| 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 (e.g., "1TEST" is not valid). 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. Example: "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 Result/Finding 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.
Example: "SKIN". |
Perm |
| SRLOC |
Location Used for Measurement |
Char |
Record Qualifier |
Location relevant to the collection of the measurement. |
Perm |
| SRLAT |
Laterality |
Char |
Variable 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. Examples: "ELISA", "EIA",
"MICRONEUTRALIZATION ASSAY", "PRNT" (Plaque Reduction Neutralization
Tests). |
Perm |
| SRLOBXFL |
Last Observation Before Exposure Flag |
Char |
Record Qualifier |
Operationally-derived indicator used to identify the last
non-missing value prior to RFXSTDTC. The value should be "Y" or
null. |
Perm |
| SRBLFL |
Baseline Flag |
Char |
Record Qualifier |
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. |
Perm |
| SREVAL |
Evaluator |
Char |
Record Qualifier |
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". |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
Protocol-defined description of clinical encounter. 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 |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the date/time of the observation.
Examples: "SCREENING", "TREATMENT", and "FOLLOW-UP". |
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 |
Text description of time when measurement should be taken.
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 |