Create the randomization design

Make a POST request to create a randomization design with three adaptive cohorts and apply it to the study.

Note:

• To run these Oracle Clinical One Platform API calls, you need to include an authentication token. For instructions on how to generate your authentication token, see Get a token for authentication and Use the token to make an API request.
• For every API call make sure you construct the URL using the correct server URL and path parameters values.

For the following API calls, you need the studyID and version. These values are retrieved as part of a prerequisite, see Get study information.

Step 1: Create the request payload File

With given treatment arms and their ids, create a new JSON file called Randomization.json and copy the following code. This will create a central randomization design using three adaptive cohorts as the treatment arms for the blinded study.

Note:

Make sure you replace the id with the correct value for each treatment arm.

{
    "details":
    {
        "title": "Randomization for Protocol",
        "description": "Central randomization. 3 treatment arms: 1:1:1",
        "studyId": "null",
        "cohortType": "NoCohort",
        "algorithm": "Central",
        "randomizationType": "Blinded",
        "reRandomization": "false",
        "treatmentArms": null
    },
    "arms": [
    {
        "id": "E322F08E38124329BD185847AFD971E8",
        "name": "10 mg dose",
        "ratio": "1"
    },
    {
        "id": "E322F08E38124329BD185847AFD971E9",
        "name": "5 mg dose",
        "ratio": "1"
    },
    {
        "id": "E322F08E38124329BD185847AFD971E0",
        "name": "Placebo dose",
        "ratio": "1"
    }],
    "settings":
    {
        "randomizeSubjectsIfSitesOutOfKits": 1,
        "assignSkippedRandomizationNumbers": 1,
        "randomizeLimitsToCountEarlyTerminated": 0,
        "randomizeNumberBlinded": 0,
        "assignNewRandomizeNumbers": null
    }
}

Step 2: Create randomizaton design using payload file

Run the following cURL command to create a central randomization design using the request payload file:

curl -X POST "https://tenant.clinicalone.oraclecloud.com/ec-designer-svc/rest/studies/{studyId}/versions/{version}/randomizations" -d "@Randomization.json"

To make subsequent calls for the randomization design you just created, take note of its id value. In order to create a assign a randomization design to a visit using Rest APIs you will need this data.

For more information on how to build the payload and other parameters, see Create randomization design.

Tip:

There may be different ways to create a randomization design according to the protocol requirements. Browse for these and other related APIs under the Tasks section of this guide. If you see any deprecated endpoint, look for its newest version.