eTMF API Integration

We're introducing new or enhanced Artifacts GET, POST, and PUT APIs in this release in support of the Oracle eTMF product.

Artifacts GET

The Artifacts GET response includes an "unblinded" field in support of Oracle eTMF functionality. As of the Oracle Site Activate 24.2 release, artifacts where unblinded = true cannot be called via API. They can be accessed via the Oracle Site Activate user interface by users with appropriate permissions. An API user calling Artifacts GET for a specific artifact (ex: /api/v1/artifacts?id=2144277) where unblinded = true, will receive a 403 Forbidden error message: "Unblinded documents cannot be returned via API call."

Artifacts POST and Artifacts PUT

The Artifacts POST API provides a route that creates a document placeholder based on a study’s configuration. An API user (e.g., CTMS or other partner) can use the Artifact POST message to add a file to a document placeholder. When successful, the file will be visible on the placeholder, the user name will be identified from the transmitter_email in the call, and the file_version will be set to 1.

Artifacts POST API accepts the inputs listed below and outputs an artifact ID and artifact URL. The API inputs are:

• artifact level (study, country, or site)
• study id (required)
• country code (required for country or site artifact level (2 or 3 characters))
• site id (required for site artifact level)
• artifact name (required, and will be held in a mapping table in CTMS and match the Oracle Site Activate configuration)
• unblinded status (Boolean (true/false), if not sent, default to false)
• tmf status (optional) values include:
  • Not Applicable
  • Not Started
  • Received from Site
  • Collected
  • Ready for Review
  • Approved
  • Rejected
  • TMF Ready
  • Inspection Ready
  • Obsoleted
  • Superseded

Use the Artifacts PUT API to replace a file on a document placeholder. When successful, the new file will be visible on the placeholder, and the replaced file moves to the placeholder’s “previous files” section. Also, the user name will be identified from the transmitter_email in the PUT call, and the file_version value will be incremented.