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

06.05.2021 / Оновлено: 25.05.2022 9810

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)

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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

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Annex 2 Requirements to informed consent

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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

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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

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Annex 5 Complete dossier of investigational medicinal product

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Annex 6 Application of principal investigator

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Annex 7 Information about health care setting and clinical trial site

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Annex 8 Notification about the start of clinical trial in Ukraine

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Annex 9 List of aspects of clinical trial which may be amended substantially by sponsor

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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

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Annex 11 Application for substantial amendment/approval of substantial amendment by the ethics committee at HCS

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Annex 12 Notification about completion of clinical trial

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Annex 13Periodical report on status of clinical trial in Ukraine

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Annex 14 Format of final clinical trial report

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Annex 15 Requirements to notification about suspected unexpected serious adverse reaction

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Annex 16 Requirements to development safety update report about investigational medicinal product (hereinafter — DSUR)

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Model Regulations of the Ethics Committees at health care settings which conduct clinical trials

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Отримуйте оновлення в телеграмі

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)

Model Regulations of the Ethics Committees at health care settings which conduct clinical trials

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