Step 1. Preparation

Ready to set up this integration? Here’s what you need first.

• A Oracle Clinical One Platform global user account, which requires the following roles to be able to set up this integration:
  • The ClinicalOne_Production or clinicalone-CNE role from Oracle Life Sciences Identity and Access Management Service.

    Your delegated administrator can create the account for you, if you don’t already have an account, and assign these roles to it.

  • The Integration Manager global role from Oracle Clinical One Platform.

    Your Oracle Clinical One Platform system administrator can assign this role to your account.

  For delegated administrators: How do you create this account?

• An account with write privileges for the SFTP server that your instance of Oracle Argus Safety uses. If possible, get an account with a password that won't expire. If you don't already have one, contact Health Sciences Support to request one.

  You need this account to create the SFTP credential key. Oracle Clinical One Digital Gateway uses the credential key so that it can place the E2B+ R2 files which contain the safety data on the SFTP server for Oracle Argus Safety.

• The path (from the server home) to a folder where Oracle Clinical One Digital Gateway should place the E2B+ R2 files for Oracle Argus Safety.

  Use the SFTP account to log in to the server, create necessary folders, and note their paths.

  Tip:

  You can choose to use separate folders on the SFTP server for the test integration and production integration, but you don't have to.
• The Annotated Study Book from Oracle Central Designer for the study you are integrating.

  If you plan on testing the integration on a different study that the one you intend to integrate, you will need the Annotated Study Book for that study, too. The instructions in this guide assume you are using the same study.

  If you don't have these documents, request them from your Oracle Central Designer study designer.

  You need them to get the codelist values from Oracle InForm which will be the source values for the codelist in the Oracle Clinical One Digital Gateway configuration file. The investigational product name (drug name) is also included in the Annotated Study Book.