TrialKit users are responsible for creating their own randomization schedules. This is usually done by a biostatistician supporting the study. Randomization files dictate how TrialKit will distribute randomization allocations over sites or the entire study, depending on how the randomization is defined.
This section will explain the exact file format necessary to import a randomization file. The file needs to be in a comma-separated (.csv) file format.
The following figure displays the file layout of the file to be imported into TrialKit.
The site number. This will repeat for every allocation slot for a given site. NOTE: When using central randomization, this column should be omitted from the Randomization Table.
The subject number within the current site. This will be marked sequentially starting at 1 and ending at the last subject number. It will restart for each new site in the table.
For each level of stratification, enter the coded stratification. For example, if 1= Male and 2= Female, then a series of 1’s and 2’s would fill this column for each subject for each site. The codes do not have to be in order but is preferred to have the codes in order. For example, if the user is allocating 50 randomization slots per site, 25 males and 25 females, then the first 25 rows should be male while the next 25 rows should be female.
Each stratification level will get an additional column. If you are stratifying by gender and BMI group, then you would have two columns. Obviously, the more stratification levels you have, the more complex the randomization file.
See above, additional stratification fields will have their own columns, these extra columns will not be here if the user defines the randomization to have 1 layer of stratification.
This is the coded allocation that is returned to the randomize subject. When a randomized form is saved, the system will look for the first slot available and claim that randomization allocation and assign it to the subject. For example, if a user has randomization that is stratified by Gender and BMI; the system will look for the first gender and BMI group slot available within the subject’s site.
Subject profile ID (Optional)
If the user chooses to have the system return the subject profile id upon successful randomization, add a column here. This column should be omitted if the user is not returning the Subject Profile ID.
|Randomization ID (Optional)||String||If there is a separate randomization ID that needs to be collected and populated within the subject data (as described in the defined randomization), it can be identified here in the last column. The system then uses this ID to populate within a subject form as defined in the Form Builder.|
Note unless marked "(Optional)" the column MUST BE part of the import. :)
To upload a randomization file, select the "Import Randomization File..." option from the Study Menu.
Import Randomization File… link
A message will indicate if the file has been successfully imported or if there is a problem with one of the columns/rows.
Import Randomization Table Upload Example
The first step for importing a randomization file is to select which randomization definition the file to be uploaded should be associated with. Each randomization that is defined under the "Define Randomization" application will appear in the "Select Randomization To Import" drop-down at the top of the page.
Once the randomization is selected, click the Browse button to browse for the file location of the file that needs to be uploaded to the selected randomization. When the file is selected, upload the file to the server, by pressing the Upload Now button. Once uploaded, the randomization file will be available to the page.
The final step for importing a randomization file is to click the "Apply Randomization Table to Study". The system will upload the randomization file into the system and be ready to use it. If the randomization file has errors, the errors will be displayed on the screen for the user to review.
The above table has 10 subjects and is 2-arm randomization. It is central randomization that returns no subject profile id and does no stratification.
The system is flexible enough to handle either of the above randomization schemes. It can do anything in between as well.