If group of tests or an
individual test is ‘not done’ and the information is captured on CRF, it should
be indicated in corresponding dataset
On the other hand, if
there is no information for group of tests or an individual test whether it is
done/yes/no/not done or data on CRF is missing, a record must not be created to
indicate that data was not collected.
Examples for ‘TEST NOT
DONE’
1)FINDINGS:
For a given scheduled time point for lab data
collection urinalysis is checked “NOT DONE”:
LBTESTCD= “LBALL”
LBTEST= “Labs Data”
LBCAT= “URINALYSIS”
LBORRES=null
LBSTAT= “NOT DONE”
LBTESTCD
|
LBCAT
|
LBORRES
|
LBORRESU
|
LBSTRESC
|
LBSTRESN
|
LBSTRESU
|
LBSTAT
|
GLUC
|
CHEMISTRY
|
6.0
|
mg/dL
|
60.0
|
60.0
|
||
HCT
|
HEMATOLOGY
|
33.8
|
33.8
|
g/dL
|
|||
LBALL
|
URINALYSIS
|
NOT DONE
|
|||||
LBALL
|
NOT DONE
|