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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist, or Format
Role
CDISC Notes
Core
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.