| STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
DI |
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 |
| DISEQ |
Sequence Number |
Num |
|
Identifier |
Sequence number given to ensure uniqueness within a
parameter within a device (SPDEVID) within dataset.If there is only
one value for DIPARMCD for each value of SPDEVID, then DISEQ will be
1 for all records. DISEQ must be a valid number. |
Exp |
| DIPARMCD |
Device Identifier Element Short Name |
Char |
* |
Topic |
Short name of the identifier characteristic of the device
(e.g., "SERIAL", "MODEL").A record with DIPARMCD = "DEVTYPE" should
be included (see below). |
Req |
| DIPARM |
Device Identifier Element Name |
Char |
* |
Synonym Qualifier |
Name of the identifier characteristic of the
device.Examples: Serial Number, Model. A record with DIPARM =
"DEVTYPE" should be included (see below). |
Req |
| DIVAL |
Device Identifier Element Value |
Char |
* |
Result Qualifier |
Value for the parameter. Value for the parameter. When
DIPARMCD=DEVTYPE it should use controlled terminology defined by FDA
in their Preferred Term codelist. FDA has stated a preference for
the Global Medical Device Nomenclature (GMDN), but as of the date of
this publication, the GMDN is not freely available to the public. In
its Unique Device Identification rule , FDA indicated that
GMDN will not be required unless it is available to the public at no
cost. There is a lookup tool on the FDA website to map GMDN codes to
FDA PT codes. |
Req |