CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, 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 the Ethics Committee or Competent Authority without the prior written consent of the Sponsor. In the event of any substantial amendments being made to the Protocol, the amendments shall be signed by the Principal Investigator and shall be implemented by the Research Staff as required by the Sponsor or CRO after approval of the amendments by the Competent Authority and a favourable opinion of the Ethics Committee. The Clinical Trial shall be performed at the Trial Site. The Principal Investigator shall be responsible for obtaining authorization from the representatives of the Trial Site to perform the Clinical Trial at the Trial Site, which shall include but not be limited to the engagement of sub-investigators, to the extent applicable the pharmacist of the Institution (unless a separate Pharmacy Agreement is made as set out in article 7.1 below), clinical chemists, and the Research Staff required to perform the Clinical Trial as set out in this Agreement. The Sponsor shall submit the Clinical Trial for listing on a free, publicly accessible clinical trial registry like xxx.xxxxxxxxxxxxxx.xxx or on websites managed by a registry conforming to WHO standards (xxxx://xxx.xxx.xxx/ictrp/network/criteria_summary/en/index.html) after Clinical Trial Authorization. Upon request of the Institution or the Principal Investigator the Sponsor will disclose the registry and the date of submission. The Parties shall conduct the Clinical Trial in accordance with: the Agreement; the Protocol; the terms and conditions of the Clinical Trial Authorisation granted by the Competent Authority and the opinion of the Ethics Committee; and the applicable Law. The Site Parties shall make and retain records regarding the Clinical Trial as required by the Protocol, applicable Law, and in accordance with the Institution’s standard archiving procedures. Institution will retain such records for a minimum of fifteen (15...
CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. 3.1. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, 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.
CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. 3.1. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol.
