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Decision

Notification of the decision on a clinical trial is done per MSc within five days from the reporting date or from the last day of the assessment part II.

The decision can be:

  • The clinical trial is authorised;
  • The clinical trial is authorised subject to conditions*;
  • The clinical trial is refused.

* An authorisation of a clinical trial subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation, e.g. submission of the minutes of the Data Safety Monitoring Board meetings (see question 2.8 of the Q&A document).

In case a MSc does not submit the decision in CTIS within 5 days, then a tacit Decision will automatically be generated:

  • If both part I and II conclusions are acceptable or acceptable with conditions, the application is automatically authorised;
  • If part I conclusion is acceptable or acceptable with conditions and part II conclusion is not acceptable or lacking, the application is automatically authorised;
  • If part I conclusion is not acceptable and part II conclusion is acceptable or acceptable with conditions, not acceptable or lacking, the application is automatically not authorised.

If part I conclusion is lacking and part II conclusion is acceptable or acceptable with conditions, not acceptable or lacking, the application is automatically still under evaluation.