| STUDYID |
Study Identifier |
Char |
Identifier |
Unique Identifier for a Study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
Identifier |
Two-character abbreviation for the domain. |
Req |
| USUBJID |
Unique Subject Identifier |
Char |
Identifier |
Identifier used to uniquely identify a subject across
submission. |
Req |
| SRSEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| SRGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a
single domain for a subject. |
Perm |
| SRREFID |
Reference ID |
Char |
Identifier |
Internal or external specimen identifier. Example:
Specimen ID. |
Perm |
| SRSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor defined identifier. |
Perm |
| SRTESTCD |
Skin Response Test or Exam Short Name |
Char |
Topic |
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. SRTESTCD cannot contain characters other than letters, numbers, or underscores. |
Req |
| SRTEST | Skin Response Test or Examination Name | Char | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in SRTEST cannot be longer than 40 characters. (E.g., Wheal Diameter). | Req |
| SROBJ | Object of the Observation | Char | Record Qualifier | 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). | Req |
| SRCAT |
Category for Test |
Char |
Grouping Qualifier |
Used to define a category of Topic-variable values across
subjects. |
Perm |
| SRSCAT |
Subcategory for Test |
Char |
Grouping Qualifier |
A further categorization of SRCAT values. |
Perm |
| SRORRES |
Results or Findings in Original Units |
Char |
Result Qualifier |
Results of measurement or finding as originally received
or collected. |
Exp |
| SRORRESU |
Original Units |
Char |
Variable Qualifier |
Original units in which the data were collected. The unit
for SRORRES. Example: mm. |
Exp |
| SRSTRESC |
Character Results/Findings in Std. Format |
Char |
Result Qualifier |
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. |
Exp |
| SRSTRESN | Numeric Results/Findings in Std. Units | Num | Result Qualifier | 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. | Exp |
| SRSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized units used for SRSTRESC and SRSTRESN,
Example: mm. |
Exp |
| SRSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate exam not done. Should be null if a result
exists in SRORRES. |
Perm |
| SRREASND |
Reason Not Done |
Char |
Record Qualifier |
Describes why a measurement or test was not performed.
Used in conjunction with SRSTAT when value is NOT DONE. |
Perm |
| SRNAM |
Vendor Name |
Char |
Record Qualifier |
Name or identifier of the laboratory or vendor who
provided the test results |
Perm |
| SRSPEC |
Specimen Type |
Char |
Record Qualifier |
Defines the types of specimen used for a measurement.
E.g., SKIN. |
Perm |
| SRLOC |
Location used for Measurement |
Char |
Record Qualifier |
Location relevant to the collection of the measurement. |
Perm |
| SRLAT |
Laterality |
Char |
Result Qualifier |
Qualifier for anatomical location further detailing
laterality of intervention administration. Examples: RIGHT, LEFT,
BILATERAL |
Perm |
| SRMETHOD |
Method of Test or Examination |
Char |
Record Qualifier |
Method of test or examination (ELISA, EIA
Microneutralization, PRNT (Plaque Reduction Neutralization Tests)
|
Perm |
| SREVAL | Evaluator | Char | Record Qualifier | | Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
1. Clinical encounter number. 2. Numeric version of VISIT,
used for sorting |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
1. Protocol-defined description of clinical encounter 2.
May be used in addition to VISITNUM and/or VISITDY |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of the visit based upon RFSTDTC in
Demographics. |
Perm |
| SRDTC |
Date/Time of Collection |
Char |
Timing |
Collection date and time of an observation represented in
ISO 8601 |
Exp |
| SRDY |
Study Day of Visit/Collection/Exam |
Num |
Timing |
Actual study day of visit/collection/exam expressed in
integer days relative to sponsor- defined RFSTDTC in Demographics
|
Perm |
| SRTPT | Planned Time Point Name | Char | Timing | 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. | Perm |
| SRTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numerical version of SRTPT to aid in sorting. |
Perm |
| SRELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
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. |
Perm |
| SRTPTREF |
Time Point Reference |
Char |
Timing |
Name of the fixed reference point referred to by SRELTM,
SRTPTNUM, and SRTPT. Example: INTRADERMAL INJECTION. |
Perm |
| SRRFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time of the reference time point, SRTPTREF. |
Perm |