Conduct of Study Sample Clauses

Conduct of Study. Protocol 1.1

Conduct of Study. Subject to approval of the Study as described herein, Institution, through the Investigator, agrees to conduct the Study in strict compliance with the Protocol, this Agreement and any amendments thereto, any and all applicable federal, state, and local laws, regulations, good clinical practices, all reasonable written instructions of the Sponsor or its designee (e.g. CRO) and any other relevant professional standards, with the prior approval and ongoing review of all appropriate and necessary review authorities, including the IRB. Investigator also agrees specifically to conduct the Study in accordance with the Statement of Investigator, FDA Form 1572 (or Investigator Agreement for medical device studies), which Investigator has completed, signed, and delivered to Sponsor prior to the commencement of the Study at the Investigator’s site. Sponsor shall comply with all-applicable federal, state and local laws and regulations in the performance of its activities relating to the Study, and shall obtain all approvals and consents required in connection with such activities. Sponsor shall conduct such Study-related activities in a manner consistent with the informed consents and all other applicable consents. The Institution and Investigator each further agrees that in the performance of the Study, they shall: (a) Exercise independent medical judgment as to the compatibility of each Study participant with Protocol requirements (applicable to Investigator only); (b) ▇▇▇▇▇▇ a signed informed consent form (in a form approved by Sponsor) from each Study participant or his/her legally authorized representative and his/her caregiver in accordance with the Protocol, which has been approved by the IRB and Sponsor in accordance with 21 CFR §56, et. seq., or any successor thereto; (c) Properly perform and direct or administer the Study in accordance with the Protocol, the applicable laws and regulations, the guideline published by the U.S. Food and Drug Administration (“FDA”) entitled, “Good Clinical Practices, Consolidated Guideline” as amended from time to time, and the other requirements as set forth therein, including ISO 14155:2020 for medical device studies, if applicable; (d) Review all Study participant case report forms (hereinafter “CRFs”) to assure their accuracy and completeness, and assist Sponsor’s representatives and clinical monitors upon request in promptly resolving any discrepancies or errors on CRFs and in performing random audits of original patient r...

Conduct of Study. 2.2.1 The Parties shall conduct the Study in accordance with the Protocol and its amendments, the terms of this Agreement, and the terms and conditions of the approval of relevant authorities. 2.2.2 Institution/Principal Investigator shall adhere to separate manuals and specific procedures provided by Sponsor applicable for conducting the Study. 2.2.3 Institution/Principal Investigator shall be fully informed of the Protocol and the Study Product and attend, or ensure a delegate attends, all Investigators’ meetings for the Study from time to time as reasonably required by Sponsor. 2.2.4 Institution/Principal Investigator shall ensure that all the Institution's employees and collaborators, who are involved in the Study fully, understand and adhere to the Protocol and the obligations of both the Institution and the Principal Investigator. 2.2.5 Sponsor shall provide all relevant clinical pharmacology and toxicology information and advice to Institution/Principal Investigator, which are required for the proper planning and conduct of the Study. Such information will include the Investigator's Brochure (IB) and information on Suspected Unexpected Serious Adverse Events (SUSARs) for unlicensed products or the Summary of Product Characteristics (SPC ) for licensed products.

Conduct of Study a) The Institution hereby agrees to conduct the Study in accordance with this Agreement and the Protocol. The Institution shall also follow the Sponsor’s and PSI’s instructions as they relate to the Institution’s and/or the Investigator’s performance under this Agreement. Should there be any inconsistency between the Protocol and the terms of this Agreement, the terms of the Protocol shall prevail for the interpretation of scientific matters and the terms of this Agreement shall prevail for all other matters. b) The Study shall be conducted at the Institution. The Institution shall ensure that the Investigator and all individuals and entities that perform any portion of the Study under the Investigator's supervision (the “Study Personnel”) conduct the Study in compliance with this Agreement. Further, the Institution shall ensure that the Investigator and all Study Personnel are trained on the Protocol and good clinical practices. c) The Institution shall conduct the Study as soon as all of the following events have occurred: (i) the Protocol and the Study have been approved by the responsible ethics committee(s) and the competent authority(ies); (ii) CRFs (as defined below) and the 1.1. Provádění Studie a) Zdravotnické zařízení se tímto zavazuje, že provede Studii v souladu s touto Smlouvou a Protokolem. Zdravotnické zařízení má též povinnost řídit se pokyny PSI a/nebo Zadavatele týkajícími se plnění Zdravotnického zařízení a/nebo Hlavního zkoušejícího vyplývajícího pro ně z této Smlouvy. V případě rozporu mezi Protokolem a podmínkami této Smlouvy mají podmínky Protokolu přednost v odborných záležitostech a podmínky této Smlouvy mají přednost ve všech ostatních záležitostech. b) Studie bude provedena ve Zdravotnickém zařízení. Zdravotnické zařízení má povinnost zajistit, aby Hlavní zkoušející a všechny fyzické i právnické osoby podílející se na provádění Studie pod dohledem Hlavního zkoušejícího (dále jen „Studijní personál“) prováděly Studii v souladu s touto Smlouvou. Zdravotnické zařízení dále zajistí, aby Hlavní zkoušející a veškerý Studijní personál byl vyškolen ohledně Protokolu a správné klinické praxe. c) Zdravotnické zařízení má povinnost provést Studii, jakmile budou splněny všechny následující podmínky: (i) Protokol a Studie byly schváleny příslušnými etickými komisemi a příslušnými úřady,

Conduct of Study. The Site shall, and shall ensure that its employees and agents shall, conduct the Study in strict compliance with any and all applicable federal, national, state, local or other jurisdictional laws, rules, regulations, policies, guidelines, guidances, and governmental requirements, as may be applicable to the Parties, Study Personnel, and/or the Study (“Applicable Law”), including without limitation: i. all applicable rules, policies, or guidance issued by the European Medicines Agency (“EMA”); ii. the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Guidelines for Good Clinical Practices as adopted or issued by any governmental or other regulatory authority, including FDA and EMA (collectively, “GCP” or “GCP Guidelines”), iii. all applicable laws and regulations regarding the protection of privacy, personal data, and medical data, including the European Data Protection Directive (95/46/EC) (collectively, the “Privacy Regulations”); iv. all applicable state HIV testing laws; v. all applicable local,

Conduct of Study. The Study Site and Principal Investigator agree to devote their best efforts to accurately and efficiently perform the work required under this Agreement, which efforts shall include but are not limited to the following: 4. Provádění studie. Studijní pracoviště a hlavní zkoušející souhlasí s ▇▇▇, že vyvinou své maximální úsilí za účelem přesného a efektivního provedení prací vyžadovaných touto smlouvou, přičemž toto úsilí bude zahrnovat zejména následující: A. The Study will be performed in strict accordance with all applicable international and local laws and regulations, institutional guidelines and the Protocol. A properly executed Informed Consent Form, approved by DSI and the Study Site’s Ethics Committee for Multicentric Trials (“ECMT”) and Local Ethics Committees (“LEC”), jointly Ethics Committees (“EC”), which complies with such laws and regulations, shall be obtained from all subjects entered into the Study. Additionally, Study Site and Principal Investigator agree to ensure that patient enrolment does not commence until this Agreement is effective. A. Studie bude provedena v přísném souladu se všemi příslušnými mezinárodními a místními zákony a předpisy, vnitřními směrnicemi studijního pracoviště a protokolem. Řádně vyhotovený formulář informovaného souhlasu schválený společností DSI a etickou komisí pro multicentrická klinická hodnocení („EKMKH“) studijního pracoviště a místními etickými komisemi („MEK“), společně označované jako etické komise („EK“), který je v souladu s těmito zákony a předpisy, bude získán od všech pacientů, kteří vstoupí do studie. Studijní pracoviště a hlavní zkoušející ▇▇▇▇ souhlasí s ▇▇▇, že zajistí, ▇▇▇ ▇▇▇▇▇ pacientů nebyl zahájen dříve, než tato smlouva vstoupí v účinnost. B. The Study shall be conducted in strict compliance with generally accepted standards B. Studie bude prováděna za přísného dodržování všeobecně uznávaných ▇▇▇▇▇ of good clinical research and medical practices, and in compliance with all applicable laws and regulations pertaining to the administration of drugs, the conduct of clinical investigations, the retention of records, the non-use of specific patient names on clinical report forms, and other guidelines and laws pertaining to patient confidentiality, including but not limited to all applicable Czech laws and regulations, in particular Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to some related acts (“Act on Pharmaceuticals”) and Decree No. 226/2008 Coll., on good clinical pract...

Conduct of Study. Protocol 1.1 Realizácia Štúdie/Protokol a) The Institution hereby agree to conduct the Study in accordance with this Agreement and the Protocol.

Conduct of Study. 301 The study will be conducted jointly by the association and the district. Results will be approved by the parties within fifteen (15) working days of completion of the study.

Conduct of Study. The contractor agrees to perform a study (the "Study") of the test kit (the "Test Kit") as described in the study protocol attached to this Agreement as Exhibit A (the "Protocol"), subject to the terms and conditions of this Agreement, including those attached to this Agreement as Exhibit B, and in a manner consistent with the most current Good Laboratory Practices Standards and requirements, or other governmental agencies which have jurisdiction over Contractor's laboratory facility or the Study. The Protocol may not be modified except by agreement between Contractor and Sponsor, which agreement must be in writing. Contractor shall, in any event, promptly notify Sponsor in writing of any such emergency change that has been agreed to by Contractor and Sponsor. If, during the Study, Sponsor and Contractor develop additional protocols or changes to the Protocol that are to govern the conduct of the Study, Sponsor and Contractor shall execute an addendum to Exhibit A stating the terms of the changes to the Protocol or such additional protocol.