HSC (Germany) ,
Institute of Clinical Research,
First Clinical Research LLC,
GCP Association,
European Forum of GCP,
International Biopharmacutical Association
CLINICAL TRIALS 2010
Approval of Procedure for Conducting Clinical Trials of Medicinal Products in Ukraine
ORDER MoH Ukraine of 23.09.2009 № 690
About Approval of Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees Registered at the Ministry of Justice of Ukraine on 29.10.2009 under № 1010/17026
PROCEDURE FOR CONDUCTING CLINICAL TRIALS OF MEDICINAL PRODUCTS AND EXPERT EVALUATION OF MATERIALS PERTINENT TO CLINICAL TRIALS
Annex 1 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials LIST OF MAIN DOCUMENTS PERTINENT TO CLINICAL TRIAL THAT ARE TO BE STORED AT HEALTH CARE SETTING (HCS)/CLINICAL TRIAL SITE AND SPONSOR
Annex 2 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials COVER LETTER To the application for getting conclusion of the State Pharmacological Center MoH Ukraine about clinical trial of medicinal product To the application for getting approval of the Central Ethics Committee MoH Ukraine pertinent to the clinical trial of medicinal product
Annex 3 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials APPLICATION FORM REQUEST FOR GETTING CONCLUSION OF THE STATE PHARMACOLOGICAL CENTER MOH UKRAINE/APPROVAL OF THE CENTRAL ETHICS COMMITTEE PERTINENT TO CONDUCTING CLINICAL TRIAL OF MEDICINAL PRODUCT
Annex 4 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials COMPLETE DOSSIER OF INVESTIGATIONAL MEDICINAL PRODUCT
Annex 5 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials TEMPLATE APPLICATION OF PRINCIPAL INVESTIGATOR
Annex 6 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials INFORMATION ABOUT SPECIALIZED HEALTH CARE SETTING (HEREINAFTER - HCS) AND CLINICAL TRIAL SITE
Annex 7 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials NOTIFICATION ABOUT THE START OF CLINICAL TRIAL IN UKRAINE
Annex 8 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials LIST OF ASPECTS OF CLINICAL TRIAL WHICH MAY BE AMENDED SIGNIFICANTLY BY SPONSOR
Annex 9 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials COVER LETTER To the application for getting conclusion of the State Pharmacological Center MoH Ukraine regarding significant amendments to materials pertinent to clinical trial To the application for approval of the Central Ethics Committee MoH Ukraine regarding significant amendments to materials pertinent to clinical trial
Annex 10 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials APPLICATION FORM REQUEST FOR CONCLUSION OF THE STATE PHARMACOLOGICAL CENTER MOH UKRAINE AND FOR APPROVAL OF THE CENTRAL ETHICS COMMITTEE MOH UKRAINE PERTINENT TO SIGNIFICANT AMENDMENT TO CLINICAL TRIAL DOCUMENTS
Annex 11 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials NOTIFICATION ABOUT COMPLETION OF CLINICAL TRIAL
Annex 12 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials PERIODICAL REPORT ON STATUS OF CLINICAL TRIAL IN UKRAINE
Annex 13 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials FORMAT OF FINAL CLINICAL TRIAL REPORT
Annex 14 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials REQUIREMENTS TO NOTIFICATION ABOUT SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION
Annex 15 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials REQUIREMENTS TO PERIODICAL SAFETY UPDATE REPORT ABOUT INVESTIGATIONAL MEDICINAL PRODUCT
MODEL REGULATIONS OF THE ETHICS COMMITTEES
(State Pharmacological Centre of the Ministry of Health of Ukraine
http://www.pharma-center.kiev.ua)
_____________________________________________________________
CLINICAL TRIALS TRAININGS IN UKRAINE:
1) "Clinical Trials: ICH- GCP rules, regulatory (EMEA, FDA) GCP
inspections. Key documents.", international seminar (GCP certification)
January 30,2010
2) On-line trainings
April 2009- April 2010
NBSCIENCE ALL-UKRAINIAN CLINICAL TRIALS REGISTRY
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