qualifier

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

Req

PCSPCCND

Specimen Condition

Char

Record Qualifier

Free or standardized text describing the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC.

Perm

PCSPCUFL

Specimen Usability for the Test

Char

(NY)

Record Qualifier

Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null.

Perm

PCMETHOD

Method of Test or Examination

Char

Record Qualifier

Method of the test or examination. Examples: HPLC/MS, ELISA. This should contain sufficient information and granularity to allow differentiation of various methods that might have been used within a study.

Perm

PCBLFL

Baseline Flag

Char

(NY)

Record Qualifier

A baseline indicator may be used to calculate differences or changes from baseline. Value should be "Y" or null. The baseline flag is sponsor-defined.

Perm

PCFAST

Fasting Status

Char

(NY)

Record Qualifier

Indicator used to identify fasting status. The value should be "Y" or null.

Perm

PCDRVFL

Derived Flag

Char

(NY)

Record Qualifier

Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records are examples of records that would be derived for the submission datasets.

Perm

PCLLOQ

Lower Limit of Quantitation

Num

Variable Qualifier

Indicates the lower limit of quantitation for an assay. Units should be those used in PCSTRESU.

Exp

PCEXCLFL

Exclusion Flag

Char

(NY)

Record Qualifier

"Y" if the result should be excluded from all calculations, otherwise null.

Perm

PCREASEX

Reason for Exclusion

Char

Record Qualifier

The reason the result should be excluded from all calculations. Used only when PCEXCLFL is "Y".

Perm

VISITDY

Planned Study Day of Collection

Num

Timing

Planned day of collection. Should be an integer.

Perm

PCDTC

Date/Time of Specimen Collection

Char

ISO 8601

Timing

Date/Time of specimen collection, in ISO 8601 format. If there is no end time, this will be the collection time.

Perm

PCENDTC

End Date/Time of Specimen Collection

Char

ISO 8601

Timing

End date/time of specimen collection, in ISO 8601 format. If there is no end time, the collection time should be represented in PCDTC, and PCENDTC should be null.

Perm

PCDY

Study Day of Specimen Collection

Num

Timing

Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics (DM) domain.

Perm

PCENDY

Study Day of End of Specimen Collection

Num

Timing

Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in DM domain.

Perm

PCNOMDY

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

PCNOMLBL

Label for Nominal Study Day

Char

Timing

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

Perm

PCTPT

Planned Time Point Name

Char

Timing

Text description of time when specimen should be taken.

Note: This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See PCTPTNUM and PCTPTREF. Examples: Start, 5 min post.

Perm

PCTPTNUM

Planned Time Point Number

Num

Timing

Numerical version of PCTPT to aid in sorting.

Perm

PCELTM

Planned Elapsed Time from Time Point Ref

Char

ISO 8601

Timing

Planned elapsed time (in ISO 8601 format) relative to a planned fixed reference (PCTPTREF) such as "Day 1, Dose 1". This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "PT0H" to represent any predose values; "PT8H" to represent the period of 8 hours after the reference point indicated by PCTPTREF.

Exp

PCTPTREF

Time Point Reference

Char

Timing

Name of the fixed reference point referred to by PCELTM, if used for PCTPTNUM, and PCTPT. It is recommended that PCTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Example: "Day 1, Dose 1".

Exp

PCRFTDTC

Date/Time of Reference Point

Char

ISO 8601

Timing

Date/Time of the reference time point, PCTPTREF.

Exp

PCEVLINT

Evaluation Interval

Char

ISO 8601

Timing

Planned evaluation interval associated with a PCTEST record in ISO 8601 format. Example: "-P2H" to represent a planned interval of collection of 2 hours prior to the time point described in PCTPT.

Perm