Investigator and Institution Sample Clauses

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.
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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: (i) maintain and store Medical Records including the list of Subject’s identification codes and Study Results in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Applicable Laws, regulations and industry standards; and (ii) protect the Medical Records and Study Results from unauthorized use, access, duplication, and disclosure. If directed by Sponsor by means of CRO or CRO, Institution and Investigator will submit Study Results using the electronic system provided by Sponsor by means of CRO or CRO or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Institution and Investigator shall prevent unauthorized access to the Study Results by maintaining physical security of the electronic system and ensuring that Study Personnel maintain the confidentiality of their passwords. Investigator agrees to collect all Study Results in Medical Records prior to entering it into the eCRF/CRF. Institution and Investigator shall ensure the prompt submission of eCRFs/CRFs; and (iii) take measures to prevent accidental or premature destruction or damage of these documents, for as long as agreed herewith. 2.10 a) The Medical Records and Study Data shall be retained for a minimum of twenty five (25) years from the Institution´s close out visit or for the duration required by Applicable Law, whichever is longer. In compliance with Sponsor’s obligations under ICH GCP, Sponsor shall notify the Institution in writing if the Medical Records and Study Data are no longer needed before the completion of the minimum retention period agreed herewith. If the Institution has not been notified by Sponsor otherwise before the completion of the minimum retention period, then after the completion of the minimum retention period the Institution can destroy or permit the destruction of the Medical Records and Study Data. Any inquiries or requests regarding record retention can be sent at any time during the retention period to the email address xxxxxxx@xxxxxxxxxx.xxx, but in no circumsta...
Sample 1See All (5)
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);
Sample 1Sample 2Sample 3
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. 3.2 The Institution and the Investigator shall recruit and ensure the performance of the obligations of the Study Staff as set out in this Agreement. 3.3 The Institution and the Investigator shall be responsible and liable for the acts and omissions of their own employees and Agents in connection with the Clinical Study, as if such acts and omissions were those of the Institution or the Investigator. 3.4 The Institution and the Investigator represent and warrant that they are not currently using, and shall not knowingly use the services of any person, including the Investigator, who is debarred, proposed for debarment or otherwise disqualified or suspended from performing a clinical study or otherwise subject to any restrictions or sanctions by any Regulatory Authority or EC with respect to the performance of scientific or clinical investigations. The Institution and the Investigator will immediately notify Sponsor if either of them becomes aware of any such debarment, proposal for such debarment, disqualification or suspension.
Sample 1
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 : (i) maintain and store Medical Records and Study Results in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Applicable Laws, regulations and industry standards; and (ii) protect the Medical Records and Study Results from unauthorized use, access, duplication, and disclosure. If directed by Sponsor or CRO, Institution and Investigator will submit Study Results using the electronic system provided by Sponsor or CRO or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Institution and Investigator shall prevent unauthorized access to the Study Results by maintaining physical security of the electronic system and ensuring that Study Personnel maintain the confidentiality of their passwords. Investigator agrees to collect all Study Results in Medical Records prior to entering it into the eCRF/CRF. Institution and Investigator shall ensure the prompt submission of eCRFs/CRFs; and (iii) take measures to prevent accidental or premature destruction or damage of these documents, for as long as agreed herewith.
Sample 1
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.
Sample 1
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
Sample 1
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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. 2.2 The Institution and the Investigator shall recruit and ensure the performance of the obligations of the Trial Site Team Members as set out in this Agreement. 2.3 The Institution and the Investigator shall be responsible and liable for the acts and omissions of their own employees and Agents in connection with the Clinical Trial, as if such acts and omissions were those of the Institution or the Investigator. 2.4 The Institution and the Investigator represent and warrant that they are not currently using, and shall not knowingly use the services of any person, including the Investigator, who is debarred, proposed for debarment or otherwise disqualified or suspended from performing a clinical study or otherwise subject to any restrictions or sanctions by any Regulatory Authority or REB with respect to the performance of scientific or clinical investigations. The Institution and the Investigator will immediately notify Sponsor if either of them becomes aware of any such debarment, proposal for such debarment, disqualification or suspension.
Sample 1

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