- Single asterisk(*) – Specifies there is no CT currently, sponsor defines their own CT while CDISC team may be developing one
Ex:
Variables in DM domain
Variable name
|
Label
|
Type
|
Controlled terminology
|
Role
|
ARMCD
|
Planned arm code
|
Char
|
*
|
Record qualifier
|
ARM
|
Description of planned arm
|
Char
|
*
|
Record qualifier
|
- List of controlled terms for the variable when the values are not maintained externally
- Hyperlinks provide values to external codelist specified in domain or appendix
Codelist short name
|
Description
|
SDTM variable
|
Comments
|
ACN
|
Action taken with study
treatment
|
--ACN
|
www.cancer.gov/cancertopics/terminology
resources/CDISC
|
AGEU
|
Age Unit
|
AGEU
|
www.cancer.gov/cancertopics/terminology
resources/CDISC
|
· ISO 8601 format to represent date/time variables
Ex:
Date/time
originally recorded
|
Precision
|
ISO 8601
format
|
March 15,2005
14:14:17
|
Complete
date/time
|
2005-03-15T14:14:17
|
March 15,2005
14:14
|
Unknown
seconds
|
2005-03-15T14:14
|
March 15,2005
|
Unknown hrs
and minutes
|
2005-03-15
|
March 15,2005
14:??:17
|
Unknown
minutes with known date, hrs and seconds
|
2005-03-15T14:-:17(missing
value represented by (-))
|
15,2005
|
Unknown month
|
2005---15
|
5:15 of some
unknown date
|
Unknown date
with known hour and minute
|
-----T05:15
|
·
To represent interval of uncertainity
Interval
of uncertainity
|
ISO8601
format
|
B/w
9:00 & 9:30 on morning of Nov 15,2005
|
|
Sometime
in first half of 2005
|
2005-01-01/2005-06-30
|
[S1]To separate
components in representation of date/time intervals
- ISO 8601 duration formats
Duration
is the quantity of time i.e equal to the
difference b/w time points(-STDTC &-ENDTC).Can be represented in the
following ways
PnYnMnDTnHnMnS
or PnW
|
Duration
originally recorded
|
ISO 8601
duration
|
|
2years
|
P2Y
|
|
10 weeks
|
P10W
|
|
3months 14days
|
P3M14D
|
|
3days
|
P3D
|
|
6months17days
3hrs
|
P6M17DT3H
|
|
14days7hours57minutes
|
P14DT7H57M
|
|
4 1/2weeks
|
P4.5W
|