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. |