| STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
DT |
Identifier |
Two-character abbreviation for the domain. |
Req |
| SPDEVID |
Sponsor Device Identifier |
Char |
|
Identifier |
Sponsor-defined identifier for the device.It must be unique
for each tracked unit of the device under study, and can be at
whatever level of granularity the device should be identified (e.g.,
model or serial number, combination of identifiers). |
Req |
| DTSEQ |
Sequence Number |
Num |
|
Identifier |
Sequence Number given to ensure uniqueness of device records
within subject records (if applicable) within a domain.May be any
valid number. Should be unique within each SPDEVID. |
Req |
| DTTERM |
Reported Term for the Tracking Event |
Char |
* |
Topic |
Verbatim or preprinted term for the activity that
occurs.Example: "Shipped", "Returned", "Installed", "Implanted",
"Explanted". |
Req |
| DTMODIFY |
Modified Reported Term |
Char |
|
Synonym Qualifier |
Modified term entered to allow mapping of verbatim term to
dictionary term.If DTTERM is modified to facilitate coding, then
DTMODIFY will contain the modified text. |
Perm |
| DTDECOD |
Standardized Tracking Term |
Char |
* |
Synonym Qualifier |
Dictionary-derived text description of DTTERM or DTMODIFY.If
an external controlled terminology is used, the name and version of
the dictionary used to map terms must be provided in a Define-XML
ExternalCodeList element. |
Perm |
| DTCAT |
Category for Device Tracking Event |
Char |
* |
Grouping Qualifier |
Defines a categorization level for a group of related
records.Examples: categorize by tracking event type (e.g.,
"DOMESTIC" vs. "INTERNATIONAL"). |
Exp |
| DTSCAT |
Subcategory for Device Tracking Event |
Char |
|
Grouping Qualifier |
Defines a further categorization level for a group of
related conditions or events. |
Perm |
| DTPARTY |
Party Responsible for the Device |
Char |
* |
Record Qualifier |
Person or organization accountable for the device at the
conclusion of the action specified in DTTERM.Describes the person or
organization that is accountable for the device defined in
DTTERM.For example, if DTTERM=SHIPPED, DTPARTY would contain the
transfer recipient (e.g., SITE). If DTTERM=IMPLANTED, DTPARTY would
contain SUBJECT. |
Req |
| DTPRTYID |
Responsible Party Identifier |
Char |
|
Variable Qualifier |
An identifier for the responsible group/role (e.g. site,
subject).The value of the responsible party identified in
DTPARTY.For example, if DTPARTY is SUBJECT, DTPRTYID would contain
the subject number. |
Exp |
| DTDTC |
Date/Time of Tracking Event Collection |
Char |
ISO 8601 |
Timing |
Date/Time the tracking event information was collected.Will
generally be the same as the date the tracking event started, but it
can differ. |
Perm |
| DTSTDTC |
Start Date/Time of Tracking Event |
Char |
ISO 8601 |
Timing |
Start date/time of tracking event.A tracking event (e.g.,
SHIPPED, RECEIVED) is usually a point in time, which is why only the
start date/time is included. If an event occurs over a longer
period, the stop date/time may be included from the SDTM model. |
Req |