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Conclusion and opt out

The conclusion of the assessment part I or part II may be:

  • Acceptable
  • Acceptable subject to conditions*
  • Not acceptable

* 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).

Part I conclusion accepted by rMS - MSc can opt out

If the conclusion of the rMS on part I is that the clinical trial is acceptable or acceptable subject to conditions that conclusion will be the conclusion of all MSc.

It is possible for a MSc to opt out, and issue a disagreement on conclusion part I, on basis of one or more of the following grounds:

  • If participation in the clinical trial would lead to a subject receiving an inferior treatment than in normal practice in het MSc;
  • Infringement of its national law with respect to prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from those cells, or of medicinal products used as abortifacients or of medicinal products containing narcotic substances;
  • Considerations made by MSc as regards to subject safety and data reliability and robustness.

Part I conclusion not accepted by rMS - no opt out for MSc

If the conclusion of the rMS on part I is that the clinical trial is not acceptable, that conclusion will be the conclusion of all MSc. It is not possible to opt out as MSc, meaning that the clinical trial cannot be authorised in a MSc where the conclusion of part I by the rMS is negative. This means that in all MSc (including the rMS) the clinical trial is not authorised.