| 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 |
| MLSEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| MLGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| MLSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined reference number. Examples: a number
pre-printed on the CRF as an explicit line identifier or record
identifier defined in the sponsor's operational database. |
Perm |
| MLTRT |
Name of Meal |
Char |
Topic |
Verbatim food product name that is either pre-printed or
collected on a CRF. |
Req |
| MLCAT |
Category for Meal |
Char |
Grouping Qualifier |
Used to define a category of MLTRT values. |
Perm |
| MLSCAT |
Subcategory for Meal |
Char |
Grouping Qualifier |
Used to define a further categorization of MLCAT values. |
Perm |
| MLPRESP |
ML Pre-specified |
Char |
Variable Qualifier |
Used when a specific meal is pre-specified on a CRF. Values
should be "Y" or null. |
Perm |
| MLOCCUR |
ML Occurrence |
Char |
Record Qualifier |
Used to record whether a pre-specified meal occurred when
information about the occurrence of a specific meal is solicited. |
Perm |
| MLSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate when a question about the occurrence of a
pre-specified meal was not answered. Should be null or have a value
of "NOT DONE". |
Perm |
| MLREASND |
Reason Meal Not Collected |
Char |
Record Qualifier |
Describes the reason a response to a question about the
occurrence of a meal was not collected. Used in conjunction with
MLSTAT when value is "NOT DONE". |
Perm |
| MLDOSE |
Dose |
Num |
Record Qualifier |
Amount of MLTRT consumed. Not populated when MLDOSTXT is
populated. |
Perm |
| MLDOSTXT |
Dose Description |
Char |
Record Qualifier |
Amount description of MLTRT consumed, collected in text
form. Not populated when MLDOSE is populated. Examples: "<1 per
day", "200-400". |
Perm |
| MLDOSU |
Dose Units |
Char |
Variable Qualifier |
Units for MLDOSE, MLDOSTOT, or MLDOSTXT. |
Perm |
| MLDOSFRM |
Dose Form |
Char |
Variable Qualifier |
Dosage form for MLTRT. Example: "BAR, CHEWABLE". |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
Perm |
| 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 VISIT. Should be an integer. |
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 meal started. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the start date/time of the meal. |
Perm |
| MLDTC |
Date/Time of Collection |
Char |
Timing |
Collection date and time of the meal represented in ISO 8601
character format. |
Perm |
| MLSTDTC |
Start Date/Time of Meal |
Char |
Timing |
Start date/time of the meal represented in ISO 8601
character format. |
Perm |
| MLENDTC |
End Date/Time of Meal |
Char |
Timing |
End date/time of the meal represented in ISO 8601 character
format. |
Perm |
| MLDY |
Study Day of Visit/Collection/Exam |
Num |
Timing |
Actual study day of the visit/collection expressed in
integer days relative to the sponsor-defined RFSTDTC in
Demographics. |
Perm |
| MLSTDY |
Study Day of Start of Meal |
Num |
Timing |
Actual study day of start of the meal expressed in integer
days relative to sponsor-defined RFSTDTC in Demographics. |
Perm |
| MLENDY |
Study Day of End of Meal |
Num |
Timing |
Actual study day of end of the meal expressed in integer
days relative to the sponsor-defined RFSTDTC in Demographics. |
Perm |
| MLDUR |
Duration of Meal |
Char |
Timing |
Collected duration of the meal represented in ISO 8601
character format. Used only if collected on the CRF and not derived.
|
Perm |
| MLTPT |
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. See MLTPTNUM
and MLTPTREF. |
Perm |
| MLTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numeric version of planned time point used in sorting. |
Perm |
| MLELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
Planned Elapsed time (in ISO 8601) relative to the planned
fixed reference (MLTPTREF). This variable is useful when there are
repetitive measures. Not a clock time or a date/time variable.
Represented as an ISO 8601 duration. |
Perm |
| MLTPTREF |
Time Point Reference |
Char |
Timing |
Description of the fixed reference point referred to by
MLELTM, MLTPTNUM, and MLTPT. |
Perm |
| MLRFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time for a fixed reference time point defined by
MLTPTREF in ISO 8601 character format. |
Perm |
| MIDS |
Disease Milestone Instance Name |
Char |
Timing |
The name of a specific instance of a Disease Milestone Type
(MIDSTYPE) described in the Trial Disease Milestones dataset. This
should be unique within a subject. Used only in conjunction with
RELMIDS and MIDSDTC. |
Perm |
| RELMIDS |
Temporal Relation to Milestone Instance |
Char |
Timing |
The temporal relationship of the observation to the Disease
Milestone Instance Name in MIDS. Examples: "IMMEDIATELY BEFORE", "AT
TIME OF", "AFTER". |
Perm |
| MIDSDTC |
Disease Milestone Instance Date/Time |
Char |
Timing |
The start date/time of the Disease Milestone Instance Name
in MIDS, in ISO 8601 format. |
Perm |