Use this field to specify the name and complete path to a new folder containing the
S
tandard
D
ata
T
abulation
M
odel (
SDTM
) domain or
S
tandard for
E
xchange of
N
on-Clinical
D
ata (SEND) data for the combined study.
The Study Data Tabulation Model defines a standard format for reporting the results generated during clinical trials. Observations included in the SDTM must be reported, as collected, in clean,
raw
form. No derived values are reported in the SDTM. Observations are grouped by specific topic into individual SAS data sets, or
domains
. Refer to the
SDTM
website for additional details about the Standard Data Tabulation Model.
|
•
|
Adverse Events (
ae.sas7bdat
),
|
|
•
|
Concomitant Medications (
cm.sas7bdat
),
|
|
•
|
Demographics (
dm.sas7bdat
),
|
|
•
|
Disposition (
ds.sas7bdat
),
|
|
•
|
Electrocardiogram (
eg.sas7bdat
)
|
|
•
|
Exposure (
ex.sas7bdat
),
|
|
•
|
Laboratory Test Results (
lb.sas7bdat
),
|
|
•
|
Medical History (
mh.sas7bdat
), and
|
|
•
|
Vital Signs (
vs.sas7bdat
).
|
Note
: All SDTM domains must be placed in the same folder prior to analysis with JMP Clinical. This folder should be named
SDTM
.
The Standard for Exchange of Non-Clinical Data is an implementation of the Study Data Tabulation Model for studies that are not clinical in nature. Refer to the
SEND
website for additional details about the Standard for Exchange of Non-Clinical Data.
|
Click
and then navigate to the location of the data set.
|
|
|
Click
.
|