Validating a CDISC SDTM SAS Data Set

CDISC Procedure Capabilities for Validating a CDISC SDTM SAS Data Set

PROC CDISC performs the following checks on domain content:

Verifies that all required variables are in the SAS data set.
Reports as an error any variables in the SAS data set that are not defined in the domain. Compared to CDISC SDS version 2.x, CDISC SDTM version 3.1 has more restrictions.
Reports a warning for any expected domain variables that are not in the SAS data set. Compared to CDISC SDS version 2.x, CDISC SDTM version 3.1 has more required domain variables.
Notes any permitted domain variables that are not in the SAS data set. PROC CDISC finds general omissions, but it is up to the site administrator to determine whether the omissions are appropriate.
Verifies that all domain variables are of the expected data type and proper length. For example, the validation reports if the SAS data set has SAS date and time variables that require ISO 8601 expansion.
Detects any domain variables that are assigned a controlled terminology specification by the domain and do not have a SAS format assigned to them. Only an assigned format is required.

PROC CDISC also performs the following checks on domain content on a per-observation basis:

Verifies that all required variable fields do not contain missing values.
Detects occurrences of expected variable fields that contain missing values.
Detects the conformance of all ISO 8601 assigned values, including date, time, datetime, duration, and interval types.
Notes correctness of YES or NO and YES, NO, or NULL responses.

With the exception of YES or NO and YES, NO, or NULL content, PROC CDISC does not validate the content of controlled terminology against a list of acceptable values.

Note: PROC CDISC does not do the following operations:

Automatically generate a V5 XPORT file from the SAS data set.
Create an XML document. PROC CDISC performs STDM 3.1 data content validation only.

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