ODM-XML extract

Sponsor users can extract study data, admin data, and metadata in an ODM-XML format to either store, analyze, or submit it to other systems.

Prerequisites

There are two prerequisites you must follow before you can run ODM-XML data extracts.

  • Create the required users in Oracle Life Sciences IAMS in order to use the Oracle Clinical One Analytics ODM APIs. See Create a user account in Oracle Health IAMS in the REST API for Clinical One Cloud Service user guide.
  • Assign the ODM Extract study role to your users in Clinical One Cloud Service. See Assign a study role to a user in the Add Users Guide.

To learn more about the ODM Extract permissions, see ODM Extract Permissions.

To learn more about ODM-XML data extracts, see Generate ODM-XML data extracts.

Types of data that you can extract

Here's a list of specific data types that you can typically extract:

  • Subject data: This includes visits, forms, items, but not queries.
  • Scope: Transactional or snapshot.
    • Transactional data reflects incremental data changes with audit information.
    • Snapshot data reflects current data only.
  • Blind data: Blinded or unblinded data.
  • Time range: Data created or updated between two points of time.
  • Study mode: Test, Training, or Production data.
  • Data generated without Clinical One Cloud Service extensions, conforming to the CDISC ODM-XML standard.
The data can additionally be partitioned and consumed using pagination parameters. The following parameters can be used:

Note:

Pagination parameters do not work if both Sites and Users are included in the API request.
  • offset: Row number to start on. First page starts with 0.
  • limit: Number of rows to return.

Parent topic: Data extract descriptions