Intake-only processing for CROs

You can send files after intake processing to external systems with this Intake form enhancement.

Contract Research Organizations (CROs), which are responsible for Intake-only processing for their customers, leverage Consolidated Intake and send E2B messages to the sponsor’s safety database. Thus, the Intake-only processing feature has been enhanced to support a human-in-the-loop functionality for reviewing extracted data before submission and agency-based E2B generation.

Common Profile Switch rename

The Reporting Destination for Email Configuration Argus Console switch has been renamed to Reporting Destination (for E2B file and/or Email configuration).

E2B(R3) generation

Once Intake processing is complete, the E2B(R3) file for the Intake record is now generated based on the reporting destination selected in Console > System Configuration > Common Profile Switches > Intake > Intake Processing > Reporting Destination (for E2B file and/or Email configuration). Thus, the file is sent to the target system based on the selected method of submission, either e-mail address or E2B(R3) file format which is applicable for REST APIs.

All E2B(R3) profiles are available for selection from the Reporting Destination (for E2B file and/or Email configuration) drop-down.

Review Record task in Intake Worklist

Intake records are always marked for the Review Record task in the Intake Worklist, so that you can review the extracted data before submission.

Submit button

When you click Submit, validation checks for the generated E2B file are performed before the file is sent. These checks are based on the reporting destination you selected in the Reporting Destination (for E2B file and/or Email configuration) common profile switch.

Validation error messages are either displayed in the Intake form or in a structured ICSR validation report.

Intake ID

In the generated E2B file, the Intake ID is now included as a Safety Report Unique Identifier, regardless of whether the record is transmitted via API or email.