OpenClinica Randomize was introduced in OpenClinica version 3.9. This optional, add-on module is available to our Enterprise customers upon request on a study-by-study basis. Once you request access, your OpenClinica sales and support teams will work with you to get your study set up for randomization.
To Request OpenClinica Randomize:
On the Build Study page (Tasks > Study Setup > Build Study), in the Randomize line of the Modules section, click.
An on-screen message and email notification confirms your request and the Randomize status changes to Pending.
Configuring OpenClinica Randomize
Once Randomize has been enabled for your study, the OpenClinica team will take steps to ensure it is implemented appropriately per your study requirements. You will be able to choose from a variety of randomization protocols such as blocks, random permuted blocks, and minimization. OpenClinica Randomize also supports blinded and unblinded studies, allowing you to display either a treatment group name or treatment group code. You are able to use any CRF variables, and a variety of global variables as stratification factors (such as site) in your randomization.
Randomizing a Patient
The following is provided as an example of one implementation of Randomize based on a study with stratification variables of Age, Gender, and BMI. The steps below outline how to randomize on a patient-by-patient basis. Alternatively, you could randomize all non-randomized patients by running the Randomize rule in batch on the Manage Rules page.
1. In data entry, schedule and open the Randomization CRF:
2. Depending on your configuration either enter or review the inserted values for the stratification variables and click Save.
The Randomize Confirmation section displays:
3. Review and confirm the stratification values. To randomize the patient, select Yes and click Save.
The Randomization section displays with the randomization code in a read-only field:
4. Mark the CRF complete and click Save.
Disabling OpenClinica Randomize
Once all patients for a study have been randomized, you can request that Randomize is disabled. This maintains all of your randomization information for the study, but you will not be able to randomize any new patients.
To disable OpenClinica Randomize:
On the Build Study page (Tasks > Study Setup > Build Study), in the Randomize line of the Modules section, click .
The Randomize status changes to Disabled.
OpenClinica 3.9 Randomize Notes
Please note the following apply to the 3.9 release of OpenClinica Randomize:
- Patients can only be randomized once. If an error is made when entering any of the stratification values and a patient is randomized based on the incorrect value, that patient cannot be re-randomized even if the stratification value is later corrected. Your Randomize eCRF will be designed to include a confirmation screen that displays the stratification values prior to prompting you to confirm randomization.
- Though the Manage Rules page (Tasks > Monitor and Manage Data > Rules) displays Randomize rules and allows you to view and download those rules, those rules should not be edited. If you need any changes to anything in the randomization process, please contact your OpenClinica support team. Any changes you make to the rules may compromise your randomization.