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Preparing evidence and decision routes for submission portal interruptions

A portal interruption on submission day can prompt different teams to try competing solutions, leaving completed steps uncertain.

Representative research photograph: Preparing evidence and decision routes for submission portal interruptions
Photo: U.S. Navy photo by [null Courtesy] · License: Public domain · Cropped and resized.
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A portal interruption on submission day can prompt different teams to try competing solutions, leaving completed steps uncertain. Sponsors should document the problem and reach the correct support route without inventing an official alternative channel or assuming that an interruption changes a deadline automatically.

Decision framework

Identify platform support resources and the authorised regulatory contact route before filing. Check relevant guidance for evidence needed during an interruption. Error messages, transaction times and file status may help, while screenshots should not expose unnecessary personal or confidential information. Specialists should verify any proposed alternative filing method through the applicable official process.

Worked example

For example, connectivity fails during final submission and staff do not know whether to repeat the action. The record owner coordinates actual status checks and a support request. The same package is not sent randomly through several channels. The support response is retained alongside the authorised assessment determining what action should follow.

Implementation checks

  • Separate the time, attempted step and observed platform state in the interruption record rather than describing everything simply as failure.
  • Share only the information needed to explain the problem through a suitable, secure support channel.
  • Define which activities should wait and who will decide the next action while the technical position remains unresolved.

Acceptance and boundaries

Accept the plan when the team routes technical uncertainty appropriately and can explain the application's actual state. This example claims neither automatic deadline extension nor validity of another filing channel. Verify the official approach through current guidance and authorised communication, preserving important evidence of attempted and completed transactions.

Frequently asked questions

Does a portal error automatically extend a deadline?
Do not assume so; confirm the applicable approach through authorised sources.
Can the package be emailed instead?
Verify acceptance of any alternative through the relevant official process.

Sources

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