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Distinguishing submission, receipt and assessment status

An internal report may show completion as soon as a team uploads an application.

Representative research photograph: Distinguishing submission, receipt and assessment status
Photo: Angel Turner · License: Public domain · Cropped and resized.
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An internal report may show completion as soon as a team uploads an application. Upload, technical submission, acknowledgement and assessment outcome are different events, however. Sponsors should define status labels clearly so downstream teams understand the evidence supporting any action based on that information.

Decision framework

Verify the platform's submission and status steps with an appropriate specialist. Identify the evidence and source behind each internal state. Do not present a technical receipt as scientific acceptance or authorisation to conduct the study. Also establish how subsequent platform warnings or deficiencies will reach the responsible owner for assessment.

Worked example

For example, files are uploaded but the final submission step remains incomplete. An internal schedule nevertheless reports that the application has been made, and another function plans around that date. A final check of the actual platform state reveals the discrepancy. The report is corrected without reinterpreting the upload date as an approval date, and affected plans are reassessed.

Implementation checks

  • Map internal status definitions separately to submission, acknowledgement and authorised assessment evidence rather than combining them into one label.
  • Identify who verifies the latest platform state and where the relevant supporting evidence will be retained.
  • If a status error is found, examine which teams made decisions using the earlier information and communicate the correction to them.

Acceptance and boundaries

Accept tracking when an independent reviewer can explain which event actually occurred. This example does not reproduce all status codes for a particular portal. Verify official states and necessary actions against current platform guidance; an internal commercial schedule cannot substitute for required authorisation.

Frequently asked questions

Does upload always mean submitted?
No. Verify applicable platform steps and the actual status.
Does acknowledgement authorise study start?
Do not assume that meaning; confirm necessary authorised assessments separately.

Sources

  1. EMA — CTIS sponsor handbook and support
  2. European Commission — Clinical trials framework