• Partners

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

NBScience training hosted by ich-gcp.

Join now


Chat about what's on your mind. More about public chats.

 

 

 

 

 

 

International Committee of Medical Journal Editors (ICMJE): June 2007 editorial

 

International Committee of Medical Journal Editors (ICMJE): May 2005 editorial

 

WHO International Clinical Trials Registry Platform (ICTRP)

 

The World Health Organization announces new standards

for registration of all human medical research

 

WHO trial registration data set

 

 

 

Clinical Trials Registry

 

Good Clinical Practice (GCP) Certification Program Participants List

 

 

 

NBScience international

 

 

 

clinical trials,CRA,
CRO,GCP,ICH,ICH-GCP,
GLP,GMP,CRP,CRM,
CR,CMO,FDA,EFGCP,
ESMO,CME,clinical trial,
clinical research,
clinical research associate,
good clinical practice,
international conference
harmonization,
good laboratory practice,
good manufacturing practice,
clinical research monitor,
credit medical education,
certification,
online gcp,
online education,
medical conference,
congress,meeting,
medical event,symposium,
medical abstract,registry,
pharmaceutical company,
investigator,
auditor,gcp audit,
gmp audit,glp audit,
cGMP