| 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 all
studies for all applications or submissions involving the product. |
Req |
| ISSEQ |
Sequence Number |
Num |
Identifier |
Sequence number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| ISGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| ISREFID |
Reference ID |
Char |
Identifier |
Internal or external specimen identifier. Example:
"458975-01". |
Perm |
| ISSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined identifier. |
Perm |
| ISTESTCD |
Immunogenicity Test/Exam Short Name |
Char |
Topic |
Short name of the measurement, test, or examination
described in ISTEST. It can be used as a column name when converting
a dataset from a vertical to a horizontal format. The value in
ISTESTCD cannot be longer than 8 characters, nor can it start with a
number (e.g., "1TEST" is not valid). ISTESTCD cannot contain
characters other than letters, numbers, or underscores. |
Req |
| ISTEST |
Immunogenicity Test or Examination Name |
Char |
Synonym Qualifier |
Verbatim name of the test or examination used to obtain the
measurement or finding. The value in ISTEST cannot be longer than 40
characters. Example: "Immunoglobulin E". |
Req |
| ISCAT |
Category for Immunogenicity Test |
Char |
Synonym Qualifier |
Used to define a category of Topic-variable values across
subjects. Example: "SEROLOGY". |
Perm |
| ISSCAT |
Subcategory for Immunogenicity Test |
Char |
Grouping Qualifier |
A further categorization of ISCAT. |
Perm |
| ISORRES |
Results or Findings in Original Units |
Char |
Result Qualifier |
Result of measurement or finding as originally received or
collected. |
Exp |
| ISORRESU |
Original Units |
Char |
Variable Qualifier |
Original units in which the data were collected. The unit
for ISORRES. Examples: "Index Value", "gpELISA", "unit/mL". |
Exp |
| ISSTRESC |
Character Result/Finding in Std Format |
Char |
Result Qualifier |
Contains the result value for all findings, copied or
derived from ISORRES, in a standard format or in standard units.
ISSTRESC should store all results or findings in character format;
if results are numeric, they should also be stored in numeric format
in ISSTRESN. |
Exp |
| ISSTRESN |
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 ISSTRESC. ISSTRESN
should store all numeric test results or findings. |
Exp |
| ISSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized units used for ISSTRESC and ISSTRESN. Examples:
"Index Value", "gpELISA", "unit/mL". |
Exp |
| ISSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate a test was not done. Should be null if a
result exists in ISORRES. |
Perm |
| ISREASND |
Reason Not Done |
Char |
Record Qualifier |
Describes why a measurement or test was not performed. Used
in conjunction with ISSTAT when value is "NOT DONE". |
Perm |
| ISNAM |
Vendor Name |
Char |
Record Qualifier |
Name or identifier of the laboratory or vendor who provided
the test results. |
Perm |
| ISSPEC |
Specimen Type |
Char |
Record Qualifier |
Defines the types of specimen used for a measurement.
Example: "SERUM". |
Perm |
| ISMETHOD |
Method of Test or Examination |
Char |
Record Qualifier |
Method of the test or examination. Examples: "ELISA",
"ELISPOT". |
Perm |
| ISLOBXFL |
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 |
| ISBLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. Should be "Y"
or null. Note that ISBLFL is retained for backward compatibility.
The authoritative baseline for statistical analysis is in an ADaM
dataset. |
Perm |
| ISLLOQ |
Lower Limit of Quantitation |
Num |
Variable Qualifier |
Indicates the lower limit of quantitation for an assay.
Units will be those used for ISSTRESU. |
Exp |
| 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 a 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 start date/time of the
observation, or the date/time of collection if start date/time is
not collected. |
Perm |
| ISDTC |
Date/Time of Collection |
Char |
Timing |
Collection date and time of an observation represented in
ISO 8601. |
Exp |
| ISDY |
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 |