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Adding randomization options

  • Bijgewerkt

Steps

  1. Main menu - > Management - > Randomization;
  2. Tab ‘Settings’;
  3. Click on “Add option” in a class on the right side of your screen;
  4. Fill in the desired information;
  5. Click on ‘Save’.

Extensive steps

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 Randomization

Now you see the starting page. Click at the top, in the menu bar, on “Management”. Then, click on “Randomization” under the heading “Study-settings”. Do you not see this option? Got to the page “Enabling stratification and randomization” to read how you can add randomization to your study.

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Step 2: Randomization overview

Now you find yourself on the settings page of randomization. Here you see all the stratification classes for this study. Are there no set-up stratification classes yet? Then you will need to set those up first. You can read more about setting up stratification classes on the page “Managing stratification classes”.

You can see the  reference, description, the maximum number of patients that are allowed in the class and the block size per class. You can add options to every stratification class.

You can see already added options when you click on the arrow on the left of the class. You can also show the information of all these classes by clicking on “Unfold everything”. Click on “Fold up” to hide the information of all the classes again.

DM_R_S_4_2_1.png

Step 3: Adding randomization options

Randomization options determine where patients from a stratification class can be randomized in. Every class needs at least two options (for example, a group that gets a new medicine and a group that gets a placebo).

To add an option, click on the icon that is behind the class in the column “Add option”. In the pop-up that opens, at the top you see the information about stratification classes, of the classes you are adding the option to. Then you fill in the reference and the name of the option. If you want to add an option to all stratification classes, you check “Add to all stratification classes”.

Do you want to save the option and add another option to the same class? Then click on “Save and new”. If you do not want to add any other options to this class, click on “Save and Close”. If you do not want to save the option you just filled in, click on “Close”.