Inspection and Assistance with Regulatory Matters. Kontrola a pomoc při regulačních záležitostech.
Inspection and Assistance with Regulatory Matters. (i) At reasonable times and upon reasonable notice, Gilead and its respective appointed representatives shall have the right to inspect, audit, and monitor the Trial Site, Institution’s facilities, and all records described in Section 2.3. Each of the Institution, Trial Personnel and Investigator will cooperate with Gilead and its appointed representatives with respect to such inspections, audits and monitoring visits.
(ii) Institution and Investigator will notify Gilead immediately upon receiving notice of, and will cooperate with Gilead on any impending inspection or other action related to the Trial by the FDA or other governmental or regulatory authority. Institution and Investigator will promptly provide Gilead with a copy of any documentation relating to the Trial received from or sent to the FDA or any other regulatory authority. Institution and Investigator will cooperate and comply with regulatory agencies with respect to such inspections, audits and monitoring visits.
(iii) At Gilead’s request and expense, Institution and/or Investigator, as appropriate, will assist Gilead in the preparation and submission of investigational new drug applications, new drug applications, and any other pre-market applications relating to the Trial as may be required by the FDA or other regulatory authorities, and will attend meetings with such regulatory authorities regarding such applications.
Inspection and Assistance with Regulatory Matters. 2.4. Kontrola a součinnost v regulačních z áležitostech.
(i) At reasonable times and upon reasonable notice, Sponsor and its respective appointed representatives shall have the right to inspect, audit, and monitor the Study Site, Institution’s facilities, and all records described in Section 2.3. Each of the Institution and Investigator will cooperate with Sponsor and its appointed representatives with respect to such inspections, audits and monitoring visits. (i) V rozumné době a na základě rozumného oznámení budou mít Zadavatel a příslušní jím stanovení zástupci právo ke kontrole, auditu a monitorování Studijního pracoviště, prostor Zdravotnického zařízení a veškerých záznamů popsaných v Oddílu 2.
Inspection and Assistance with Regulatory Matters. (i) At reasonable times and upon reasonable notice, Gilead and its respective appointed representatives shall have the right to inspect, audit, and monitor the Trial Site, Institution’s facilities, and all records described in Section 2.3. Each of the Institution, Trial Site and Investigator will cooperate with Gilead and its
