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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 SR STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 SR DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 SR USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across submission.
4 SR SRSEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 SR SRGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 SR SRREFID Reference ID Char Identifier Perm Internal or external specimen identifier. Example: "Specimen ID".
7 SR SRSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier.
8 SR SRTESTCD Skin Response Test or Exam Short Name Char C112024 Topic Req Short name of the measurement, test, or examination described in SRTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SRTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SRTESTCD cannot contain characters other than letters, numbers, or underscores.
9 SR SRTEST Skin Response Test or Examination Name Char C112023 Synonym Qualifier Req Verbatim name of the test or examination used to obtain the measurement or finding. The value in SRTEST cannot be longer than 40 characters. Example: "Wheal Diameter".
10 SR SROBJ Object of the Observation Char Record Qualifier Req Used to describe the object or focal point of the findings observation that is represented by --TEST. Examples: the dose of the immunogenic material or the allergen associated with the response (e.g., "Johnson Grass IgE 0.15 BAU mL").
11 SR SRCAT Category for Test Char Grouping Qualifier Perm Used to define a category of Topic-variable values across subjects.
12 SR SRSCAT Subcategory for Test Char Grouping Qualifier Perm A further categorization of SRCAT values.
13 SR SRORRES Results or Findings in Original Units Char Result Qualifier Exp Results of measurement or finding as originally received or collected.
14 SR SRORRESU Original Units Char C71620 Variable Qualifier Exp Original units in which the data were collected. The unit for SRORRES. Example: "mm".
15 SR SRSTRESC Character Result/Finding in Std Format Char Result Qualifier Exp Contains the result value for all findings, copied or derived from SRORRES in a standard format or in standard units. SRSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SRSTRESN.
16 SR SRSTRESN Numeric Results/Findings in Std. Units Num Result Qualifier Exp Used for continuous or numeric results or findings in standard format; copied in numeric format from SRSTRESC. SRSTRESN should store all numeric test results or findings.
17 SR SRSTRESU Standard Units Char C71620 Variable Qualifier Exp Standardized units used for SRSTRESC and SRSTRESN, Example: "mm".
18 SR SRSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate exam not done. Should be null if a result exists in SRORRES.
19 SR SRREASND Reason Not Done Char Record Qualifier Perm Describes why a measurement or test was not performed. Used in conjunction with SRSTAT when value is "NOT DONE".
20 SR SRNAM Vendor Name Char Record Qualifier Perm Name or identifier of the laboratory or vendor who provided the test results.
21 SR SRSPEC Specimen Type Char C78734 Record Qualifier Perm Defines the types of specimen used for a measurement. Example: "SKIN".
22 SR SRLOC Location Used for Measurement Char C74456 Record Qualifier Perm Location relevant to the collection of the measurement.
23 SR SRLAT Laterality Char C99073 Variable Qualifier Perm Qualifier for anatomical location further detailing laterality of intervention administration. Examples: "RIGHT", "LEFT", "BILATERAL".
24 SR SRMETHOD Method of Test or Examination Char C85492 Record Qualifier Perm Method of test or examination. Examples: "ELISA", "EIA", "MICRONEUTRALIZATION ASSAY", "PRNT" (Plaque Reduction Neutralization Tests).
25 SR SRLOBXFL 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.
26 SR SRBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. The value should be "Y" or null. Note that SRBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset.
27 SR SREVAL Evaluator Char C78735 Record Qualifier Perm Role of person who provided evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR".
28 SR VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
29 SR VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
30 SR VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
31 SR TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm.
32 SR EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time of the observation. Examples: "SCREENING", "TREATMENT", and "FOLLOW-UP".
33 SR SRDTC Date/Time of Collection Char ISO 8601 Timing Exp Collection date and time of an observation represented in ISO 8601.
34 SR SRDY Study Day of Visit/Collection/Exam Num Timing Perm Actual study day of visit/collection/exam expressed in integer days relative to sponsor- defined RFSTDTC in Demographics.
35 SR SRTPT Planned Time Point Name Char Timing Perm 1. Text description of time when measurement 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 SRTPTNUM and SRTPTREF. Examples: "Start", "5 min post".
36 SR SRTPTNUM Planned Time Point Number Num Timing Perm Numerical version of SRTPT to aid in sorting.
37 SR SRELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Planned elapsed time (in ISO 8601) relative to a fixed time point reference (SRTPTREF). Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by EGTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by SRTPTREF.
38 SR SRTPTREF Time Point Reference Char Timing Perm Name of the fixed reference point referred to by SRELTM, SRTPTNUM, and SRTPT. Example: "INTRADERMAL INJECTION".
39 SR SRRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time of the reference time point, SRTPTREF.