PRECONDITIONS FOR STUDY START. Precondition for the start of the study is the approval of the project by the competent authority which will be applied by the CRO. Patient recruitment in the centre may only start on condition that the competent ethics commission has given its favourable opinion to the clinical study and the Institution’s/Investigator’s participation. Where necessary CRO will support the Institution/Investigator in the application procedure for the ethic commission’s opinion and notifications to the authorities concerned on participation of the Institution/Investigator as required by local regulations. CRO will not deliver any study medication to the study site unless confirmation is available that the above mentioned demands are met.
PRECONDITIONS FOR STUDY START. Precondition for the start of the study is the approval of the project by the competent authority (the State Institute for Drug Control) which will be applied by, and for which completeness and correctness as well as for the correctness of all further legal documentations for the implementation for the study, is responsible the CRO. Patient recruitment in the centre may only start on condition that the competent ethics commission has given its favourable opinion to the clinical study and the Institution’s/Investigator’s participation. Where necessary CRO will support the Institution /Investigator in the application procedure for the ethic commission’s opinion and notifications to the authorities concerned on participation of the Institution/Investigator as required by the law regulations of the Czech Republic. CRO will not deliver any study medication to the study site unless confirmation is available that the above mentioned demands are met.
PRECONDITIONS FOR STUDY START. Precondition for the start of the study is the approval of the project by the competent authority which will be applied by the CRO. Patient recruitment in the centre may only start on condition that the competent ethics commission has given its favourable opinion to the clinical study and the Institution’s/Investigator’s participation. Where necessary CRO will support the Institution/Investigator in the application procedure for the ethic commission’s opinion and notifications to the authorities concerned on participation of the Institution/Investigator as required by local regulations. CRO will not deliver any study medication to the study site unless confirmation is available that the above mentioned demands are met. Ethics Commission CRO will provide all documents needed for submission to the appropriate ethics commission. If accepted by the ethics commission, CRO will apply for the ethics committee’s opinion on behalf of the Investigator and pass the procedures. In case the ethics commission raises any objections against the subject or any procedures of the planned study, the contracting parties will discuss and propose modifications which meet the concerns of the ethics commission as well as the objectives of the study. The study may not start in the centre unless written evidence of approval of the appropriate ethics commission is available. The ethics commission must be informed on each modification and/or additional statement concerning the study protocol (amendments). CRO will provide all necessary documentation and will assist the Investigator in submission of any amendment or will inform the ethics commission directly, if accepted by the ethics commission. Notification of the Authority(ies) CRO will apply for study authorisation at the competent health authority and, if applicable, notify other authorities concerned on participation of the Investigator/the study site as required by local regulations and where necessary in agreement with Investigator. The Investigator will be informed in writing about the notifications done by CRO. The study may not start unless all needed approvals/confirmations by the authority(ies) are available. The responsible authorities may perform an inspection of the study site to verify the correct conduct of the study. PŘEDPOKLADY PRO ZAHÁJENÍ STUDIE Předpokladem pro zahájení studie je schválení projektu příslušným úřadem, o které požádá CRO. Nábor pacientů může v centru začít pouze v případě, že příslušná etická komis...
