Overview
The CDISC SDTM data structure combines all comments into a separate
dataset. It is common for clinical data to have comments stored
along with the data in which it is collected. It is therefore a
common task to transform all the data contains comments into a separate
SDTM data structure. This tool automates this process by helping the
user identify and move comment fields into the specified CO dataset.
Comment
Options
The comment screen allows you to select all the options to instruct
CDISC builder to transform the selected data to the designated CO dataset.
The data flow is shown here.
Source Data
with Comments |
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CDISC Builder
Comment |
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CDISC
Comment (CO)
Data |
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The options available for
selecting data and options for CDISC comment transformation:
- Source Data - This is the
location of the dataset that is going to have the CDISC guidelines
verification check.
- Data Sets - The selected dataset
that is going to be verified.
- Preview - A print out of the
first 100 observation of the data
- Related Domain - The CDISC
related domain which the comment is associated with.
- Study Identifier - The name of
the study or the protocol number
- Comment Variable - The
variable(s) that contain the comments
- Date Variable - A date variable
associated with the comment
- Identification Variable - A
unique identifier such as a sequence number or date that uniquely
identifies the comment if there are multiple.
- Unique Subject ID Variable -
The subject ID variable
- Output - The output dataset
that which is usually CO
- Base Code - An optional SAS
base code that can be generated used to create the comment
transformation.
- Save Code - The code saved in
this location will contain a macro call capturing all the options that
has been selected. This can therefore be executed independent from
this interface as a SAS program.
- Find Comment - This option
searches through all existing datasets in the specified library for
possible comment fields.
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Only one dataset
can be selected at a time to have comment applied. This is due to
the fact that the identifying variable usually is different among each
dataset and therefore has to be selected individually. |
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