PREMATURE TERMINATION OF THE STUDY. The competent authority may suspend or withdraw the approval for conduction of a clinical trial. In this case the clinical study may not be continued. The Sponsor will inform the Institution/Investigator immediately about such a decision of the authority and instruct the Investigator on treatment of patients still being in the study at the time of interruption or premature termination. PŘEDČASNÉ UKONŘENÍ STUDIE Odpovědné úřady mohou pozastavit nebo odvolat souhlas s provedením klinické studie. V takovém případě nesmí klinická studie pokračovat. Zadavatel bude o tomto rozhodnutí úřadů okamžitě informovat Institituci/Zkoušejícího a poučí Zkoušejícího ohledně léčby pacientů, kteří se účastnili studie v době přerušení nebo předčasného ukončení. RENUMERATION Provided that the study is performed in accordance with the study protocol and complete and evaluable documentation is supplied to CRO according to the predetermined time schedule, investigational fees of 1000 € will be paid per patient for whom the documentation is complete. These fees of 1000 € maximum per completed patient include investigator’s fee, but also any pharmacy fees, hospital over costs for study specific procedures and any other costs related to the study. No fees will be accepted for screen failures. The investigational fees per patient will be 1000 € and distributed as follows: Screening/ Pre-treatment phase (V0): 250 € Baseline/Randomization (V1): 150 € Hospital Discharge (V2): 150 € Final assessment (V3): 350 € Safety Follow-up Phone contact (V4): 100 € The Institution fixed fee (administrative fixed costs, project management, archiving…) will be 925 €. Pharmacy fee will be 480 €. Services requested by the study protocol may not be invoiced to the patient’s insurance carrier. In case of study protocol deviation which results in the patient’s exclusion from evaluation (e.g., patient does not meet the inclusion/exclusion criteria, missing and/or implausible efficacy and safety data), no payment will be made for the respective patient. The amounts defined above will be paid to the Institution on presentation of a revenue order or an invoice issued by the Institution at least once a year on the anniversary date of the signature of the agreement, on the basis of the information provided by the CRO (number of patients selected, number of patients included, visits and actions actually performed), after approval by the Institution to the bank account entered below. The revenue orders or invoices ...
PREMATURE TERMINATION OF THE STUDY. Kompetentní orgán může pozastavit nebo stáhnout souhlas s prováděním klinického hodnocení spadající do jeho odpovědnosti. V tomto případě nesmí klinické hodnocení pokračovat. Zadavatel bude neprodleně informovat zdravotnické zařízení/zkoušejícího o takovém rozhodnutí orgánu a vydá zkoušejícímu pokyn, jak postupovat u pacientů, kteří se v době přerušení či předčasného ukončení stále ještě klinického hodnocení zúčastní. The competent authority may suspend or withdraw the approval for conduct of a clinical trial of its responsibility. In this case the clinical study may not be continued. The Sponsor will inform the Institution/Investigator immediately about such a decision of the authority and instruct the Investigator on how to proceed with patients still being in the study at the time of interruption or premature termination.
PREMATURE TERMINATION OF THE STUDY. The competent authority may suspend or withdraw the approval for conduction of a clinical trial of its responsibility. In this case the clinical study may not be continued. The Sponsor will inform the Institution/Investigator immediately about such a decision of the authority and instruct the Investigator on treatment of patients still being in the study at the time of interruption or premature termination. 17. PŘEDČASNÉ UKONŘENÍ STUDIE Odpovědné úřady mohou ze svého postavení pozastavit nebo odvolat souhlas s provedením klinické studie. V takovém případě nesmí klinická studie pokračovat. Zadavatel bude o tomto rozhodnutí úřadů okamžitě informovat Institituci/Zkoušejícího a poučí Zkoušejícího ohledně léčby pacientů, kteří se účastnili studie x xxxx xxxxxxxxx xxxx xxxxxxxxxxx xxxxxxxx.
PREMATURE TERMINATION OF THE STUDY. The Sponsor may terminate this study prematurely for any reasonable cause. The Institutional Review Boards (IRB)/ Independent Ethics Committees (IEC) and regulatory authorities should be informed promptly. Conditions that may warrant termination include, but are not limited to: • The discovery of an unexpected, significant, or unacceptable risk to the subjects enrolled in the study, or potential study subjects • A decision on the part of the Sponsor to suspend or discontinue development of study treatment If the study is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the study subjects and ensure appropriate follow-up is provided for the subjects
PREMATURE TERMINATION OF THE STUDY. The sponsor has the right to terminate the trial prematurely if there are any relevant medical or ethical concerns, or if completing the trial is no longer feasible. If such action is taken, the investigator must inform all subjects and ensure appropriate care and follow up. The reasons for terminating the trial must be documented in detail and the Ethics Committee must be given a written explanation. Premature termination of the trial will be considered if:
