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Metadataspec

Num

Fragment

CDISC Notes

1

BL

Baseline. As described below, the The position of this fragment within the variable name is dependent on the purpose of the variable.

Not to be used to support more than 1 baseline definition for AVAL in BDS datasets. See paragraph immediately following this table.

2

CHG

Change. As described below, the position of this fragment within the variable name is dependent on the purpose of the variable.

Not to be used to support change from more than one baseline for AVAL in BDS datasets. See paragraph immediately following this table.

3

FU

Follow-up. As described below, the position of this fragment within the variable name is dependent on the purpose of the variable.

4

OT

On treatment. As described below, the position of this fragment within the variable name is dependent on the purpose of the variable.

5

RU

Run-in. As described below, the position of this fragment within the variable name is dependent on the purpose of the variable.

6

SC

Screening. As described below, the position of this fragment within the variable name is dependent on the purpose of the variable.

7

TA

Taper. As described below, the position of this fragment within the variable name is dependent on the purpose of the variable.

8

TI

Titer. As described below, the position of this fragment within the variable name is dependent on the purpose of the variable.

9

U

Units. The position of this fragment is at the end of the variable, as a suffix.

To identify the units for a variable, a separate variable can be created, using the name of the original variable with a "U" suffix added. To keep within the 8-character variable name length limit, some truncation may be necessary prior to appending the U. In situations where the units do not vary within the ADaM dataset, it may be preferable to simply include the units in the variable's label and metadata. The approach taken will be determined by the producer, based on the requirements of the analysis and review of the dataset. Note that there is no separate units variable for BDS variables PARAM or AVAL, since the units of AVAL will be included in the value of PARAM.

10

WA

Washout. As described below, the position of this fragment within the variable name is dependent on the purpose of the variable.

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