НАКАЗ МОЗ УКРАЇНИ 23.09.2009 № 690 (із змінами) Про затвердження Порядку проведення клінічних випробувань лікарських засобів та експертизи матеріалів клінічних випробувань і Типового положення про комісії з питань етики
Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees approved by MoH Ukraine Order of 23.09.2009 № 690, registered at the Ministry of Justice of Ukraine on 29.10.2009 under № 1010/17026 (as amended)
Annex 1 List of main documents pertinent to clinical trial that are to be kept at health care setting (HCS), clinical trial site and sponsor
Annex 2 Requirements to informed consent
Annex 3 Cover letter To the application for conducting clinical trial of medicinal product to be submitted to the central executive body: To the application for getting approval of the Ethics Committee at HCS pertinent to the clinical trial of medicinal product
Annex 4 Application form For conducting clinical trial of medicinal product/approval of the ethics committee at HCS pertinent to conducting clinical trial of medicinal product
Annex 5 Complete dossier of investigational medicinal product
Annex 6 Application of principal investigator
Annex 7 Information about health care setting and clinical trial site
Annex 8 Notification about the start of clinical trial in Ukraine
Annex 9 List of aspects of clinical trial which may be amended substantially by sponsor
Annex 10 COVER LETTER To the application to the central executive body regarding substantial amendments: To the application for approval of the Ethics Committee at HCS regarding substantial amendments
Annex 11 Application for substantial amendment/approval of substantial amendment by the ethics committee at HCS
Annex 12 Notification about completion of clinical trial
Annex 13Periodical report on status of clinical trial in Ukraine
Annex 14 Format of final clinical trial report
Annex 15 Requirements to notification about suspected unexpected serious adverse reaction
Annex 16 Requirements to development safety update report about investigational medicinal product (hereinafter — DSUR)
