SDTM.PC

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	PC	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	PC	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	PC	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	PC	PCSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	PC	PCGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain to support relationships within the domain and between domains.
6	PC	PCREFID	Reference ID	Char		Identifier	Perm	Internal or external specimen identifier.
7	PC	PCSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number.
8	PC	PCTESTCD	Pharmacokinetic Test Short Name	Char		Topic	Req	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".
9	PC	PCTEST	Pharmacokinetic Test Name	Char		Synonym Qualifier	Req	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".
10	PC	PCCAT	Test Category	Char		Grouping Qualifier	Perm	Used to define a category of related records. Examples: "ANALYTE", "SPECIMEN PROPERTY".
11	PC	PCSCAT	Test Subcategory	Char		Grouping Qualifier	Perm	A further categorization of a test category.
12	PC	PCORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the measurement or finding as originally received or collected.
13	PC	PCORRESU	Original Units	Char	C85494	Variable Qualifier	Exp	Original units in which the data were collected. The unit for PCORRES. Example: "mg/L".
14	PC	PCSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	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.
15	PC	PCSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Exp	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.
16	PC	PCSTRESU	Standard Units	Char	C85494	Variable Qualifier	Exp	Standardized unit used for PCSTRESC and PCSTRESN.
17	PC	PCSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate a result was not obtained. Should be null if a result exists in PCORRES.
18	PC	PCREASND	Reason Test Not Done	Char		Record Qualifier	Perm	Describes why a result was not obtained, such as "SPECIMEN LOST". Used in conjunction with PCSTAT when value is "NOT DONE".
19	PC	PCNAM	Vendor Name	Char		Record Qualifier	Exp	Name or identifier of the laboratory or vendor who provides the test results.
20	PC	PCSPEC	Specimen Material Type	Char	C78734	Record Qualifier	Exp	Defines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE".
21	PC	PCSPCCND	Specimen Condition	Char	C78733	Record Qualifier	Perm	Free or standardized text describing the condition of the specimen. Examples: "HEMOLYZED", "ICTERIC", "LIPEMIC".
22	PC	PCMETHOD	Method of Test or Examination	Char	C85492	Record Qualifier	Perm	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.
23	PC	PCFAST	Fasting Status	Char	C66742	Record Qualifier	Perm	Indicator used to identify fasting status.
24	PC	PCDRVFL	Derived Flag	Char	C66742	Record Qualifier	Perm	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.
25	PC	PCLLOQ	Lower Limit of Quantitation	Num		Variable Qualifier	Exp	Indicates the lower limit of quantitation for an assay. Units should be those used in PCSTRESU.
26	PC	PCULOQ	Upper Limit of Quantitation	Num		Variable Qualifier	Perm	Indicates the upper limit of quantitation for an assay. Units should be those used in PCSTRESU.
27	PC	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
28	PC	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
29	PC	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
30	PC	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the element within the arm.
31	PC	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.
32	PC	PCDTC	Date/Time of Specimen Collection	Char	ISO 8601 datetime or interval	Timing	Exp	Date/time of specimen collection represented in ISO 8601 character format. If there is no end time, then this will be the collection time.
33	PC	PCENDTC	End Date/Time of Specimen Collection	Char	ISO 8601 datetime or interval	Timing	Perm	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.
34	PC	PCDY	Actual Study Day of Specimen Collection	Num		Timing	Perm	Study day of specimen collection, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.
35	PC	PCENDY	Study Day of End of Observation	Num		Timing	Perm	Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
36	PC	PCTPT	Planned Time Point Name	Char		Timing	Perm	Text description of time when specimen should be taken. 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".
37	PC	PCTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numerical version of PCTPT to aid in sorting.
38	PC	PCELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing	Perm	Planned elapsed time (in ISO 8601) relative to a planned fixed reference (PCTPTREF; e.g., "PREVIOUS DOSE", "PREVIOUS MEAL"). This variable is useful where there are repetitive measures. Not a clock time or a date time variable.
39	PC	PCTPTREF	Time Point Reference	Char		Timing	Perm	Name of the fixed reference point used as a basis for PCTPT, PCTPTNUM, and PCELTM. Example: "MOST RECENT DOSE".
40	PC	PCRFTDTC	Date/Time of Reference Point	Char	ISO 8601 datetime or interval	Timing	Perm	Date/time of the reference time point described by PCTPTREF.
41	PC	PCEVLINT	Evaluation Interval	Char	ISO 8601 duration or interval	Timing	Perm	Evaluation Interval associated with a PCTEST record represented in ISO 8601 character format. Example: "-PT2H" to represent an evaluation interval of 2 hours prior to a PCTPT.