| 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 |
| MOSEQ |
Sequence Number |
Num |
Identifier |
Sequence number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| MOGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| MOREFID |
Reference ID |
Char |
Identifier |
Internal or external procedure identifier. |
Perm |
| MOSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined reference number. Perhaps preprinted on the
CRF as an explicit line identifier or defined in the sponsor's
operational database. Example: Line number from the procedure or
test page. |
Perm |
| MOLNKID |
Link ID |
Char |
Identifier |
Identifier used to link results of a procedure to the
procedure performed. |
Perm |
| MOTESTCD |
Test or Examination Short Name |
Char |
Topic |
Short name of the measurement, test, or examination
described in MOTEST. It can be used as a column name when converting
a dataset from a vertical to a horizontal format. The value in
MOTESTCD cannot be longer than 8 characters, nor can it start with a
number (e.g., "1TEST" is not valid). MOTESTCD cannot contain
characters other than letters, numbers, or underscores. Examples:
"VOLUME", "INTP". |
Req |
| MOTEST |
Test or Examination Name |
Char |
Synonym Qualifier |
Verbatim name of the test or examination used to obtain the
measurement or finding. The value in MOTEST cannot be longer than 40
characters. Examples: "Volume", "Interpretation". |
Req |
| MOCAT |
Category for Test |
Char |
Grouping Qualifier |
Used to categorize observations across subjects. |
Perm |
| MOSCAT |
Subcategory for Test |
Char |
Grouping Qualifier |
A further categorization. |
Perm |
| MOPOS |
Position of Subject |
Char |
Record Qualifier |
Position of the subject during a measurement or examination.
Examples: "SUPINE", "STANDING", "SITTING". |
Perm |
| MOORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the procedure measurement or finding as originally
received or collected. |
Exp |
| MOORRESU |
Original Units |
Char |
Variable Qualifier |
Original units in which the data were collected. The unit
for MOORRES. |
Perm |
| MOSTRESC |
Character Result/Finding in Std Format |
Char |
Result Qualifier |
Contains the result value for all findings, copied or
derived from MOORRES in a standard format or standard units.
MOSTRESC should store all results or findings in character format;
if results are numeric, they should also be stored in numeric format
in MOSTRESN. |
Exp |
| MOSTRESN |
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 MOSTRESC. MOSTRESN
should store all numeric test results or findings. |
Perm |
| MOSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized unit used for MOSTRESC or MOSTRESN. |
Perm |
| MOSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate a test was not done, or a measurement was
not taken. Should be null if a result exists in MOORRES. |
Perm |
| MOREASND |
Reason Test Not Performed |
Char |
Record Qualifier |
Describes why a measurement or test was not performed.
Examples: "BROKEN EQUIPMENT" or "SUBJECT REFUSED". Used in
conjunction with MOSTAT when value is "NOT DONE". |
Perm |
| MOXFN |
External File Path |
Char |
Record Qualifier |
File path to the external file. |
Perm |
| MONAM |
Vendor Name |
Char |
Record Qualifier |
Name or identifier of the laboratory or vendor who provided
the test results. |
Perm |
| MOLOC |
Location Used for Measurement |
Char |
Record Qualifier |
Location relevant to the collection of the measurement.
Examples: "BRAIN", "KIDNEY", "LIVER", etc. |
Perm |
| MOLAT |
Specimen Laterality within Subject |
Char |
Variable Qualifier |
Qualifier for laterality of the specimen within the subject
for paired specimens. Examples: "LEFT", "RIGHT", "BILATERAL". |
Perm |
| MODIR |
Specimen Directionality within Subject |
Char |
Variable Qualifier |
Qualifier for directionality of the specimen within the
subject. Examples: "DORSAL", "PROXIMAL". |
Perm |
| MOPORTOT |
Portion or Totality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing the portion of totality which means arrangement of, or
apportioning of. Examples: "ENTIRE", "PARTIAL". |
Perm |
| MOMETHOD |
Method of Procedure Test |
Char |
Record Qualifier |
Method of the test or examination result. |
Perm |
| MOANMETH |
Analysis Method |
Char |
Record Qualifier |
Analysis method applied to obtain a summarized result.
Example: "STEREOLOGY". |
Perm |
| MOLOBXFL |
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 |
| MOBLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. The value
should be "Y" or "null". Note that MOBLFL is retained for backward
compatibility. The authoritative baseline flag for statistical
analysis is in an ADaM dataset. |
Exp |
| MODRVFL |
Derived Flag |
Char |
Record Qualifier |
Used to indicate a derived record. The value should be "Y"
or null. Records that represent the average of other records, or
that do not come from the CRF, or are not as originally collected or
received are examples of records that would be derived for the
submission datasets. If MODRVFL = "Y", then MOORRES could be null,
and (if numeric) MOSTRESN have the derived value. |
Perm |
| MOEVAL |
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). 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 for the Element in which the assessment was made. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the date/time at which the observation
was made. |
Perm |
| MODTC |
Date/Time of Test |
Char |
Timing |
Date of test. |
Exp |
| MODY |
Study Day of Test |
Num |
Timing |
Study day of the procedure or test, measured as integer
days. Algorithm for calculations must be relative to the
sponsor-defined RFSTDTC variable in Demographics. |
Perm |
| MOTPT |
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 MOTPTNUM and
MOTPTREF. Examples: "Start", "5 min post". |
Perm |
| MOTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numerical version of MOTPT to aid in sorting. |
Perm |
| MOELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
Planned elapsed time (in ISO 8601) relative to a fixed time
point reference (MOTPTREF). 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 MOTPTREF, or "PT8H" to represent the period of 8 hours
after the reference point indicated by MOTPTREF. |
Perm |
| MOTPTREF |
Time Point Reference |
Char |
Timing |
Name of the fixed reference point referred to by MOELTM,
MOTPTNUM, and MOTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". |
Perm |
| MORFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time of the reference time point, MOTPTREF. |
Perm |