investigational product has been provided to the investigator 8.2.2 SIGNED PROTOCOL To document investigator and sponsor X X AND AMENDMENTS, IF agreement to the protocol/amendment(s) ANY, AND SAMPLE CASE and CRF REPORT FORM (CRF) 8.2.3 INFORMATION To document the informed consent X X GIVEN TO SUBJECT -INFORMED To document that subjects will be given FORM X X appropriate written information (content and (including all applicable wording) to support their ability to give fully translations) informed consent -ANY OTHER WRITTEN To document that recruitment measures are -ADVERTISEMENT FOR appropriate and not coercive SUBJECT RECRUITMENT X X (if used) 8.2.4 FINANCIAL ASPECTS To document the financial agreement X X OF THE between the investigator/institution and the sponsor for the trial
investigational product has been provided to the investigator 8.2.2 SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF) To document investigator and sponsor agreement to the protocol/amendment(s) and CRF X X 8.2.3 INFORMATION GIVEN TO SUBJECT -INFORMED FORM (including all applicable translations) -ANY OTHER WRITTEN -ADVERTISEMENT FOR SUBJECT RECRUITMENT (if used) To document the informed consent To document that subjects will be given appropriate written information (content and wording) to support their ability to give fully informed consent To document that recruitment measures are appropriate and not coercive X X X X X X 8.2.4 FINANCIAL ASPECTS OF THE To document the financial agreement between the investigator/institution and the sponsor for the trial X X
AVAREFGCPGuidelinev0_1.docx