- Main menu - > Management - > Stratification;
- Click on ‘Add new stratification class’ or the icon in the column ‘Edit’ or ‘Remove’;
- Fill in the new desired information if necessary;
- Click on ‘Save’.
If you have the role of application manager, data manager or randomization manager in the module, then you can add, edit and remove stratification classes.
Go to https://myresearchmanager.com/NameCustomer . Log in with your username and password.
Attention: Does your organization use multiple modules within ResearchManager? In that case it could be that you first enter the module portal. Click on “EDC (Data management)”. Dependent on your settings it could be that you enter one of our other modules first. If you do not see “EDC (Data management)” in the top left corner of your screen, click on the logo you do see to get to the module portal. Then, click on “Data management” as well.
Step 1: Navigate towards ‘Stratification’
Now you see the starting page. Click at the top, in the menu bar, on ‘Management’. Then, click on ‘Stratification’ under the heading ‘Study settings’. Do you not see this option? Click on the page ‘Enabling stratification and randomization’ to read how you can add randomization to your study.
Step 2: Overview stratification classes
Now you find yourself on the page with stratification classes. You can see the reference, description, the maximum number of patients that is allowed to be in this class and the block size per class. Every stratification class will be linked to one or multiple conditions.
You can see these when you click on the arrow on the left of the class. You can also show the extra information of all classes at once by clicking on ‘Unfold all’. Click on ‘Fold all’ to hide this for all classes.
** If you want to add a new stratification class:
Step 3: Adding stratification class
Click on “Add new stratification class” at the bottom of the list. Now a pop up opens. Here you fill in the following information:
- Reference: A code, abbreviation or short name by which you recognize the stratification class in the future. For example: M20-40
- Description: The description of the stratification class. For example: Men between the 20 and 40 years.
- CRF-quantity: Here you determine how many patients can be put in this class. If the class in full, then people who comply with the class need to be, placed in a class they also comply with or they will not be able to be randomized.
- Block size: You can set up the block size within the CRF-quantities. These need to be dividable by the number of randomization options that fall in this class. By using the block size you increase the chance that the treatments are divided as fairly as possible during the study.
After you have filled in everything click on “Save and new” to save and immediately add another stratification class. Click on “Save and close” to save and close the pop up. To cancel click on “Close”.
** If you want to edit an existing stratification class:
Step 3: Edit stratification class
You can edit earlier made stratification classes. You do this by clicking on the pencil (edit) of the concerning class or by double clicking on the class.
Now a pop up opens. Here you can edit the information you filled in when making the new stratification class. When you are done click on “Save” or “Save and close”. To cancel click on “Close”.
** If you want to remove an existing stratification class:
Step 3: Removing stratification class:
You can remove a stratification class by clicking on the red remove-icon at the concerning class in the list. For confirmation a pop up will open. If you want to remove the class, click on “OK”. To maintain the class, click on “Cancel”. Classes you want to remove cannot already be in use.