| 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 |
| FOCID |
Focus of Study-Specific Interest |
Char |
Identifier |
Identification of a focus of study-specific interest on or
within a subject or specimen as called out in the protocol for which
a measurement, test, or examination was performed. |
Perm |
| OESEQ |
Sequence Number |
Num |
Identifier |
Sequence number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| OEGRPID |
Group ID |
Char |
Identifier |
Optional group identifier, used to link together a block of
related records within a subject in a domain. |
Perm |
| OELNKID |
Link ID |
Char |
Identifier |
Identifier used to link related records across domains. This
may be a one-to-one or a one-to-many relationship. |
Perm |
| OELNKGRP |
Link Group |
Char |
Identifier |
Identifier used to link related records across domains. This
will usually be a many-to-one relationship. |
Perm |
| OETESTCD |
Short Name of Ophthalmic Test or Exam |
Char |
Topic |
Short character value for OETEST used as a column name when
converting a dataset from a vertical format to a horizontal format.
It can be used as a column name when converting a dataset from a
vertical to a horizontal format. The value in OETESTCD cannot be
longer than 8 characters, nor can it start with a number (e.g.,
"1TEST" is not valid). OETESTCD cannot contain characters other than
letters, numbers, or underscores. Example: "NUMLCOR". |
Req |
| OETEST |
Name of Ophthalmic Test or Exam |
Char |
Synonym Qualifier |
Long name for the test or examination used to obtain the
measurement or finding. The value in OETEST cannot be longer than 40
characters. Example: Number of Letters Correct for OETESTCD =
"NUMLCOR". |
Req |
| OETSTDTL |
Ophthalmic Test or Exam Detail |
Char |
Variable Qualifier |
Further description of OETESTCD and OETEST. |
Perm |
| OECAT |
Category for Ophthalmic Test or Exam |
Char |
Grouping Qualifier |
Used to define a category of topic-variable values.
Examples: "VISUAL ACUITY", "CONTRAST SENSITIVIY", "OCULAR COMFORT".
|
Perm |
| OESCAT |
Subcategory for Ophthalmic Test or Exam |
Char |
Grouping Qualifier |
Used to define a further categorization of OECAT values.
Examples: "HIGH CONTRAST" and "LOW CONTRAST" when OECAT is "VISUAL
ACUITY". |
Perm |
| OEORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the measurement or finding as originally received
or collected. Examples: "120", "<1, NORMAL", "RED SPOT VISIBLE".
|
Exp |
| OEORRESU |
Original Units |
Char |
Variable Qualifier |
Original unit for OEORRES. Examples: "mm", "um". |
Exp |
| OEORNRLO |
Normal Range Lower Limit-Original Units |
Char |
Variable Qualifier |
Lower end of normal range or reference range for results
stored in OEORRES. |
Perm |
| OEORNRHI |
Normal Range Upper Limit-Original Units |
Char |
Variable Qualifier |
Upper end of normal range or reference range for results
stored in OEORRES. |
Perm |
| OESTRESC |
Character Result/Finding in Std Format |
Char |
Result Qualifier |
Contains the result value for all findings, copied or
derived from OEORRES in a standard format or in standard units.
OESTRESC should store all results or findings in character format;
if results are numeric, they should also be stored in numeric format
in OESTRESN. |
Exp |
| OESTRESN |
Numeric Result/Finding in Standard Units |
Num |
Result Qualifier |
Used for continuous or numeric results or findings in
standard format; copied in numeric format from OESTRESC. OESTRESN
should store all numeric test results or findings. |
Exp |
| OESTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized units used for OESTRESC and OESTRESN. Examples:
"mm", "um". |
Exp |
| OESTNRLO |
Normal Range Lower Limit-Standard Units |
Num |
Variable Qualifier |
Lower end of normal range or reference range for
standardized results (e.g., OESTRESC, OESTRESN) represented in
standardized units (OESTRESU). |
Perm |
| OESTNRHI |
Normal Range Upper Limit-Standard Units |
Num |
Variable Qualifier |
Upper end of normal range or reference range for
standardized results (e.g., OESTRESC, OESTRESN) represented in
standardized units (OESTRESU). |
Perm |
| OESTNRC |
Normal Range for Character Results |
Char |
Variable Qualifier |
Normal range or reference range for results stored in
OESTRESC that are character in ordinal or categorical scale.
Example: "Negative to Trace". |
Perm |
| OENRIND |
Normal/Reference Range Indicator |
Char |
Variable Qualifier |
Used to indicate the value is outside the normal range or
reference range. May be defined by OEORNRLO and OEORNRHI or other
objective criteria. Examples: "Y", "N"; "HIGH", "LOW", "NORMAL",
"ABNORMAL". |
Perm |
| OERESCAT |
Result Category |
Char |
Variable Qualifier |
Used to categorize the result of a finding or medical status
per interpretation of test results. Examples: "POSITIVE",
"NEGATIVE". The variable OERESCAT is not meant to replace the use of
OENRIND for cases where normal ranges are provided. |
Perm |
| OESTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate that a question was not asked or a test was
not done, or a test was attempted but did not generate a result.
Should be null or have a value of "NOT DONE". |
Perm |
| OEREASND |
Reason Not Done |
Char |
Record Qualifier |
Reason not done. Used in conjunction with OESTAT when value
is "NOT DONE". |
Perm |
| OEXFN |
External File Path |
Char |
Record Qualifier |
Filename for an external file, such as one for a retinal OCT
image. |
Perm |
| OELOC |
Location Used for the Measurement |
Char |
Record Qualifier |
Anatomical location of the subject relevant to the
collection of the measurement. Examples: "EYE" for a finding record
relative to the complete eye, "RETINA" for a measurement or
assessment of only the retina. |
Exp |
| OELAT |
Laterality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". |
Exp |
| OEDIR |
Directionality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
|
Perm |
| OEPORTOT |
Portion or Totality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing the distribution, which means arrangement of, apportioning
of. Examples: "ENTIRE", "SINGLE", "SEGMENT", "MANY". |
Perm |
| OEMETHOD |
Method of Test or Examination |
Char |
Record Qualifier |
Method of the test or examination. Example: "ETDRS EYE
CHART" for OETESTCD = "NUMLCOR". The different methods may offer
different functionality or granularity, affecting the set of results
and associated meaning. |
Exp |
| OELOBXFL |
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. |
Exp |
| OEBLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. Should be "Y"
or null. Note that OEBLFL is retained for backward compatibility.
The authoritative baseline for statistical analysis is in an ADaM
dataset. |
Perm |
| OEDRVFL |
Derived Flag |
Char |
Record Qualifier |
Used to indicate a derived record (e.g., a record that
represents the average of other records such as a computed
baseline). Should be "Y" or null. |
Perm |
| OEEVAL |
Evaluator |
Char |
Record Qualifier |
Role of the person who provided the evaluation. Used only
for results that are subjective (e.g., assigned by a person or a
group). Examples: "INDEPENDENT ASSESSOR", "INVESTIGATOR". |
Perm |
| OEEVALID |
Evaluator Identifier |
Char |
Variable Qualifier |
Used to distinguish multiple evaluators with the same role
recorded in OEEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2". |
Perm |
| OEACPTFL |
Accepted Record Flag |
Char |
Record Qualifier |
In cases where more than one assessor provides an evaluation
of a result or response, this flag identifies the record that is
considered, by an independent assessor, to be the accepted
evaluation. Expected to be "Y" or null. |
Perm |
| OEREPNUM |
Repetition Number |
Num |
Record Qualifier |
The incidence number of a test that is repeated within a
given timeframe for the same test. The level of granularity can
vary, e.g., within a time point or within a visit. For example,
multiple measurements of blood pressure or multiple analyses of a
sample. |
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 a clinical encounter. |
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 for the Element in which the assessment was made. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the date/time at which the assessment
was made. |
Perm |
| OEDTC |
Date/Time of Collection |
Char |
Timing |
Collection date/time of the observation. |
Exp |
| OEDY |
Study Day of Visit/Collection/Exam |
Num |
Timing |
Actual study day of observation/exam expressed in integer
days relative to the sponsor-defined RFSTDTC in Demographics. |
Exp |
| OETPT |
Planned Time Point Name |
Char |
Timing |
Text description of time when a measurement or observation
should be taken as defined in the protocol. This may be represented
as an elapsed time relative to a fixed reference point. |
Perm |
| OETPTNUM |
Planned Time Point Number |
Num |
Timing |
Numeric version of planned time point used in sorting. |
Perm |
| OEELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
Planned elapsed time relative to a planned fixed reference
(OETPTREF) such as "Previous Dose" or "Previous Meal". This variable
is useful where there are repetitive measures. Not a clock time or a
date/time variable, but an interval, represented as ISO duration. |
Perm |
| OETPTREF |
Time Point Reference |
Char |
Timing |
Description of the fixed reference point referred to by
OETPT, OETPTNUM, and OEELTM. |
Perm |
| OERFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time of the reference time point, OETPTREF. |
Perm |