Audit by Biogen and Records Sample Clauses

Audit by Biogen and Records. The Institution shall permit Biogen and its agents during normal business hours and at mutually agreeable times, to inspect, audit, duplicate and/or make abstracts of records and reports collected and generated by the Institution and the Investigator in the course of conducting the Trial, as well any other documentation, data and information relating to the Trial, and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and the Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The Institution shall make the Investigator and other personnel following the instructions of the Investigator available to Biogen and its agents in order to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Biogen or its agents, the Institution and the Investigator shall immediately correct any errors or omissions in such records and reports. The Institution shall preserve all records relating to the Trial and the Subjects participating therein as required by the Protocol, the Applicable Laws and Regulations and Section 6(e) below, and shall, in writing, offer such records to Biogen before destroying or disposing thereof.
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Audit by Biogen and Records. The Institution shall permit Biogen and its agents during normal business hours and at mutually agreeable times, to inspect, audit, duplicate and/or make abstracts of records and reports
Sample 1
Audit by Biogen and Records. The Institution shall permit Biogen and its agents during normal business hours and at mutually agreeable times, to inspect and make abstracts of records and reports collected and generated by the Institution and the Investigator in the course of conducting the Trial and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and the Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The Institution shall make the Staff available to Biogen and its agents in order to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Biogen or its agents, the Institution shall and shall procure that the Staff shall immediately correct any errors or omissions in such records and reports. The Institution shall and shall procure that the Staff shall preserve all records relating to the Trial and the Subjects participating therein as required by the Protocol and otherwise in accordance with the Applicable Laws and Regulations and Section 6(e) below, and shall, in writing, offer such records to Biogen before destroying or disposing thereof.
Sample 1
Audit by Biogen and Records. The Institution shall permit Biogen and its agents during normal business hours and at mutually agreeable times, to inspect, audit, duplicate and/or make abstracts of records and reports collected and generated by the Institution and the Investigator in the course of conducting the Trial, as well any other documentation, data and information relating to the Trial, and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and the Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The Institution shall make the Investigator and other personnel following the instructions of the Investigator available to Biogen and its agents in order to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Biogen or its agents, the Institution and the Investigator shall immediately correct any errors or omissions in such records and reports. The Institution shall preserve all records relating to the Trial and the Subjects participating therein as required by the Protocol, the Applicable Laws and Regulations and Section 6(e) below, and shall, in writing, offer such records to Biogen before destroying or disposing thereof. Medical Records shall be maintained by the Institution in accordance with the Act No. 372/2011 Coll., on Medical Services and other Applicable laws and regulations. (b) Kontrola ze strany společnosti Biogen a záznamy. Ve vzájemně dohodnutém čase v rámci běžné pracovní doby umožní Zdravotnické zařízení společnosti Biogen a jejím zástupcům provést kontrolu, audit, okopírování anebo pořízení výňatku ze záznamů a zpráv shromážděných a vypracovaných Zdravotnickým zařízením a Zkoušejícím v průběhu provádění Klinického hodnocení, jakož i další dokumentace, údajů a informací týkajících se Klinického hodnocení a dále prohlídku zařízení, kde je Klinické hodnocení prováděno, k ověření plnění podmínek smlouvy, Protokolu a Platných zákonů a předpisů i přesnosti informací poskytovaných v souvislosti s Klinickým hodnocením. Zdravotnické zařízení umožní společnosti Biogen a jejím zástupcům, aby se setkali se Zkoušejícím a dalšími pracovníky, kteří plní pokyny Zkoušejícího, aby mohli dané záznamy a zprávy projednat a vyřešit jakékoliv otázky týkající se těchto záznamů a zpráv. Na žádost společnosti Biogen nebo jejích zástupců pak Zdravotnické zařízení a Zkoušející v těchto záznamech a zprávách neprodleně...
Sample 1
Audit by Biogen and Records. The InstitutionFoundation shall permit Biogen and its agents, during normal business hours and at mutually agreeable times, to inspect and make abstracts of records and reports collected and generated by the InstitutionFoundation and the Investigator in the course of conducting the Trial and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The InstitutionFoundation shall make the Investigator and other personnel following the instructions of the Investigator available to Biogen and its agents in (b) Auditoría realizada por Biogen y registros. La InstituciónFundación xxxxxx permitir que Biogen y sus agentes, durante las horas hábiles habituales y en momentos acordados mutuamente, inspeccionen y realicen resúmenes de los registros e informes obtenidos y generados por la InstituciónFundación y el Investigador en el transcurso de la realización del Ensayo, e inspeccionen las instalaciones en las que el ensayo se realiza para comprobar su cumplimiento con este Contrato, el Protocolo y las Leyes y Normativas Aplicables y la exactitud de la información proporcionada en relación con el Ensayo. La InstituciónFundación pondrá a disposición de Biogen order to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Biogen or its agents, the InstitutionFoundation and the Investigator shall immediately correct any errors or omissions in such records and reports. The InstitutionFoundation shall preserve all records relating to the Trial and the Subjects participating therein as required by the Protocol and otherwise in accordance with the Applicable Laws and Regulations, and shall, in writing, offer such records to Biogen before destroying or disposing thereof. y sus agentes al investigador y otros miembros del personal que sigan las instrucciones del Investigador, a fin de analizar dichos registros e informes y resolver cualquier pregunta relacionada con dichos registros e informes. A solicitud de Biogen o sus agentes, la InstituciónFundación y el Investigador corregirán de inmediato cualquier error u omisión en dichos registros e informes. La InstituciónFundación xxxxxx mantener todos los registros relacionados con el Ensayo y los Sujetos que participan en él según lo requerido por el Protocolo y de conformidad con las Leyes y Normativas Ap...
Sample 1
Audit by Biogen and Records. The Institution shall permit Biogen and its agents during normal business hours and at mutually agreeable times, to inspect, audit, duplicate and/or make abstracts of records and reports collected and generated by the Institution and the Investigator in the course of conducting the Trial, as well any other documentation, data and information relating to the Trial, and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and the Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The Institution shall make the Investigator and other personnel following the instructions of the Investigator available to Biogen and its agents in order to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Biogen or its agents, the Institution and the Investigator shall immediately correct any errors or omissions in such records and reports. The Institution
Sample 1
Audit by Biogen and Records. The Institution shall permit Biogen and its agents during normal business hours and at mutually agreeable times (as agreed to at least three (3) days in advance), to inspect and make abstracts of records and reports collected and generated by the Institution and the Investigator in the course of conducting the Trial and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and the Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The Institution shall make the Staff available to Biogen and its agents in order to discuss such records and reports and to resolve any questions relating to such records and reports. By above-mentioned activities of Biogen or its authorized representatives and representatives is not allowed to disrupt the standard operation of the Institution. At the request of Biogen or its agents, the Institution shall and shall procure that the Staff shall immediately correct any errors or omissions in such records and reports. The Institution shall and shall procure that the Staff shall preserve all records relating to the Trial and the Subjects participating therein as required by the Protocol
Sample 1
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Related to Audit by Biogen and Records

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