Conduct of the Trial. 2.1 UCL and CTC shall undertake the Trial as Sponsor according to the approved Protocol, the Regulations, GCP and any other applicable local laws and regulations.
Conduct of the Trial. 1.1 The INSTITUTION and INVESTIGATOR each agree to perform the clinical trial in strict accordance with the protocol entitled, “ .” STUDY, dated 29 May 2014, which vlastní know-how a technické informace o takových produktech a prostředcích. VZHLEDEM K TOMU, ŽE ZADAVATEL najalklinickou výzkumnou organizaci Pharmaceutical Research Associates International („CRO”), aby jednala jako nezávislý dodavatel, ale ne jako strana této SMLOUVY, jménem ZADAVATELE za účelem provedení určitých aspektů úkolů ZADAVATELE uvedených níže, jako například splnění SMLOUVY, zaplacení, monitorování a/nebo jiné činnosti v rámci STUDIE; a VZHLEDEM K TOMU, ŽE společnost UCB BIOSCIENCES, INC. je jmenována ZADAVATELEM STUDIE (jak je definováno níže) a delegovala odpovědnost za provádění takové STUDIE na svoji SESTERSKOU SPOLEČNOST UCB BIOSCIENCES GMBH která xx xxxx označována jako ZADAVATEL pro účely této SMLOUVY; a VZHLEDEM K TOMU, ŽE si ZADAVATELpřeje zmocnit INSTITUCI k organizování a provedení („STUDOVANÝ LÉK“). („STUDIE“); a VZHLEDEM K TOMU, ŽE ŘEŠITEL jezaměstnán INSTITUCÍ a bude působit jako ŘEŠITEL pro STUDII (definováno výše); a VZHLEDEM K TOMU, ŽE INSTITUCE aŘEŠITEL přezkoumali dostatečné množství informací týkajících se STUDOVANÉHO LÉKU a PROTOKOL (definováno níže) pro vyhodnocení jejich zájmu o účast na STUDII. PROTO NYNÍ STRANY v úmyslu být právně vázány uzavřely tuto SMLOUVU a domluvily se zvláště na následujícím: 1. PROVEDENÍ HODNOCENÍ 1.1 INSTITUCE a ŘEŠITEL se zavazují každý zvlášť provést klinické hodnocení v přísném souladu s protokolem pod názvem „“ STUDIE , ze dne 29 května
Conduct of the Trial. 2.1. The Trial is an intergroup trial in which Coordinating Centre is the lead coordinating group of the Trial. Coordinating Centre has delegated certain activities and functions to ------------- Partner. Each shall undertake the Trial in their respective countries as set down in the Protocol and the Roles and Responsibilities Table;
Conduct of the Trial. 1.1. SAKK shall undertake the Trial as the respective “Legal Sponsor” (hereinafter the “Sponsor”) of the Trial as set down in the Protocol, which is independently developed by the Investigators, attached to this Agreement and incorporated by reference (Appendix 1: Protocol).
Conduct of the Trial. The parties shall conduct the Trial on or before the date agreed upon.
Conduct of the Trial. The Institution, through the applicable Principal Investigator and Sub- investigators, shall use reasonable efforts to conduct each Trial in accordance with this Agreement, the applicable SOW, the applicable Protocol, and the applicable investigator’s brochure for the Protocol (the “Investigator’s Brochure”), as each may be amended, and all applicable United States laws, rules, regulations and guidelines, as adopted into law relating to the conduct of clinical investigations, good clinical practice (GCP) principles, generally accepted medical practice, and applicable export control rules and regulations (collectively, “Applicable Laws”). For purposes of this Agreement, the term “Institution” shall include all employees, executives, officers, directors, faculty, staff and other authorized agents of the Institution. SPONSOR will use reasonable efforts to perform its applicable obligations in connection with each Trial including, but not limited to, monitoring visits. Initiation of a Protocol under a SOW shall not begin until IRB (defined in Section 6.2) approval is obtained. SPONSOR and Institution shall consider each Trial under a respective SOW to be complete and concluded at all sites at such time as the occurrence of final data lock or earlier termination by a Data Safety Monitoring Board (“Trial Conclusion”). Sponsor shall conduct its obligations under this Agreement and each Trial in accordance with Applicable Laws.
Conduct of the Trial. Institution shall, and shall cause Principal Investigator and all Institution Personnel to, diligently perform the Trial in accordance with (i) the Protocol, (ii) Applicable Law, (iii) Sponsor’s or its designee’s written instructions and (iv) Institution’s internal policies (which policies Institution represents and warrants are not inconsistent with any of the foregoing). For purposes of this Agreement, “Applicable Law” shall mean all applicable laws, rules, and regulations pertaining to the activities contemplated herein, including without limitation, Directive 2001/20/EC, as implemented in the Czech Republic and as replaced by the CTR as soon as applicable, and Regulation (EU) 2016/679 of 2.1
Conduct of the Trial. The Sponsor and the CI shall undertake the Trial according to the approved Protocol, the Regulations, GCP (which, for clarity, refers to the principles of ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) as set out in Schedule 1 (Conditions and Principles of Good Clinical Practice and for the Protection of Clinical Trial Subjects) of the Medicines for Human Use (Clinical Trials) Regulations 2004 and the GCP Directive 2005/28/EC, as set out in SI 2006/1928, and any amendments thereto), and any local laws and regulations applicable to clinical trials and the care of clinical trial subjects. The Trial shall be conducted by the CI: In all participating site(s) selected by the CI, with Sponsor oversight of site feasibility requirements; In accordance with the approved Protocol and any amendment/ modifications to the Protocol (unless urgent safety measures are deemed necessary); In accordance with the terms of the clinical trial authorisation (CTA) granted by the regulatory authority (MHRA); In accordance with the terms and conditions of the [REC]/[GTAC](delete what is not applicable) approval given to the Trial; In accordance with the relevant safety reporting provisions, as further described in this Agreement and the approved Protocol. In accordance with the applicable Sponsor SOPs for CTIMPs as amended from time to time and available on the JRO web site. The Parties acknowledge that the CI is expected to comply with their obligations under this Agreement as of its effective date in accordance with clause 4.1. Notwithstanding the foregoing, the CI is expected to comply with as many obligations as possible if the Trial has been set up prior to the effective date of this Agreement. The Parties shall comply with all UK laws and statutes applicable to the performance of clinical trials including, but not limited to, the Human Rights Act 1998, the Data Protection Act 1998, The Freedom of Information Act 2000, EU Regulations on Advanced Therapy Medicinal Products (delete if not an ATMP Trial), The EU Tissues and Cell Directive (delete if not an ATMP Trial involving procurement of tissues or cells), The Human Tissue Act 2004, the Regulations (as previously defined), GMP (which, for clarity, refers to refers to European Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, and any amendm...
Conduct of the Trial. 2. Provádění studie.
Conduct of the Trial
