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CO Domain Challenges For Statistical Programmer

The CO domain is used to capture unstructured free text comments and allows adding variables to handle text exceeding 200 characters. When text is longer than 200 characters in the CO domain, additional variables COVAL1-COVALn will be derived to store the text in sections of up to 200 characters each without truncating words. The CO domain is structured similarly to the SUPP-- dataset and uses keys to identify related comments and their source as related to a specific domain, parent record, or neither.

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24 views2 pages

CO Domain Challenges For Statistical Programmer

The CO domain is used to capture unstructured free text comments and allows adding variables to handle text exceeding 200 characters. When text is longer than 200 characters in the CO domain, additional variables COVAL1-COVALn will be derived to store the text in sections of up to 200 characters each without truncating words. The CO domain is structured similarly to the SUPP-- dataset and uses keys to identify related comments and their source as related to a specific domain, parent record, or neither.

Uploaded by

shahanish062
Copyright
© © All Rights Reserved
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Download as DOCX, PDF, TXT or read online on Scribd
Download as docx, pdf, or txt
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CO(Comments)Dataset: Challenges for Statistical

Programmer
Abstract:
In SDTM domains, all character variables are limited to a maximum of 200 characters due to FDA
requiring datasets in SAS v5 transport format. Text more than 200 characters long should be stored
as a record in the SUPP-dataset. But Comments (CO) domains, is used to capture unstructured free
text comments and allowed to add variables for the purpose of handling text exceeding 200
characters sections. To improve readability the text should be split between words not just broken
the text into 200-character - i.e., when text is longer than 200 characters in CO domain, additional
variables COVAL1-COVALn will be derived. The first 200 characters of the comment will be in COVAL,
the next 200 in COVAL1, and additional text stored as needed to COVALn. This explains how the
values of long text variable into a set of smaller variables without truncating an intact word and
automatically generate COVALn in the CO domain. The Comments special-purpose domain is
structured similarly to the Supplemental Qualifiers (SUPP--) dataset, in that it uses the same set of
keys (STUDYID, RDOMAIN, USUBJID, IDVAR, and IDVARVAL) to identify related records. The
comments datasets accommodate three sources of comments a) Those unrelated to a specific
domain or parent record(s), in which case the values of the variables RDOMAIN, IDVAR and
IDVARVAL are null. CODTC should be populated if captured b) Those related to a domain but not to
specific parent record(s), in which case the value of the variable RDOMAIN is set to the DOMAIN
code of the parent domain and the variables IDVAR and IDVARVAL are null. CODTC should be
populated if captured c) Those related to a specific parent record or group of parent records, in
which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s) and
the variables IDVAR and IDVARVAL are populated with the key variable name and value of the parent
record(s). CODTC should be null because the timing of the parent record(s) is inherited by the
comment record.

Collect the ingfor

Finalize the contents of the paper

Abstract will not be part of ppt

Difference between Datasets and Domain

What is CO and why it is req.

How it is useful?
The CO domain is a special-purpose domain that provides a solution for submitting free-text
comments related to data in one or more SDTM domains. COVAL is the variable in CO to contain the
text of comments. When text is longer than 200 characters, additional columns COVAL1-COVALn will
be generated. . The Comments special-purpose domain is structured similarly to the Supplemental
Qualifiers (SUPP--) dataset in that it uses the same set of keys (STUDYID, RDOMAIN, USUBJID, IDVAR,
and IDVARVAL) to identify related records. The comments datasets accommodate three sources of
comments a) Those unrelated to a specific domain or parent record(s), in which case the values of
the variables RDOMAIN, IDVAR and IDVARVAL are null. CODTC should be populated if captured b)
Those related to a domain but not to specific parent record(s), in which case the value of the variable
RDOMAIN is set to the DOMAIN code of the parent domain and the variables IDVAR and IDVARVAL
are null. CODTC should be populated if captured c) Those related to a specific parent record or group
of parent records, in which case the value of the variable RDOMAIN is set to the DOMAIN code of the
parent record(s) and the variables IDVAR and IDVARVAL are populated with the key variable name
and value of the parent record(s). CODTC should be null because the timing of the parent record(s) is
inherited by the comment record.

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