|
SDTMIG 3.3 |
SV |
1 |
STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
|
SDTMIG 3.3 |
SV |
2 |
DOMAIN |
Domain Abbreviation |
Char |
SV |
Identifier |
Two-character abbreviation for the domain. |
Req |
|
SDTMIG 3.3 |
SV |
3 |
USUBJID |
Unique Subject Identifier |
Char |
|
Identifier |
Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. |
Req |
|
SDTMIG 3.3 |
SV |
4 |
VISITNUM |
Visit Number |
Num |
|
Topic |
1. Clinical encounter number. (Decimal numbering may be useful for inserting unplanned visits.) 2. Numeric version of VISIT, used for sorting. |
Req |
|
SDTMIG 3.3 |
SV |
5 |
VISIT |
Visit Name |
Char |
|
Synonym Qualifier |
1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter. |
Perm |
|
SDTMIG 3.3 |
SV |
6 |
VISITDY |
Planned Study Day of Visit |
Num |
|
Timing |
Planned study day of the start of the visit based upon RFSTDTC in Demographics. |
Perm |
|
SDTMIG 3.3 |
SV |
7 |
SVSTDTC |
Start Date/Time of Visit |
Char |
ISO 8601 |
Timing |
Start date/time for a Visit. |
Exp |
|
SDTMIG 3.3 |
SV |
8 |
SVENDTC |
End Date/Time of Visit |
Char |
ISO 8601 |
Timing |
End date/time of a Visit. |
Exp |
|
SDTMIG 3.3 |
SV |
9 |
SVSTDY |
Study Day of Start of Visit |
Num |
|
Timing |
Study day of start of visit relative to the sponsor-defined RFSTDTC. |
Perm |
|
SDTMIG 3.3 |
SV |
10 |
SVENDY |
Study Day of End of Visit |
Num |
|
Timing |
Study day of end of visit relative to the sponsor-defined RFSTDTC. |
Perm |
|
SDTMIG 3.3 |
SV |
11 |
SVUPDES |
Description of Unplanned Visit |
Char |
|
Synonym Qualifier |
Description of what happened to the subject during an unplanned visit. |
Perm |