Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
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 dosing group number. | Perm |
PCREFID | Sample Identifier | Char |
| Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm |
PCSPID | Sponsorapplicant-Defined Identifier | Char |
| Identifier | SponsorApplicant-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 sponsorapplicant-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 |
| PCUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the specimen collection was unscheduled. If a specimen collection was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. | 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 datetime or interval | 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 datetime or interval | 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 sponsorapplicant-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 sponsorapplicant-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 duration | 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 datetime or interval | Timing | Date/Time of the reference time point, PCTPTREF. | Exp |
PCEVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | 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 |