Conduct of the Study. The Institution and the Investigator will conduct the Study pursuant to the terms of this Agreement and in strict adherence to the Spectrum protocol designated SPI-1012 and entitled “A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients with Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)” (collectively “Protocol”) as the same may be amended from time to time in writing by Spectrum, and any other written instructions that may be provided from time to time to the Institution. A copy of the Protocol as of the Effective Date is on file with each Party to this Agreement, and is incorporated herein as Exhibit A.
Conduct of the Study. (a) Institution and Investigator represent that it/he/she has the experience, capabilities, equipment, and adequate subject numbers and resources, inter alia, including sufficient appropriately trained personnel with experience in clinical trials and ICH-GCP (“Research Staff”, which term, for the avoidance of doubt shall include all persons who have involvement in the Study and who are employees of the Institution including but not limited to pharmacy, laboratory. radiology and nursing staff) to accurately, efficiently and expeditiously perform the Study in a professional and competent manner and will utilize due diligence and devote the necessary personnel and equipment at all times to perform the Study hereunder in such manner.
Conduct of the Study. 1.1. Compliance with Laws, Regulations, and Good Practices Institution agrees that Institution and Study Staff shall perform the Study at Institution in strict accordance with this Agreement, the Protocol specific procedures and instructions provided by IQVIA and/or Sponsor applicable for conducting the Study, as well as, any and all applicable laws regulations and guidelines, including in particular, but without limitation, GxPs, Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to some related acts (“Act on Pharmaceuticals”), Decree No. 463/2021 Coll., on more detailed conditions for conducting clinical trials of medicinal products for human use, Regulation No. 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC and Act No. 372/2011 Coll., on Medical Services and terms and conditions of performance of such services („Act on Medical Services“) or any subsequent amendments or laws substantially výrobky; pohoštění, zábavu, či pohostinnost; cesty či proplácení nákladů; poskytování služeb; koupě majetku či služeb za nadhodnocené částky; převzetí či prominutí splatných závazků; výhody nehmotného charakteru, jako například zvýšené sociální či podnikatelské postavení (např., poskytování darů či podpory na dobročinné účely, jež jsou podporovány státními/správními úřady); a/nebo výhod vůči třetím osobám vztahující se k zástupcům veřejné moci (např. blízcí členové rodiny). Úvodní část: VZHLEDEM K TOMU, že IQVIA poskytuje Zadavateli služby smluvní výzkumné organizace, a to na základě samostatné smlouvy uzavřené mezi IQVIA a Zadavatelem. Služby IQVIA zahrnují monitoring Studie a uzavírání smluv s klinickými výzkumnými centry VZHLEDEM K TOMU, že Zdravotnické zařízení hodlá provést Studii a IQVIA po Zdravotnickém zařízení požaduje provedení takové Studie. NYNÍ S OHLEDEM NA SHORA UVEDENÉ, bylo dohodnuto následující: 1.