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Verify SAS datasets against
CDISC standards
%cdisc (datlib = data library,
datname = dataset name);
| Where |
Is Type... |
And represents... |
| datalib |
C
(200) |
Library name
reference the location where the dataset resides. |
| datname |
C
(200) |
Name
of the dataset to be verified. Wild cards can be specified such
as ae*. |
Details
This tool verifies SAS datasets against CDISC submission data
domain models version 3.0 as specified at: http://www.cdisc.org/pdf/V3CRTStandardV1_2.pdf.
It is intended to catch deviations of standards including the
following:
- Required Fields: (2.4.5)
Required identifier variables including: DOMAIN, USUBJID, STUDYID and --SEQ.
- Subject Variable: (3.5.1.2.8)
For variable names, labels and comments, use the word
"Subject" when referring to "patients" or
"healthy volunteer".
- Variable Length:
(3.5.1.2.6) Variable names are limited to 8 characters with labels up to
40 characters.
- Yes/No: (3.5.1.3.18) Variables where the response is Yes or No (Y/N) should normally be populated for both Yes and No responses.
- Date Time Format: (3.5.1.4.19)
Use yymmdd10. but yymmdd8. is acceptable.
- Study Day Variable:
(3.5.1.4.22) Study day variable has the name ---DY.
- Variable Names: (3.5.2) If
any variable names used matches CDISC variables, the associated label
has to match.
- Variable Label: (3.5.2) If
any variable labels match that of CDISC labels, the associated variable
has to match.
- Variable Type: (3.5.2) If
any variables match that of CDISC variables, the associated type has to
match.
- Dataset Names: (3.5.2) If
any of the dataset names match CDISC, the associated data label has to
match.
- Dataset Labels: (3.5.2) If
any of the dataset label match CDISC, the associated dataset name
has to match.
- Abbreviations: (3.5.2) The
following abbreviations are suggested for variable names and data sets.
- DM Demographics
- CM Concomitant Medications
- EX Exposure
- AE Adverse Events
- DS Disposition
- MH Medical History
- EG ECG
- IE Inclusion/Exclusion Exceptions
- LB Labs
- PE Physical Exam
- SC Subject Characteristics
- SU Substance Use
- VS Vital Signs
- SEQ Values: (4.3.2.1) When the --SEQ variable is used, it must have unique values for each USUBJID within each domain.
The findings from the above
evaluation will be stored in a dataset named WORK.CDISC. Each
test case will be identified by a column named "case" which
corresponds to each item listed above.
Example
%cdisc (datlib=mylib,
datname=ae);
%cdisc (datlib=mylib,
datname=ae*);
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