Installation Instructions
Perform the following steps to install the %cdisc macro to your SAS System.

• Download the following SAS programs and transport file to your machine.

  cdisc.sas - SAS program macro

  cdisc.xpt - SAS catalog in transport format

  Note the path location where you have saved it to.
   

• Edit the cdisc.sas program by updating libname PGMLIB and filename OUTFILE to reflect your path noted above.
• Submit the following SAS program with an updated path:
  
  %include "c:\mypath\cdisc.sas";
  %install;
   
• You can now run this on any your machine by including the macro or add the noted path to your SASAUTOS path.

NOTE: This has been tested on Windows XP and Solaris 5.9.

Reference Guide

%cdisc (datlib = data library, 
        datname = dataset name);

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:

1. Required Fields: (2.4.5) Required identifier variables including: DOMAIN, USUBJID, STUDYID and --SEQ.
2. Subject Variable: (3.5.1.2.8) For variable names, labels and comments, use the word "Subject" when referring to "patients" or "healthy volunteer".
3. Variable Length: (3.5.1.2.6) Variable names are limited to 8 characters with labels up to 40 characters.
4. 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.
5. Date Time Format: (3.5.1.4.19) Use yymmdd10. but yymmdd8. is acceptable.
6. Study Day Variable: (3.5.1.4.22) Study day variable has the name ---DY.
7. Variable Names: (3.5.2) If any variable names used matches CDISC variables, the associated label has to match.
8. Variable Label: (3.5.2) If any variable labels match that of CDISC labels, the associated variable has to match.
9. Variable Type: (3.5.2) If any variables match that of CDISC variables, the associated type has to match.
10. Dataset Names: (3.5.2) If any of the dataset names match CDISC, the associated data label has to match.
11. Dataset Labels: (3.5.2) If any of the dataset label match CDISC, the associated dataset name  has to match.
12. Abbreviations: (3.5.2) The following abbreviations are suggested for variable names and data sets.
    
     

    Acronym	Descriptive Text
    ae	Adverse Events
    bl	Baseline
    brth	Birth
    cat	Category
    clas	Class
    cd	Code
    cm	Concomitant Medications
    dt	Date
    dy	Day
    dm	Demographics
    ds	Disposition
    dos	Dose
    dur	Duration
    eg	ECG
    eval	Evaluator
    ex	Exposure
    fl	Flag
    frm	Form
    frq	Frequency
    gr	Grade
    hosp	Hospital
    id	Identifier
    ie	Inclusion/Exclusion Exceptions
    ind	Indication
    ind	Indicator
    inv	Investigator
    lb	Labs
    loc	Location
    lo	Lower
    mh	Medical History
    num	Number
    occur	Occurrence
    ord	Order
    or	Original
    or	Original
    pe	Physical Exam
    pt	Point
    pos	Position
    reas	Reason
    ref	Reference
    rgm	Regimen
    r	Related
    rel	Relationship
    rl	Rule
    seq	Sequence
    stat	Status
    scat	Subcategory
    subj	Subject
    sc	Subject Characteristics
    su	Substance Use
    txt	Text
    tm	Time
    tot	Total
    tox	Toxicity
    tran	Transition
    trt	Treatment
    ex	Treatment or Exposure
    u	Unique
    u	Units
    up	Unplanned
    hi	Upper
    val	Value
    var	Variable
    vs	Vital Signs

     

13. SEQ Values: (4.3.2.1) When the --SEQ variable is used, it must have unique values for each USUBJID within each domain.
14. Label Casing: For Dataset labels and variable labels, all non trivial words (more than three characters) must start with a capital letter with the rest of the characters lowercase.
15. Required Values: For required fields such as the ones specified in number 1, check to see if there are values.  If there are any missing, values, report the observation number where it is missing.
16. Similar Parenthesis:  For labels with matching values inside parenthesis such as (Yes/No) within the same dataset, it will check to see if the variables have the same type and length.  If not, it will report the differences.

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.  An HTML report will be generated documenting the findings.  The report name will be the same name as the current program with the (.html) file extension.

If the macro is called without any parameters, a dialog box will be opened to allow users to select the datasets to be evaluated.

Example

%cdisc (datlib=mylib, 
        datname=ae);

%cdisc (datlib=mylib, 
        datname=ae*);

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