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The ClinPlus® Software Solutions Suite for Clinical Trials provides premium tools required by pharmaceutical companies, contract research organizations (CROs), biotechs, and medical device manufacturers to expedite clinical trials and meet the strict data formatting requirements of the FDA and other global regulatory agencies.

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SAS Clinical Study Report Tip from DZS/ClinPlus

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Question: We are running a Phase 2 clinical trial where we have unique groups being treated differently and we are struggling with how to program a report to have different footnotes based on the value of a paging variable.  Is it possible to have different footnotes for male patients vs. female patients? What would the eventual tables look like?

Answer: Yes, page-by variable dependant footnotes (and titles) are possible, and can be easily accomplished using ClinPlus Report, please see the SAS code below:

/**********************************************************************************

** Creating a report with conditional footnote lines.

** Conditional Footnote lines: The footnotes are different by pages

**                              according to a page-by variable.

**

** Example:

** The report below is paged by the variable SEX.

** For 'Female' there are 3 footnote lines,

** for 'Male' there are only two footnote lines in the report.

**

** The conditional footnote lines added to the input data set (See second data step)

** as variables ft1, ft2 and ft3.

** In the %DZSTABLE macro call the titles parameter contains the paging variable

** !SEX and the footnote parameter contains the !FT1, !FT2 and !FT3 variables.

**

** Resulting report will print the appropriate footnote limes by pages.

***********************************************************************************/

 

**Invoke Report Engine********************************************;

%inc "D:\dzstable\SAS920\ver710\dzsload.sas";

 

**RTF Style location*********************************************;

libname rtflib "d:\temp";

 

**Create input data set*******************************************;

proc format;

  value sex 1='Female' 2='Male';

  value group 1='Drug 1 ' 2='Drug 2' 3='Placebo';

  value race 1='White' 2='Black' 3='Oriental' 4='Hispanic';

run;

 

data test;

  group=1;

  pat=1; age=35.5; sex=1; race=1; weight=89.7; output;

  pat=2; age=45.2; sex=1; race=2; weight=156.25; output;

  pat=3; age=25; sex=1; race=1; weight=178.5; output;

  pat=4; age=19; sex=2; race=4; weight=92.3; output;

  group=2;

  pat=31; age=26.25; sex=2; race=1; weight=79.6; output;

  pat=32; age=63; sex=2; race=3; weight=119.9; output;

  pat=33; age=45; sex=1; race=2; weight=125.45; output;

  pat=34; age=27.7; sex=2; race=2; weight=89.12; output;

  pat=35; age=37.7; sex=1; race=4; weight=131.56; output;

  group=3;

  pat=31; age=26.25; sex=2; race=1; weight=79.6; output;

  pat=32; age=63; sex=2; race=3; weight=119.9; output;

  pat=33; age=45; sex=1; race=2; weight=125.45; output;

  pat=34; age=27.7; sex=2; race=2; weight=89.12; output;

  pat=35; age=37.7; sex=1; race=4; weight=131.56; output;

  format group group. race race. sex sex.;

run;

 

**Add footnotes to input data set.**;

data test; length ft1 ft2 ft3 $100; set test;

  if sex=1 then do;

    ft1="First footline for Female";

    ft2="Second footline for Female";

    ft3="Third footline for Female";

  end;

  else if sex=2 then do;

    ft1="First footline for Male";

    ft2="Second footline for Male";

    ft3="";

  end;

run;

 

**Create report (with RTF output)*********************;

%dzstable(titles=@_indent Test Conditional footnotes\@_indent !syspage\Demographics Summary report\!sex\@,

          display=n median mean nextto std freq nextto ppercentp ,

          across=group,

          down= over ,

          skipline=,

          data=test,

          pgnumfmt=PAGE: #n of #m,

          spacing=1,

          ll=120, pl=47,

                  rtf=d:\temp\TestFootnote.rtf,

                  rtfStyle=rtflib\test,

                  multplyr=15,

          footnote=%str(@_indent Common Footnote Line\@_indent !ft1\@_indent !ft2\@_indent !ft3),

          options=snugfoot onlyhorz solidline blankskip center nodate nonumber);

conditional footnotes

 

 

 

 

 

 

 

 

footnote by page variable

Need to produce "SAS-based" Tables and Listings in a hurry?

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SAS Programmer

Avoiding that huge mess when your lead SAS programmer gives notice...

Statistical Programmers are varied in their approach on how they execute their craft.  Each programmer is unique in how they get to their end result.  This varied approach can be challenging when you want to replicate what was done or pass on the knowledge to other programmers.  Worst case scenario, your lead programmer gives notice and you are left with deciphering their code. 

The impending disaster that could result when your lead programmer gives notice and leaves, with the intimate knowledge of the work in progress can be avoided if your team uses ClinPlus Report® for generating reports.  Although ClinPlus Report is not a library of reports, it does produce reports in an extremely standardized, template-based manner. 

The system is not only capable of developing standardized and one-off reports, but it is also excellent for organizing reports for a workgroup. Corporate-level, standard template libraries are able to be created and maintained so that project and study-level templates can be easily derived by statistical programmers.  All of the templates are written using a common logical approach, thereby eliminating confusion amongst programmers and providing a clear path to understanding how templates are created for new programmers. 

Additionally the system includes additional features such as a title and footnote library layered in levels for easy maintenance, RTF output generation in format designed to please the pickiest of medical writers and the ability to extend to a listing, patient profile and data base QC tool for Data Managers.

The tables and listings generated out of ClinPlus Report are produced using an automatically generated SAS data null program that  provides the flexibility the Life Sciences  industry demands, without compromise.

So, when left in a lurch by key programmers who are moving on and your deadline is staying put, you can rest easy that new programmers or experienced DZS programmers can pick up the ball and run without delay using ClinPlus Report.  At this late stage in the game, can you afford any less?

For more information on ClinPlus Report and a FREE download of tables and listings examples please go to:

http://www.clinplus.com/report-landing-clinplus-report-tables-listings/?utm_campaign=Report%20&utm_source=DZS%20Blog

 

 

 

 

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