How to easily convert clinical data to CDISC SDTM
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The SUPPQUAL datasets are created for each domain, e.g. SUPPDM. These datasets may
be transposed and merged back with the domain dataset, e.g. DM.
To distinguish SUPPQUAL variables from the Domain variables, the SUPPQUAL variables
are prefixed with ͚~͛ in the Domain definition.
Validate the mapping file ‘tmpmapping.xls’
Once the working version of the mapping file ͚tmpmapping.xls͛ is completely filled, the file has to
be checked for logical and syntactical errors by running the program, Validate_Mapping_File.sas,͛
before comforting the data to SDTM. This SAS program will check whether the tmpmapping.xls
A message will be displayed on the HTML page indicating the validation is successful. The
temporary mapping file will be renamed as ͚mapping.xls͛ and saved in the folder \CDISC
Express\Studies\my study\doc\Mapping file - validated version folder, and the previous validated
mapping file will be archived by adding the current date and time to the file name and stored in
the same folder.
If the validation fails, a list of error messages will be displayed in the HTML page
study\results\Mapping Validation. After reading the error message, user will correct errors in the
mapping file and then validate it again until all errors are cleared.
As errors may occur in several domains, to be more efficient and focused, it is possible to
comment out unnecessary domains by prefixing the sheet name with a dash in the
͚tmpmapping,xls͛ file as below. However, a domain should not be commented if certain
expressions require variables from other domains.
Below is the list of error handling codes that have been built into CDISC Express (\CDISC
Express\specs\Mapping validation\validation_err.xls) with five error categories (Figure 7).
Mapping file – Rules to check the mapping file structure
FORMAT Tab – Rules to check the data entered on the FORMAT tab.
CDISC mapping definition – Rules to check the mapping expression for the
SUPPQUAL domain – Rules for the SUPPQUAL domain
CO domain – Rules for the CO domain
This spreadsheet is used by the validation program to interpret error codes with variable names,
domain names, and/or type of errors. This list of error can be extended by adding new error
codes and definitions. Once a new definition is added, the macro ͚validatestudy.sas͛ should also
be updated to test the mapping file for the presence of these new errors.