| STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
DE |
Identifier |
Two-character abbreviation for the domain. |
Req |
| USUBJID |
Unique Subject Identifier |
Char |
|
Identifier |
Exp |
| SPDEVID |
Sponsor Device Identifier |
Char |
|
Identifier |
Sponsor-defined identifier for the device. |
Req |
| DESEQ |
Device Events Sequence Number |
Num |
|
Identifier |
Sequence Number given to ensure uniqueness of device records
within subject records within a domain. |
Req |
| DESPID |
Sponsor-Defined Identifier |
Char |
|
Identifier |
Sponsor-defined reference number. |
Perm |
| DETERM |
Reported Term for Device Event |
Char |
|
Topic |
Verbatim name of the observed event. |
Req |
| DEMODIFY |
Modified Device Event Name |
Char |
|
Synonym Qualifier |
The modified text for DETERM |
Perm |
| DEDECOD |
Device Events Dictionary-Derived Term |
Char |
* FDA's Device Problem Codes |
Synonym Qualifier |
Dictionary-derived form of the event described in DETERM. |
Req |
| DECAT |
Category of Device Event |
Char |
* |
Grouping Qualifier |
Used to define a categorization level for events. |
Perm |
| DESCAT |
Subcategory of Device Event |
Char |
* |
Grouping Qualifier |
Used to define a further category level for events. |
Perm |
| DEPRESP |
Pre-Specified Device Event |
Char |
( NY ) |
Record Qualifier |
Used to indicate whether (Y/null) information about a
specific event was solicited on the CRF. |
Perm |
| DEOCCUR |
Device Event |
Char |
( NY ) |
Record |
When information about specific events is |
Perm |
| |
Occurrence |
|
|
Qualifier |
solicited, DEOCCUR is used to indicate whether or not (Y/N)
a particular pre-specified event occurred. |
|
| DESTAT |
Device Event Collection Status |
Char |
(ND) |
Record Qualifier |
The status indicates that the pre-specified question was not
answered. |
Perm |
| DEREASND |
Reason Device Event Not Collected |
Char |
|
|
Reason DESTAT was "not done" |
Perm |
| DESEV |
Device Event Severity |
Char |
* |
|
Severity of Event |
Perm |
| DEACNDEV |
Action Taken with Device |
Char |
* |
|
Describes Action Taken with respect to the device |
Perm |
| VISITNUM |
Visit Number |
Num |
|
Timing |
Clinical encounter number. |
Exp |
| VISIT |
Visit Name |
Char |
|
Timing |
Protocol-defined description of clinical encounter. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
|
Timing |
Planned study day of the visit based upon RFSTDTC in
Demographics. |
Perm |
| DEDTC |
Date of Device Event Data Collection |
Char |
ISO 8601 |
Timing |
Date the device event information was collected. |
Perm |
| DESTDTC |
Start Date/Time of Device Event |
Char |
ISO 8601 |
Timing |
Start date/time of the device event. |
Perm |
| DEENDTC |
End Date/Time of Device Event |
Char |
ISO 8601 |
Timing |
End date/time of the device event. |
Perm |
| DEDY |
Study Day of Device Event Data Collection |
Num |
|
Timing |
Study day of Device Event observation, measured as integer
days. |
Perm |
| DESTDY |
Study Day of Device Event Start Date/Time |
Num |
|
Timing |
Study day of start of Device Event, measured as integer
days. |
Perm |
| DEENDY |
Study Day of Device Event End Date/Time |
Num |
|
Timing |
Study day of end of Device Event, measured as integer days. |
Perm |