|
SDTMIG 3.3 |
SM |
1 |
STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
|
SDTMIG 3.3 |
SM |
2 |
DOMAIN |
Domain |
Char |
SM |
Identifier |
Two-character abbreviation for the domain. |
Req |
|
SDTMIG 3.3 |
SM |
3 |
USUBJID |
Unique Subject Identifier |
Char |
|
Identifier |
Identifier used to uniquely identify a subject across all studies. |
Req |
|
SDTMIG 3.3 |
SM |
4 |
SMSEQ |
Sequence Number |
Num |
|
Identifier |
Sequence number to ensure uniqueness of subject records. Should be assigned to be consistent chronological order. |
Req |
|
SDTMIG 3.3 |
SM |
5 |
MIDS |
Disease Milestone Instance Name |
Char |
|
Topic |
Name of the specific Disease Milestone. For types of Disease Milestone that can occur multiple times, the name will end with a sequence number. Example: "HYPO1". |
Req |
|
SDTMIG 3.3 |
SM |
6 |
MIDSTYPE |
Disease Milestone Type |
Char |
|
Record Qualifier |
The type of Disease Milestone. Example: "HYPOGLYCEMIC EVENT". |
Req |
|
SDTMIG 3.3 |
SM |
7 |
SMSTDTC |
Start Date/Time of Milestone |
Char |
ISO 8601 |
Timing |
State date/time of Milestone Instance, if Milestone is an intervention or event, or date of Milestone if Milestone is a finding. |
Exp |
|
SDTMIG 3.3 |
SM |
8 |
SMENDTC |
End Date/Time of Milestone |
Char |
ISO 8601 |
Timing |
End date/time of Disease Milestone Instance. |
Exp |
|
SDTMIG 3.3 |
SM |
9 |
SMSTDY |
Study Day of Start of Milestone |
Num |
|
Timing |
Study day of start of Disease Milestone Instance, relative to the sponsor-defined RFSTDTC. |
Exp |
|
SDTMIG 3.3 |
SM |
10 |
SMENDY |
Study Day of End of Milestone |
Num |
|
Timing |
Study day of end of Disease Milestone Instance, relative to the sponsor-defined RFSTDTC. |
Exp |