EC Approval. The Study shall not commence until Institution has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for use; the Protocol; and the participation of Institution and any Research Personnel in the Study. All modifications to the Protocol shall be made by the Sponsor and shall not be implemented by any Investigator until receipt of any necessary FDA or EC approvals. Modifications to the Informed Consent shall be agreed upon by the Sponsor and the Principal Investigator, and shall not be implemented by any Investigator until receipt of EC written approval. Institution agrees that any conditions of approval imposed by the EC shall be adhered to.
EC Approval. The Company will obtain approval of the applicable Protocol from the Local Ethics Committee and Multicentric Ethics Committee and any other applicable independent data safety and/or clinical trial subject monitoring board or
EC Approval. The Company will obtain approval of the applicable Protocol from the Local Ethics Committee and Multicentric Ethics Committee and any other applicable independent data safety and/or clinical trial subject monitoring board or equivalent entity (“EC”), as Instituce. Instituce poskytne veškerý personál, a to zejména včetně odborných pracovníků na úseku laboratoře, lékárny a klinické podpory a xxxx lékaře v míře dostatečné pro účely včasného a řádného dokončení každého Klinického hodnocení. Služby Hlavního Zkoušejícího jsou nezbytné k provádění Klinického hodnocení. Pokud ukončí Hlavní Zkoušející jeho/její vztah s Institucí, nebo pokud z nějakého jiného důvodu není Hlavní Zkoušející k dispozici nebo není-xx xxxxxxx zajistit výkon Klinického hodnocení, Instituce okamžitě oznámí Zadavateli tuto skutečnost. Instituce oznámí v písemné podobě Společnosti, pokud Hlavní Zkoušející plánuje ukončit pracovní poměr v Instituci a Instituce poskytne (a) nové kontaktní údaje týkající se navrhovaného nástupce za Hlavního Zkoušejícího, a (b) zajistí, že Hlavní Zkoušející poskytne rozumnou podporu při přechodu povinností Hlavního Zkoušejícího na nového nástupce. Nelze-li nalézt náhradu přijatelnou pro Společnost, může Společnost od této Smlouvy odstoupit způsobem v této Smlouvě stanoveným v článku 14.3. Pokud je náhrada nalezena, nový nástupce Zkoušejícího by xxx podepsat dokumentaci poskytnutou Společností v souvislosti s akceptací nových povinností vyplývajících z role Hlavního Zkoušejícího.
EC Approval. The Sponsor will obtain approval of the applicable Protocol from the Local Ethics Committee and Multicentric Ethics Committee and any other applicable independent data safety and/or clinical trial subject monitoring board or equivalent entity (“EC”), as well as any other approvals required by the Provider and Applicable Law (defined below) in particular the approval of State Institute for Drug Control (“SÚKL”), to perform the Clinical Trial. No modifications will be made to the Protocol unless agreed in writing by the Sponsor and the Provider. No study subject treatments will be initiated prior to receipt of EC / SÚKL approval and any other compliance with Applicable Law and approvals required to conduct the Clinical Trial. poskytnutou Zadavatelem v souvislosti s akceptací nových povinností vyplývajících z role Hlavního Zkoušejícího.
EC Approval. According to the Agreement on Cooperation between Institution and the founders Thomayerova nemocnice, ID: 00064190, registered office in Xxxxx 0, Xxxxxxxx 800, ZIP xxxx 000 00, Xxxxx Xxxxxxxx and Institut klinicke a experimentalni mediciny, ID: 00023001, registered office in Xxxxxxxx 0000/0, 000 00 Xxxxx 0, Xxxxx Xxxxxxxx, the founded ethics committee performs for the Institution the Study assessment within the scope of work of local ethics committee. The Study shall not commence until Institution has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for use; the Protocol; and the participation of Institution and any Research Personnel in the Study. All modifications to the Protocol shall be made by the Sponsor and shall not be implemented by any Investigator until receipt of any necessary FDA or EC approvals. Modifications to the Informed Consent shall be agreed upon by the Sponsor and the Principal Investigator, and shall not be implemented by any Investigator until receipt of EC written approval. Institution agrees that any conditions of approval imposed by the EC shall be adhered to.
EC Approval. The Study shall not commence until the Sponsor has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for use; the Protocol; and the participation of Institution and any Research Personnel in the Study and this approval will not be submitted to the Institution. All modifications to the Protocol shall be made by the Sponsor and shall not be implemented by any Investigator until Sponsor provide them any necessary FDA or EC approvals. Modifications to the Informed Consent shall be agreed upon by the Sponsor and the Principal Investigator, and shall not be implemented by any Investigator until receipt of EC written approval. The Parties agrees that any conditions of approval imposed by the EC shall be adhered to. The Sponsor is responsible for fulfilling the legal obligations required of a Sponsor in a clinical trial in relation to SÚKL and the EC or to other regulatory authorities, including, , notification of the commencement and termination of the clinical trial, submission of the reports and reporting of adverse events, notification of new facts and taken measures , and other information obligations, as well as approval of the Informed Consent and its amendments, the approval of Protocol amendments.
EC Approval. The Study shall not commence until Institution has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for use; the 3.1
EC Approval. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorization from the Ethics Committee (“EC”) and competent authorities for the conduct of the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Institution and Principal Investigator to apply for the Clinical Trial Authorization, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of ethics committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions. The Principal Investigator shall not consent to any change in the Protocol requested by an Ethics Committee or competent authority without the prior written consent of the Sponsor. The Institution and/or Principal Investigator shall provide SynteractHCR and Sponsor with written confirmation of the EC’s approval prior to the enrollment of any Study subjects in the Study. If the EC withdraws approval of the Study at any time, the Institution and/or Principal Investigator shall immediately notify Sponsor in writing and concurrently provide a written explanation of the circumstances leading to such withdrawal. In such event Sponsor may terminate this Agreement by written notice to the Institution and the Principal Investigator effective immediately upon delivery.
EC Approval. The Principal Investigator shall: 3.3
EC Approval. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorization from the Ethics Committee (“EC”) and competent authorities for the conduct of the Clinical Trial and substantial amendments to the Protocol. The Sponsor will apply for the Clinical Trial Authorization, in which case the Sponsor shall keep the Healthcare Provider fully apprised of the progress of ethics committee submissions and shall upon request provide the Healthcare Provider with all correspondence relating to such submissions. The Sponsor shall provide the Healthcare Provider with written confirmation of the EC’s approval prior to the enrollment of any Study subjects in the Study. If the EC withdraws approval of the Study at any time, the Sponsor shall immediately notify Healthcare Provider in writing and concurrently provide a written explanation of the circumstances leading to such withdrawal. In such event Sponsor may terminate this Agreement by written notice to the Healthcare Provider effective immediately upon delivery.
