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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

The Essentials 2010: What You Need in a CTMS Now!

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Trial management

Pick any sector, any endeavor, any corner of the globe you like: 2010 promises to be a challenging year.

Although somewhat insulated from economic downturns due to the long development cycles of its products, pharma is certainly not immune to the malaise gripping the globe.

Certainly, one thing seemingly unstifled by the global downturn is the increasing complexity of managing clinical trials and data associated with clinical research.
As the number of sites on trials increases, so too, do the number of patients/subjects in the trials; getting sites initiated has become a process unto itself; paying investigators, managing contractor invoices, patient/subject cohort management, all grow more complicated every day.

To keep up, you need technology that keeps up: fast, flexible, web-based apps that can track subject visits, monitor visits, documents, payments, and inventories; something with good reporting options, easy-to-use metrics, and tools that automate wherever possible to produce cross-trial and even cross-study consistency.

These are some of the essentials we think the well-prepared clinical trial manager will look for in a CTMS this year:

• To make timely decisions, you need on-demand access to current trial data.
• The faster you can deploy studies, the faster you can conclude them. Look for flexibility to match your business processes and scalability to grow in your CTMS.
• Automate. Wherever, whenever you can. Loose the spreadsheets
• Quick access to study and regulatory guidance documentation helps quickly clear up any questions lost in translation from raw data to results during clinical trials
• Facilitate communication between teams. It's one of the hidden traps slowing organizations down more than they realize. Give your teams access to global contact databases and document repositories.
• The more closely you can manage investigator payments, the more control you have over budgets and how they're spent.
• Ensure 21 CFR Part 11 compliant, role-based security. Anything less is an invitation to disaster.
• Give managers and system administrators the tools they need to control access to features and data on a project by project basis.

If you'd like to see what a CTMS system can do for you, please visit our site and learn more even arrange a short demo.

http://www.clinplus.com/products/clinical-trial-management-software/ctms-demo/?utm_campaign=What%20you%20need%20in%20a%20CTMS-%202010&utm_medium=blog%20post&utm_source=CTMS%20Blog%20article&utm_term=CTMS

 


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