substantial amendment notification form( cf. section（实质性的修正案通知表单(cf。部分）（6页）.docVIP

Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial) NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE EUROPEAN UNION For official use: Date of receiving the request?: Grounds for non acceptance/ negative opinion : ( Date : Date of s