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. |
Req |
DTSEQ |
Sequence Number |
Num |
|
Identifier |
Sequence Number given to ensure uniqueness of device records
within subject records (if applicable) within a domain. |
Req |
DTTERM |
Reported Term for the Tracking Event |
Char |
* |
Topic |
Verbatim or preprinted term for the activity that occurs. |
Req |
DTMODIFY |
Modified Reported Term |
Char |
|
Synonym Qualifier |
Modified term entered to allow mapping of verbatim term to
dictionary term |
Perm |
DTDECOD |
Standardized Tracking Term |
Char |
* |
Synonym Qualifier |
Dictionary-derived text description of DTTERM or DTMODIFY. |
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. |
Req |
DTPRTYID |
Responsible Party Identifier |
Char |
|
Variable Qualifier |
An identifier for the responsible group/role (e.g. site,
subject). |
Exp |
DTCAT |
Category for Device Tracking Event |
Char |
* |
Grouping Qualifier |
Define a categorization level for a group of related
records. |
Exp |
DTSCAT |
Subcategory for Device Tracking Event |
Char |
|
Grouping Qualifier |
Defines a further categorization level for a group of
related conditions or events. |
Perm |
DTDTC |
Date/Time of Device Tracking Event Collection |
Char |
ISO 8601 |
Timing |
Date/Time of the tracking event information was collected. |
Perm |
DTSTDTC |
Start Date/Time of Device Tracking Event |
Char |
ISO 8601 |
Timing |
Start date/time of tracking event. |
Req |