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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 CP STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 CP DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 CP 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 CP CPSEQ Sequence Number Num Identifier Req Sequence number to ensure uniqueness of subject records within a domain. May be any valid number.
5 CP CPGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 CP CPREFID Reference ID Char Identifier Perm Internal or external specimen identifier.
7 CP CPSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on the lab page.
8 CP CPLNKID Link ID Char Identifier Perm Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.
9 CP CPLNKGRP Link Group ID Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
10 CP CPTESTCD Test or Examination Short Name Char C181173 Topic Req Short name of the measurement, test, or examination described in CPTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CPTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). CPTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "MONO", "MNS".
11 CP CPTEST Name of Measurement, Test or Examination Char C181174 Synonym Qualifier Req Long name for CPTESTCD. For cell phenotyping, the name (often abbreviated) of the cell population, as it is generally accepted by the scientific community, is populated (rather than a colloquial designation based on a primary marker, e.g., TLym Help rather than CD4). When the test is for a sublineage which can only be identified by specifying additional markers (i.e., has not been given a name) or which is further restricted to a subpopulation based on a particular cell state (e.g., activated, proliferating, apoptotic), the Sublineage Marker String (CPSBMRKS), Cell State (CPCELSTA), and Cell State Marker String (CPCSMRKS) variables are additionally populated and the value in CPTEST is suffixed with "Sub" to denote that it is a subset of the population identified in CPTEST (e.g., Monocytes Sub). \n The value in CPTEST cannot be longer than 40 characters.
12 CP CPSBMRKS Sublineage Marker String Char Variable Qualifier Perm Used to further subset the cell population identified in CPTEST based on the use of additional marker(s) that define a sublineage. The value in CPSBMRKS is used in combination with values in CPTEST and CPCELSTA to fully describe the cell population being measured. As such, it is an essential component of the full test name. \n For example, three unnamed sublineages of monocytes have been identified as: CCR2+CD16-, CCR2-CD16+, and CCR2+CD16+. Whereas the entire monocyte cell population can be defined as CD14+ cells, the additional CCR2 and CD16 markers are used to differentiate one sublineage from another. As none of these sublineages have been given names, they are only known by the CCR2 and CD16 marker combinations. By associating the CPTEST value of "Monocytes Sub" with, for example, a value of "CCR2+CD16-" in CPSBMRKS, the full test is defined to be the CCR2+CD16- monocyte subpopulation.
13 CP CPCELSTA Cell State Char C181172 Variable Qualifier Perm A textual description of a subset of the cell population identified in CPTEST based on a particular functional and/or biological state (e.g., "ACTIVATED", "PROLIFERATING", "SENESCENT"). When populated, the values in CPCELSTA and CPSMRKS, in combination with the values in CPTEST and CPSBMRKS, fully describe the cell population being measured.
14 CP CPCSMRKS Cell State Marker String Char Variable Qualifier Perm Identifies the marker(s) or indicator(s) used to define the cell state (i.e., the value in CPCELSTA). \n For example, when Ki67 expression is used to determine that a cell population is in a proliferating state (i.e., CPCELSTA value="PROLIFERATING"), the value "Ki67+" in CPCSMRKS indicates that positive expression of Ki67 was used to define the population as proliferating. Similarly, a value of "Ki67-" in CPCSMRKS would indicate that lack of expression of Ki67 defined the "NON-PROLIFERATING" cell state in CPCELSTA. The CPCSMRKS value is useful for quickly determining which marker(s) were used to classify (i.e., operationally define) a cell population based on a functional/biological state.
15 CP CPTSTCND Test Condition Char C181175 Variable Qualifier Perm Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed. --TSTCND is generally used to distinguish between two or more records where the same assay is performed under varying (as opposed to fixed) conditions, usually for the purpose of making a comparison. For example, when the same assay (identified in --TEST) is performed under stimulated and non-stimulated conditions, the --TSTCND variable is used distinguish between the records.
16 CP CPCNDAGT Test Condition Agent Char Record Qualifier Perm The textual description of the agent, if applicable, used to impose the condition identified in CPTSTCND. For example, records might be produced for the same assay run under stimulating (CPTSTCND value = "STIMULATED") conditions produced by different stimulating agents (e.g., phorbol myristate acetate, concanavalin A, PHA-P, TNF-alpha, Ionomycin, candida antigen).
17 CP CPBDAGNT Binding Agent Char Record Qualifier Perm The textual description of the agent that is binding to the entity in the CPTEST variable. The CPBDAGNT variable is used to indicate that there is a binding relationship between the entities in the CPTEST and CPBDAGNT variables, regardless of direction. \n The binding agent may be, but is not limited to, a test article; a portion of a test article; a substance related to a test article; an endogenous molecule; an allergen; an infectious agent; or a reagent (e.g., primary antibody) that confers the binding specificity for the measurement defined in CPTEST when it is needed to uniquely identify the test.
18 CP CPABCLID Antibody Clone Identifier Char Record Qualifier Perm Identifies the antibody clone (e.g., supplier-provided catalog name) used to confer specificity for the binding agent specified in CPBDAGNT.
19 CP CPMRKSTR Marker String Char Record Qualifier Exp The text string identifying the full set of markers/indicators used by the laboratory to operationally define the complete test based on the combination of CPTEST, CPSBMRKS, and CPCELSTA. Because laboratories often use different markers/indicators to identify a cell population, the relationship between a named cell population in CPTEST (as combined with CPSBMRKS and CPCELSTA values) and the set of markers used to identify that population is many-to-one. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different sets of markers, it is necessary to operationally define the test in terms of the complete set of markers/indicators used to perform that test.
20 CP CPGATE Gate Char Record Qualifier Perm The sponsor-defined name assigned to a gate. Gates are electronic (i.e., a device setting or software-defined) boundaries set by a user to virtually parse a specimen into discrete populations based on a set of defined characteristics (e.g., presence, absence, or intensity of expression of various markers; physical size; internal complexity or granularity). Gates are used to constrain data collection or analysis to a specific cell population or region of interest within the specimen.
21 CP CPGATDEF Gate Definition Char Record Qualifier Perm The text string identifying the set of parameters and the order in which they are applied to define the gating strategy. In practice, a series of 2-dimensional sub-gates based on different cell characteristics (i.e., markers/indicators/physical properties) are most often combined until the cell population of interest is sufficiently resolved (i.e., electronically isolated) from other cell populations contained within the specimen. \n For complex analyses, differences in gating strategies can produce subtle differences in results obtained for a test. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different gating strategies, it is often necessary to qualify the test in terms of the gating strategy. For some purposes, however, and at the discretion of the sponsor, only the ultimate or penultimate gate is identified. When specifying the gating strategy in CPGATDEF, each sub-gate should be listed in the order it was applied and separated from the next sub-gate using the pipe/vertical line ("|") character.
22 CP CPSPTSTD Sponsor Test Description Char Record Qualifier Perm Sponsor's description of a test. The variable is intended to contain highly structured test description metadata used by a sponsor to unambiguously define (label) a test. Such values generally reside in a sponsor/laboratory test metadata repository. CPSPTSTD is not intended for unstructured (spontaneous) free text. \n An example of appropriate usage is when it is necessary to include identifying information for a target cell population on which a test is conducted when the target population is not part of the test name, e.g., tests for quantitative expression of a particular marker on a specific cell population.
23 CP CPCAT Category Char C181171 Grouping Qualifier Perm Used to define a category of topic-variable values across subjects. Examples: "IMMUNOPHENOTYPING", "CELL FUNCTION", "TARGET ENGAGEMENT".
24 CP CPSCAT Subcategory Char Grouping Qualifier Perm A further categorization of CPCAT.
25 CP CPTSTPNL Test Panel Char Grouping Qualifier Perm Sponsor-defined textual description used to group tests run together as part of a test panel. Can be used with --GRPID to ensure that relationships between associated tests are accurately identified.
26 CP CPORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the measurement or finding as originally received or collected.
27 CP CPORRESU Original Units Char C71620 Variable Qualifier Perm Original units in which the data were collected. The unit for CPORRES. Examples: "10^6/L", "%", "MESF".
28 CP CPRESSCL Result Scale Char C177910 Record Qualifier Perm Classifies the scale of the original result value with respect to whether the result is quantitative, ordinal, nominal, or narrative.
29 CP CPRESTYP Result Type Char C179588 Record Qualifier Perm Classifies the kind of result (i.e., property type) originally reported for the test. Examples: "NUMBER CONCENTRATION", "NUMBER FRACTION", "RATIO".
30 CP CPCOLSRT Collected Summary Result Type Char C177908 Record Qualifier Perm Used to indicate the type of collected summary result. This includes source summary results collected on a CRF or provided by an external vendor (e.g., central lab). If the summary result is derived using individual source data records, this summary result should be represented in ADaM. If a sponsor has both a collected summary result and a derived summary result, the collected summary result should be represented in SDTM and the derived summary result should be represented in ADaM.
31 CP CPORNRLO Reference Range Lower Limit in Orig Unit Char Variable Qualifier Perm Lower end of reference range for continuous measurement in original units. Should be populated only for continuous results.
32 CP CPORNRHI Reference Range Upper Limit in Orig Unit Char Variable Qualifier Perm Upper end of reference range for continuous measurement in original units. Should be populated only for continuous results.
33 CP CPSTRESC Result or Finding in Standard Format Char Result Qualifier Exp Contains the result value for all findings, copied or derived from CPORRES in a standard format or in standard units. CPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in CPSTRESN.
34 CP CPSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Perm Used for continuous or numeric results or findings in standard format; copied in numeric format from CPSTRESC. CPSTRESN should store all numeric test results or findings.
35 CP CPSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized unit used for CPSTRESC or CPSTRESN.
36 CP CPSTNRLO Reference Range Lower Limit-Std Units Num Variable Qualifier Perm Lower end of reference range for continuous measurements for CPSTRESC/CPSTRESN in standardized units. Should be populated only for continuous results.
37 CP CPSTNRHI Reference Range Upper Limit-Std Units Num Variable Qualifier Perm Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results.
38 CP CPNRIND Reference Range Indicator Char C78736 Variable Qualifier Perm Indicates where the value falls with respect to reference range defined by CPORNRLO and CPORNRHI, CPSTNRLO and CPSTNRHI, or by CPSTNRC. Examples: "NORMAL", "ABNORMAL", "HIGH", "LOW". Sponsors should specify in the study metadata (Comments column in the Define-XML document) whether CPNRIND refers to the original or standard reference ranges and results. CPNRIND should not be used to indicate clinical significance.
39 CP CPSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate that the test was not performed or that it was attempted but did not generate a result. Should be null if a result exists in CPORRES.
40 CP CPREASND Reason Not Done Char Record Qualifier Perm Describes why a test was not performed, e.g., "BROKEN EQUIPMENT", "SUBJECT REFUSED", "SPECIMEN LOST". Used in conjunction with CPSTAT when value is "NOT DONE".
41 CP CPNAM Vendor Name Char Record Qualifier Perm The name or identifier of the laboratory that performed the test.
42 CP CPLOINC LOINC Code Char LOINC Synonym Qualifier Perm Code for the test from the LOINC code system. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes.
43 CP CPSPEC Specimen Type Char C78734 Record Qualifier Perm Defines the type of specimen used for a measurement. Examples: "BLOOD", "BONE MARROW".
44 CP CPSPCCND Specimen Condition Char C78733 Record Qualifier Perm The physical state or quality of a specimen for an assessment. Example: "CLOTTED".
45 CP CPMETHOD Method of Test or Examination Char C85492 Record Qualifier Perm Method of the test or examination. Example: "FLOW CYTOMETRY".
46 CP CPANMETH Analysis Method Char Record Qualifier Perm Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result.
47 CP CPLOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Perm Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
48 CP CPBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. The value should be "Y" or null.
49 CP CPDRVFL 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, or do not come from the CRF, or are not as originally received or collected are examples of records that might be derived for the submission datasets. If CPDRVFL = "Y", then CPORRES may be null, with CPSTRESC and (if numeric) CPSTRESN having the derived value.
50 CP CPCLSIG Clinically Significant, Collected Char C66742 Record Qualifier Perm Used to indicate whether a collected observation is clinically significant based on judgement.
51 CP VISITNUM Visit Number Num Timing Perm Clinical encounter number. Numeric version of VISIT, used for sorting.
52 CP VISIT Visit Name Char Timing Perm Protocol-defined description of clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
53 CP VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics. Should be an integer.
54 CP TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the element within the arm.
55 CP 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.
56 CP CPDTC Date/Time of Collection Char ISO 8601 datetime or interval Timing Exp Date/time of specimen collection represented in ISO 8601 character format.
57 CP CPDY Study Day of Visit/Collection/Exam Num Timing Perm Study day of specimen collection, measured in integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC value in Demographics.
58 CP CPTPT Planned Time Point Name Char Timing Perm Text description of time when a specimen is to be taken, as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point (i.e., to the value in CPTPTREF). Example: "1 hour post".
59 CP CPTPTNUM Planned Time Point Number Num Timing Perm Numerical version of CPTPT to aid in sorting. When CPTPT is represented as an elapsed time relative to a fixed reference point (i.e., to the value in CPTPTREF), the values in CPTPTNUM should be assigned in ascending order relative to the value in CPTPTREF. For example, records for time points where CPTPT = "5 minutes post", 1 hour post", and "4 hours post" could be represented in CPTPTNUM as "1", "2", and "3", which maintains the order between CPTPT and CPTPTNUM with respect to the fixed time point reference in CPTPTREF.
60 CP CPELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 duration Timing Perm Planned elapsed time relative to the planned fixed reference value in CPTPTREF, represented in ISO 8601 duration format. Examples: "-PT15M" to represent 15 minutes prior to the reference time point indicated by CPTPTREF, "T8H" to represent 8 hours after the reference time point represented by CPTPTREF.
61 CP CPTPTREF Time Point Reference Char Timing Perm Descriptive name of the fixed reference point referred to by CPTPT, CPTPTNUM, and CPELTM. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
62 CP CPRFTDTC Date/Time of Reference Time Point Char ISO 8601 datetime or interval Timing Perm Date/time for a fixed reference time point defined by CPTPTREF.