Clinical Studio users are responsible for creating their own randomization schedules. This is usually done by a biostatistician supporting the study. Randomization files dictate how Clinical Studio will distribute randomization allocations over sites or the entire study, depending on how the randomization is defined. Read more here about defining the randomization.


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 file to be imported into Clinical Studio.

Column

Type

Description

site_no
(Optional)

Integer

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.

sub_no

Integer

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.

stratification 1

Integer

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 male and 25 female, 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.

stratification 2,3,4,...

Integer

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.

allocation

Integer

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 a 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)

String

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.


NEW OPTION:

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.

  

To upload a randomization file, select "Import Randomization File..." option from the Study Menu as shown in the figure below.




Import Randomization File… link

The following illustration will appear when then "Import Randomization Link..." is selected.





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.   If the randomization file has errors, the errors will be displayed on the screen for the user to review.  The following table is a simple randomization file for a single stratified randomization.

Site

(Optional)

Patient

Gender

(Optional)

Randomization

Subject Profile ID

(Optional)

1

1

1

0

01-01

1

2

1

1

01-02

1

3

1

3

01-03

1

4

0

2

01-04

1

5

0

1

01-05

1

6

0

2

01-06

2

1

1

0

02-01

2

2

1

3

02-02

2

3

1

1

02-03

2

4

0

2

02-04

2

5

0

3

02-05

2

6

0

1

02-06


The above table has 2 sites, 6 subjects per site, 2 stratified genders and is a 4-arm randomization. It also returns the Subject Profile ID to replace the system-generated ID. 

Please note, the Site number is not the actual number of a site. It is merely a sequential number up to the number of sites that are in the study. Subjects will get allocated in order of enrollment. In other words, regardless of which site enrolls first, that will be Site 1 group. From that point on, all subjects at that site will be part of "Site 1" group.



Patient

Randomization

1

0

2

1

3

1

4

0

5

0

6

1

7

0

8

1

9

1

10

0


The above table has 10 subjects and is a 2-arm randomization. It is a 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.