Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 PC 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 PC 2 DOMAIN Domain Abbreviation Char PC Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 PC 3 USUBJID Unique Subject Identifier Char Identifier Unique subject identifier within the submission. Req
SDTMIG 3.3 PC 4 PCSEQ 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 PC 5 PCGRPID 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 PC 6 PCREFID Reference ID Char Identifier Internal or external specimen identifier. Perm
SDTMIG 3.3 PC 7 PCSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perm
SDTMIG 3.3 PC 8 PCTESTCD Pharmacokinetic Test Short Name Char Topic Short name of the analyte or specimen characteristic. 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. Examples: "ASA", "VOL", "SPG". Req
SDTMIG 3.3 PC 9 PCTEST Pharmacokinetic Test Name Char Synonym Qualifier Name of the analyte or specimen characteristic. Note any test normally performed by a clinical laboratory is considered a lab test. The value in PCTEST cannot be longer than 40 characters. Examples: "Acetylsalicylic Acid", "Volume", "Specific Gravity". Req
SDTMIG 3.3 PC 10 PCCAT Test Category Char Grouping Qualifier Used to define a category of related records. Examples: "ANALYTE", "SPECIMEN PROPERTY". Perm
SDTMIG 3.3 PC 11 PCSCAT Test Subcategory Char Grouping Qualifier A further categorization of a test category. Perm
SDTMIG 3.3 PC 12 PCORRES Result or Finding in Original Units Char Result Qualifier Result of the measurement or finding as originally received or collected. Exp
SDTMIG 3.3 PC 13 PCORRESU Original Units Char (PKUNIT) Variable Qualifier Original units in which the data were collected. The unit for PCORRES. Example: "mg/L". Exp
SDTMIG 3.3 PC 14 PCSTRESC Character Result/Finding in Std 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 stored in numeric format in PCSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in PCORRES, and these results effectively have the same meaning, they could be represented in standard format in PCSTRESC as "NEGATIVE". For other examples, see general assumptions. Exp
SDTMIG 3.3 PC 15 PCSTRESN 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 PCSTRESC. PCSTRESN should store all numeric test results or findings. Exp
SDTMIG 3.3 PC 16 PCSTRESU Standard Units Char (PKUNIT) Variable Qualifier Standardized unit used for PCSTRESC and PCSTRESN. Exp
SDTMIG 3.3 PC 17 PCSTAT Completion Status Char (ND) Record Qualifier Used to indicate a result was not obtained. Should be null if a result exists in PCORRES. Perm
SDTMIG 3.3 PC 18 PCREASND Reason Test Not Done Char Record Qualifier Describes why a result was not obtained, such as "SPECIMEN LOST". Used in conjunction with PCSTAT when value is "NOT DONE". Perm
SDTMIG 3.3 PC 19 PCNAM Vendor Name Char Record Qualifier Name or identifier of the laboratory or vendor who provides the test results. Exp
SDTMIG 3.3 PC 20 PCSPEC Specimen Material Type Char (SPECTYPE) Record Qualifier Defines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE". Exp
SDTMIG 3.3 PC 21 PCSPCCND Specimen Condition Char (SPECCOND) Record Qualifier Free or standardized text describing the condition of the specimen, e.g., "HEMOLYZED", "ICTERIC", "LIPEMIC". Perm
SDTMIG 3.3 PC 22 PCMETHOD Method of Test or Examination Char (METHOD) 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
SDTMIG 3.3 PC 23 PCFAST Fasting Status Char (NY) Record Qualifier Indicator used to identify fasting status. Perm
SDTMIG 3.3 PC 24 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, which do not come from the CRF, are examples of records that would be derived for the submission datasets. If PCDRVFL = "Y", then PCORRES may be null with PCSTRESC, and PCSTRESN (if the result is numeric) having the derived value. Perm
SDTMIG 3.3 PC 25 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
SDTMIG 3.3 PC 26 PCULOQ Upper Limit of Quantitation Num Variable Qualifier Indicates the upper limit of quantitation for an assay. Units should be those used in PCSTRESU. Perm
SDTMIG 3.3 PC 27 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 PC 28 VISIT Visit Name Char Timing 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 PC 29 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 PC 30 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 PC 31 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 PC 32 PCDTC Date/Time of Specimen Collection Char ISO 8601 Timing Date/time of specimen collection represented in ISO 8601 character format. If there is no end time, then this will be the collection time. Exp
SDTMIG 3.3 PC 33 PCENDTC End Date/Time of Specimen Collection Char ISO 8601 Timing End date/time of specimen collection represented in ISO 8601 character format. If there is no end time, the collection time should be stored in PCDTC, and PCENDTC should be null. Perm
SDTMIG 3.3 PC 34 PCDY Actual Study Day of Specimen Collection Num Timing 1. Study day of specimen collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. Perm
SDTMIG 3.3 PC 35 PCENDY Study Day of End of Observation Num Timing Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 PC 36 PCTPT Planned Time Point Name Char Timing 1. Text description of time when specimen should be taken. 2. 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
SDTMIG 3.3 PC 37 PCTPTNUM Planned Time Point Number Num Timing Numerical version of PCTPT to aid in sorting. Perm
SDTMIG 3.3 PC 38 PCELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned elapsed time (in ISO 8601) relative to a planned fixed reference (PCTPTREF) such as "PREVIOUS DOSE" or "PREVIOUS MEAL". This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Perm
SDTMIG 3.3 PC 39 PCTPTREF Time Point Reference Char Timing Name of the fixed reference point used as a basis for PCTPT, PCTPTNUM, and PCELTM. Example: "Most Recent Dose". Perm
SDTMIG 3.3 PC 40 PCRFTDTC Date/Time of Reference Point Char ISO 8601 Timing Date/time of the reference time point described by PCTPTREF. Perm
SDTMIG 3.3 PC 41 PCEVLINT Evaluation Interval Char ISO 8601 Timing Evaluation Interval associated with a PCTEST record represented in ISO 8601 character format. Example: "-PT2H" to represent an interval of 2 hours prior to a PCTPT. Perm