Records Maintenance and Retention. Investigator and Institution will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, CRFs, accounting records, notes, reports, and data. Institution will perform free archiving for 5 years in accordance with Act No. 378/2007 Coll. and for the next 20 years it will perform paid archiving – xxxxx. Payment for paid archiving will be paid upon Xxxxxxx’x receipt of invoice after signing of this Agreement. The Sponsor shall notify the Institution 6 months in advance from the end of the charged archiving that it insists on further archiving and will cover the costs associated therewith. In the event that the Sponsor does not notify the request for further archiving or does not pay the fee for further archiving within the above- mentioned period, the Institution is entitled to liquidate all archived Study documents. In the event that no subject is enrolled into the clinical trial, the archiving fee will be refunded.
Records Maintenance and Retention. Investigator and Provider will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, CRFs, accounting records, notes, reports, and data. Provider will provide a free of charge archivation for a period of 5 years in accordance with the Act No. 378/2007 Coll. and for the following period of 10 years, the Provider will charge a fee in accordance with the terms stated in Exhibit A of this Agreement. The fee will be invoiced for after the execution of this Agreement. Zadavatel uhradí všechny náklady s archivací spojené. V případě, že Zadavatel neoznámí poskytovateli, že trvá na další archivací, má se za to, že byl udělen souhlas s likvidací všech dokumentů klinického hodnocení. Sponsor shall bear all costs of archivation. Unless Sponsor notifies the Provider that it insists on further archiving, Provider is entitled to destroy the study documentation once the 15 year archiving period has elapsed.
Records Maintenance and Retention. Investigator and Institution will maintain adequate and accurate records relating to the disposition of the Trial Drug and Comparator Drug, and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, CRFs, accounting records, notes, reports, and data. Institution will retain these documents for the time required by applicable regulations. Any additional archivation request above aplicable laws shall be brought by Sponsor at the time of site/documentation closure.