1 About Consolidated Intake

Consolidated Intake is an advanced pharmacovigilance system that optimizes the handling of Adverse Event (AE) documents in a unified user interface. It is included as part of your Oracle Safety One Argus subscription.

Consolidated Intake provides multiple options for ingesting AE documents, including manual uploads, automatic uploads via API, email, or Electronic Data Interchange (EDI).

Consolidated Intake processes AE documents into cases, in a sequential workflow. The workflow is as follows:

  1. Via email, API, Electronic Data Interchange or through direct user upload, documents are ingested by Consolidated Intake.
  2. As part of this step, Consolidated Intake marks records that require manual review - this may involve reviewing and confirming extracted information, correcting validation errors, or providing any missing data.
  3. Consolidated Intake classifies the E2B document. If you have the Oracle Safety One Intake add-on, the document is classified according to your extraction configuration.
  4. To extract adverse event data from the document, Oracle Safety One Intake uses advanced AI (Artificial Intelligence) and ML (Machine Learning) techniques that can extract relevant attributes from structured (like the CIOMS form) and unstructured (like an email) source files. As part of this step, Oracle Safety One Intake marks records that require manual review, which can involve reviewing and confirming extracted information, correcting validation errors, or providing any missing data. For unidentified documents, the option to perform manual data entry is available.

    Note:

    This piece of the workflow requires an additional subscription to Oracle Safety One Intake. This can be added to your Oracle Safety One Argus suite to harness the power of AI during AE extraction of structured and unstructured documents.

    Caution:

    AI-powered automatic extraction from source documents is for evaluation purposes only. Please review the output thoroughly before use.
  5. For E2Bs, the system checks the document against other, already ingested documents, marking it for Duplicate Search or Merge Follow-up. Users manually compare the data of records with these statuses, then either accept or reject them.
    • If the source is configured for auto-acceptance, the system creates a new case from the E2B or merges it as a follow-up without the need for additional manual intervention.
  6. If the target system is configured to accept data automatically, the data will be converted into a new case or will be merged with an existing one.