http://unaparolaalgiorno.it/significato/D/dirimente

L'argomento dirimente è quello che da solo basta a risolvere una questione, che non necessita di altri argomenti satelliti d'appoggio;



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Note added at 9 hrs (2016-02-10 17:48:23 GMT)
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Requests to make substantial emendments can't be vague or general but need to be justified with specific reference to the details listed in that law (art.6 para 3 EN) //(art. 6 para 2 IT). See below

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:320...
http://www.camera.it/parlam/leggi/deleghe/03211dl.htm

Article 10

Conduct of a clinical trial

Amendments may be made to the conduct of a clinical trial following the procedure described hereinafter:

(a) after the commencement of the clinical trial, the sponsor may make amendments to the protocol. If those amendments are substantial and are likely to have an impact on the safety of the trial subjects or to change the interpretation of the scientific documents in support of the conduct of the trial, or if they are otherwise significant, the sponsor shall notify the competent authorities of the Member State or Member States concerned of the reasons for, and content of, these amendments and shall inform the ethics committee or committees concerned in accordance with Articles 6 and 9.

On the basis of the details referred to in Article 6(3) and in accordance with Article 7, the Ethics Committee shall give an opinion within a maximum of 35 days of the date of receipt of the proposed amendment in good and due form. If this opinion is unfavourable, the sponsor may not implement the amendment to the protocol.