Multiple dictionary setups connected to a single dictionary build database?
This is how you would setup a new thesaurus for that clinical study. You would create a new dictionary setup which points at the same dictionary build. This setup will essentially have an empty thesaurus to which you can now add new thesaurus entries to. Note that the thesaurus entries for this dictionary setup are stored in the SAME TABLE in the database as the thesaurus records for the other dictionary setup.
Dictionary Build MedDRA 14
• The build definition connects to a database
• In the database, one thesaurus table is created to store all thesaurus entries
• The one thesaurus table stores all thesaurus entries for all dictionary setups linked to the build
Here's a question we were asked regarding clinical trial coding that involved SAS programming.
Question? Can you code a software for covariate adaptive randomization? We are conducting a parallel double blind, placebo-controlled, 5-arm (1 control, 4 intervention) randomized study. We have a list of 225 subjects. For each subject we want the SAS program to put the subject in one of the five arms considering two covariates. The two covariates are: The Center where the patients are recruited (VA, UHS, and Center3), and the other is the Severity of Kidney Disease (Moderate, Severe). The random assignments using this method should prevent a skew of how the subjects get distributed in the arms (that is for example there should not be a large number of VA patients in one arm instead of being evenly distributed in all arms).
This can be done with covariate randomization models with normal distribution using Proc Lifetest, Proc GLM or Proc PHREG etc.
**Suppose there are 100 patients in 3 centers
classified by sever 1 or 2.**;
do i=1 to 100;
if i<33 then center=1;
else if i>32 and i<65 then center=2;
if i<5 or (i>17 and i<22) or (i>77 and i<92) then sever=1;
proc sort data=orig; by patNo;
**Randomly Assigning Subjects to Treatments we can use the PLAN procedureto design a completely randomized design to assign one of two treatments to each patients.**;
ods listing close;
proc plan seed=54321;
factors patNo=100 cell=1;
treatments trt=2 random;
proc sort data=rand(drop=cell); by patNo;
data randomized; merge orig(in=a) rand(in=b); by patNo;
You can find good articles and further explanations at the SAS support website when typing 'randomization' in the search field. But basically PROC PLAN and PROC FATEX SAS procedures can do it all.
Hope this was helpful! DZS Software Solutions
DZS/ClinPlus can also give you a hand producing the Statistical Analysis Tables of the trial results in the course of the trial. (Safety and Efficacy reports etc.).