《box below.》.pdfVIP

Annex 1: Clinical trial Application Form REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY For official use: Date of receiving the request: Date of request for additional Grounds for non acceptance/ information: negative opinion: Date of request for information to Give date: make it valid: Date of valid application: Date of receipt of additional / amended Authorisation/ positive opinion: information: Give date: Date of start of procedure: Competent authority registration number: Withdrawal of application Ethics Committee registration number: Give date: To be filled in by the applicant: The questions in this form for the request for authorisation from the Competent Authority are also relevant for the opinion from an Ethics Committee (it represents module 1 of the form for applying to an ethics committee) and can be used as part of that application. Please indicate the relevant purpose in a box below. REQUEST FOR AUTHORISATION TO THE COMPETENT AUTHORITY: REQUEST FOR OPINION OF THE ETHICS COMMITTEE: A TRIAL IDENTIFICATION A.1 Member State in which the submission is being made: A.2 EudraCT number A.3 Full title of the trial: A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language: A.3.2