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ORDER OF THE MoH OF UKRAINE 23.09.2009 No. 690 (as amended) On approval of the Procedure for conducting clinical trials of medicinal products and expert evaluation of clinical trial materials and the Model Regulations on Ethics Committees

06.05.2021 Updated 30.04.2026 19384 views

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 No. 690, registered at the Ministry of Justice of Ukraine on 29.10.2009 under No. 1010/17026 (as amended)DOCX · 121 KB · 22.10.2026

Annex 1 List of main documents pertinent to clinical trial that are to be kept at health care setting (HCS), clinical trial site and sponsorDOCX · 18 KB · 22.10.2026

Annex 2 Requirements to informed consentDOCX · 14 KB · 22.10.2026

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 productDOCX · 14 KB · 22.10.2026

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 productDOCX · 42 KB · 22.10.2026

Annex 5 Complete dossier of investigational medicinal productDOCX · 14 KB · 22.10.2026

Annex 6 Application of principal investigatorDOCX · 16 KB · 22.10.2026

Annex 7 Information about health care setting and clinical trial siteDOCX · 22 KB · 22.10.2026

Annex 8 Notification about the start of clinical trial in UkraineDOCX · 18 KB · 22.10.2026

Annex 9 List of aspects of clinical trial which may be amended substantially by sponsorDOCX · 15 KB · 22.10.2026

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 amendmentsDOCX · 14 KB · 22.10.2026

Annex 11 Application for substantial amendment/approval of substantial amendment by the ethics committee at HCSDOCX · 22 KB · 22.10.2026

Annex 12 Notification about completion of clinical trialDOCX · 19 KB · 22.10.2026

Annex 13Periodical report on status of clinical trial in UkraineDOCX · 19 KB · 22.10.2026

Annex 14 Format of final clinical trial reportDOCX · 18 KB · 22.10.2026

Annex 15 Requirements to notification about suspected unexpected serious adverse reactionDOCX · 17 KB · 22.10.2026

Annex 16 Requirements to development safety update report about investigational medicinal product (hereinafter — DSUR)DOCX · 19 KB · 22.10.2026

Table of contentsDOCX · 16 KB · 22.10.2026