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 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.
2.2 The Trial shall be conducted by the Parties:
2.2.1 At the Site and in accordance with the terms of this Agreement;
2.2.2 In accordance with the Protocol and any amendments to the Protocol;
2.2.3 With Trial Subjects selected in accordance with the criteria specified in the Protocol;
2.2.4 Only after all necessary legal, regulatory and/or other approvals have been granted including, without limitation, REC approval, Clinical Trial Authorisation granted by the MHRA and NHS permission (Health Research Authority approval in England) and strictly in accordance with the terms of any of such approvals.
2.3 The Parties shall comply with all guidance, laws and statutes applicable to the performance of clinical trials including, but not limited to, the Human Rights Xxx 0000, Data Protection Legislation, The Freedom of Information Xxx 0000, The Human Tissue Xxx 0000, the Medicines Xxx 0000, the Regulations, GMP, and with all relevant guidance relating to medicines and clinical trials from time to time in force including, but not limited to, GCP, the World Medical Association Declaration of Helsinki entitled 'Ethical Principles for Medical Research Involving Human Subjects' (1996 version), the Framework and any amendments thereto.
2.3.1 In addition to clause 2.3 above, Scottish, Welsh and Northern Irish Sites shall comply with all their local laws and statutes applicable to the performance of clinical trials.
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).
1.2. SAKK is solely responsible for the compliance with clinical and/or regulatory procedures associated with the conduct of the Trial.
1.3. SAKK will ensure that all investigators and personnel who participate in the conduct of the Trial are informed of, trained and abide by all applicable terms of this Agreement.
1.4. The Trial shall be conducted by SAKK:
1.4.1. in accordance with the Protocol and any amendments to the Protocol;
1.4.2. at the Sites participating in the Trial selected by SAKK;
1.4.3. with patients selected in accordance with, and who meet the criteria specified in the Protocol;
1.4.4. only after all necessary legal, regulatory or other approvals have been granted including, without limitation, those of any Institutional Review Board / Independent Ethics Committee at the Site and strictly in accordance with the terms of any such approval;
1.4.5. in accordance with the Declaration of Helsinki and with the principles of good clinical practice as laid down by the ICH topic E6: ‘Good Clinical Practice: Consolidated Guideline’, the Swiss Human Research Act of 30 September 2011 (HRA) in connection with the Swiss Ordinance about Clinical Trials in Human Research of 20 September 2013 (ClinO) and all applicable local regulations for Switzerland and other participating countries in EU (if any);
1.4.6. SAKK shall be entitled to make changes to the Protocol and shall notify Partner in writing before implementation of any such change, provided, however, that no Material Change (as hereinafter defined) to the Protocol shall be made unless approved by Partner in writing in advance. For purposes of this Section ”Material Change” shall mean any change to the Protocol which (a) affects the administration of the Trial Drug (e.g., dosage, duration of therapy, application, etc.) or (b) could have an impact on the labeling of the Trial Drug or (c) would change the time schedule of the Trial.
Conduct of the Trial. 2. Provádění studie.
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;
2.2. The Trial shall be conducted by Coordinating Centre. ------------- Partner will not make decisions independent of the Coordinating Centre. Coordinating Centre will retain the authority to make decisions independent of the ------------- Partner:
a. In accordance with the Protocol and any amendments to the Protocol as approved by the Executive Committee, the Coordinating Centre and by the main Research Ethics Boards at the ------------- Partner Site;
b. Participating Centres to be selected by ------------- Partner;
c. With Trial participants selected in accordance with the eligibility criteria specified in the Protocol and only after all necessary legal, regulatory or other approvals (if needed) have been granted including those of the Institutional Review Board or of any ethics committee,at the Participating Centres and strictly in accordance with the terms of any such approval;
d. In accordance with the Declaration of Helsinki 1996, and with the principles of GCP;
e. In accordance with the requirements laid down by applicable law in the countries where the Trial is conducted, including but not limited to PIPL and the Data Security Law (“DSL”) of the ----------- (Country).
2.3. In accordance with applicable data protection legislation, the party processing data on behalf of the other agrees the signature of this Agreement serves as prior agreement of the party acting as the data processor of the other party to store or process Personal Data at sites outside of ----------. The Parties shall comply with the requirements of the common law of confidentiality, the Data Protection Act 1998 and, as appropriate.
2.4. Personal data shall not be disclosed to the Coordinating Centre by the ------------- Partner, save where this is required directly or indirectly to satisfy the requirements of the Protocol, or for the purpose of monitoring or reporting adverse events.
2.5. The Parties shall use their best efforts to complete the Trial and to perform their obligations under this Agreement. The Parties offer no guarantee that a particular result will be obtained or that the result of the work may be used for a specific purpose.
2.6. The...
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 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. 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. The parties shall conduct the Trial on or before the date agreed upon.
Conduct of the Trial.
3.1 The Institution guarantees that the Trial (i) conforms to the provisions established in the Protocol and no amendment thereto shall be valid without the prior written consent of both Parties and (ii) shall be carried out in strict compliance with the rules applicable to this type of clinical trial.
3.2 VCN shall provide the Hospital, when the latter so requests in writing and at no cost to the Hospital, the quantities of the Product that the Hospital needs to conduct the Trial, in the manner and within the periods agreed by and between the Parties at any given time.
3.3 VCN guarantees that the manufacture and supply of the Products will be carried out in accordance with the regulations applicable to this type of product, including but not limited to the Good Manufacturing Practices (GMP) in force at all times.
3.4 In addition, VCN undertakes to perform, at its own expense, all additional studies that are necessary to include the Product in the Trial.
3.5 Attached as Annex II to this Agreement is a detail of the different obligations that each of the Parties assumes for the preparation and execution of the Trial.
