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EudraCT legacy results: reconcile the reporting destination

A legacy portfolio needs a study-by-study reporting map; the existence of CTIS does not erase older disclosure records.

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A legacy portfolio needs a study-by-study reporting map; the existence of CTIS does not erase older disclosure records.

EudraCT legacy results — Define the regulatory scope

EMA continues to provide EudraCT result functionality. Determine the applicable reporting destination from the trial history and transition status rather than its publication date.

EudraCT legacy results — Build the working record

Create an identifier crosswalk linking EudraCT number, any CTIS record, countries, end dates and posted results. Mark missing, inconsistent or superseded records and identify who holds valid access to correct them.

EudraCT legacy results — Check before release

  • Verify trial identity before copying results.
  • Reconcile country status with documented history.
  • Keep receipts for each applicable reporting system.

EudraCT legacy results — Record the decision and handover

Approve a remediation plan with prioritised discrepancies and accountable owners. Avoid duplicate or contradictory public updates; document why each system requires an action and check the public record after completion.

Frequently asked questions

Should every legacy trial be recreated in CTIS?
No. Establish the appropriate workflow from its regulatory history.
Does posting a journal link resolve missing register data?
Not automatically. Check the actual results requirements and required data fields.

Sources

  1. Primary requirement: EMA EudraCT: results workflows
  2. Operational guidance: EMA CTIS handbook: transitioned trials