Change from Baseline Disease Status
1.
Study Identifier
2.
Subject Identifier
3.
Visit
4.
Visit Number
(integer only)
5.
Visit Date
/
/
(mm/dd/yyyy)
6.
Assessment of Disease Status Change from Baseline
Much Worse
Worse
A Little Bit Worse
No Change
A Little Bit Better
Better
Much Better
7.
Comment on Post-Baseline Disease Status Assessment
CDISC domain ODM metadata