- Main menu -> Management -> Stratification;
- Click on ‘Add Condition’ at a class.
- Choose the desired component details;
- Click on ‘Save’.
If you have the role of application manager, data manager or randomization manager in this module, then you can link conditions to stratification classes. Attention: if the randomization table has been generated, it is no longer possible to add conditions. So, it is of importance that you set up the stratification classes in the right way before you generate the randomization table.
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 “EDC (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? Then go to the support page ‘Enabling stratification and randomization’ to read how to add randomization to your study.
Step 2: Overview stratification classes
Now, you find yourself on the page with stratification classes. You see per class the reference, description, the maximum number of patients allowed in the class, and the block size. Every stratification classis linked to zero or multiple conditions.
You can see those when you click on the arrow left to the class. You can also show all the information of the classes at the same time by clicking on “Unfold all”. Click on “Fold all” to hide it for all classes.
Step 3: Add condition per class
In the list with stratification classes you can add a condition to every class. This way you link the classes to components in the study template. For example, if you have the stratification class “Men between 20 and 40 years”, you link a component that asks about the gender, and a component that asks about age, to this stratification class.
To add a condition you click on the button “Add condition”, on the right side of every class.
Now a pop-up opens. In the drop down at “Template component” you can navigate to the component you want to add to the stratification class. Dependent on the kind of component you chose, the dropdown changes at “Type condition”.
In this second dropdown choose the type of condition you want to add for the selected class, for example “Equal to” or “Larger than”. Finally, you fill in the desired value in the input field of the dropdown that eventually appeared (dependent on the type of condition, it appears for example at “Empty” or “Not empty”).
To save the condition and add another condition to the same stratification class, you click on “Save and New”. To save the condition and close the pop-up, click on “Save and Close”. To cancel click on “Close”.
A condition that has been added to a stratification class, can be seen on the list if you unfold the class. On the right next to the condition you then see two icon: a pencil (edit), on which you can click to edit the condition, and a remove icon, on which you can click to remove the condition.