Investigator and Institution shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records, Study Results and of all clinical supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions. Institution and Investigator shall :
Investigator and Institution acknowledge that CRO is the recipient of Services described in this Agreement and, for the avoidance of any doubt, that SPONSOR is not the recipient of Services described in this Agreement.
Investigator and Institution. 2.1 Investigator represents and warrants that Investigator holds the necessary qualifications and has the necessary expertise, time and resources to conduct the Clinical Trial, and that the terms of this Agreement are not inconsistent with any other contractual or legal obligations that Investigator may have, or with Institution’s policies or procedures, or the policies and procedures of any institution or company with which Investigator is associated. Investigator shall during the Term: (i) remain a member in good standing of the applicable College of Physicians and Surgeons (without any terms, limitations or conditions);
Investigator and Institution. 2.1 The Investigator represents and warrants that he or she holds the necessary qualifications and has the necessary expertise, time and resources to perform the Clinical Trial and that the terms of this Agreement are not inconsistent with any other contractual or legal obligations that the Investigator may have, or with the Institution’s policies or procedures or the policies and procedures of any institution or company with which the Investigator is associated. The Investigator shall through the duration of the Clinical Trial: (i) remain a member in good standing of the applicable College of Physicians and Surgeons or such other health profession regulatory body with which the Investigator is registered or of which the Investigator is a member; (ii) remain a member of the Canadian Medical Protective Association, or have equivalent professional liability insurance coverage; and (iii) immediately notify the other Parties in writing if such status changes during the term of this Agreement.
Investigator and Institution. 2.1 Investigator represents and warrants that Investigator holds the necessary qualifications and has the necessary expertise, time and resources to conduct the Clinical Trial, and that the terms of this Agreement are not inconsistent with any other contractual or legal obligations that Investigator may have, or with Institution’s policies or procedures, or the policies and procedures of any institution or company with which Investigator is associated. Investigator shall during the Term: (i) remain a member in good standing of the applicable College of Physicians and Surgeons (without any terms, limitations or conditions); (ii) remain a member of the Canadian Medical Protective Association, or have equivalent professional liability insurance coverage; and
Investigator and Institution acknowledge that SPONSOR is the sponsor of the Study, and as such is an intended third-party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the SPONSOR's Study- related functions to CRO in compliance with ICH-GCP, sec. 5.2.1. In addition to the foregoing, Investigator and Institution agree that CRO may disclose any and all Information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to SPONSOR. All references to SPONSOR herein (whether in the context of delivery of Information, submission of applications, financial terms, or anything else) derive from SPONSOR’s status as such, as set out by Applicable Law and GCP regulations, and Investigator and Institution agree to all such instances. Investigator and Institution will Fully Cooperate with CRO’s requests relating to SPONSOR. 2.3. Zkoušející a Zdravotnické zařízení berou na vědomí a souhlasí, že ZADAVATEL je sponzorem Klinického hodnocení a že ZADAVATEL na CRO převádí všechny své povinnosti týkající se Klinického hodnocení, které jsou zde uvedeny, a to v souladu se zásadami správné Klinické praxe (ICH-GCP), článek 5.2.1., a z tohoto titulu je pro účely této Smlouvy považován za obmyšlenou stranu. Kromě shora uvedeného, souhlasí Zkoušející a Zdravotnické zařízení s tím, že CRO může zadavateli předávat jakoukoli informaci a/nebo dokumenty týkající se této Smlouvy a/nebo účasti Zkoušejícího či Zdravotnického zařízení v Klinickém hodnocení (včetně, mimo jiné všech hlášení, jiných dokumentů nebo materiálů, které Zkoušející a/nebo Zdravotnické zařízení na základě této Smlouvy poskytli CRO). Veškeré odkazy na ZADAVATELE v této Smlouvě (jak v souvislosti s předáváním informací, podáváním žádostí, finančními podmínkami či jinak) tak vychází ze shora uvedeného statutu ZADAVATELE dle Platných zákonů a zásad správné Klinické praxe a Zkoušející a Zdravotnické zařízení toto berou na vědomí. Zkoušející a Zdravotnické zařízení se zavazují poskytnout CRO plnou součinnost v souvislosti s požadavky týkajícími se ZADAVATELE.
Investigator and Institution. 3.1 The Investigator represents and warrants that he holds the necessary qualifications and has the necessary expertise, time, and resources to perform the Clinical Study and that the terms of this Agreement are not inconsistent with any other contractual or legal obligations that the Investigator may have, or with the Institution’s policies or procedures or the policies and procedures of any institution or company with which the Investigator is associated. The Investigator shall through the duration of the Clinical Study: (i) remain a member in good standing of the applicable College of Physicians and Surgeons or such other health profession regulatory body with which the Investigator is registered or of which the Investigator is a member; (ii) have a professional liability insurance coverage; and (iii) immediately notify the other Parties in writing if such status changes during the term of this Agreement.
