Regulatory and Ethical Considerations Sample Clauses

Regulatory and Ethical Considerations. Regulatory Authority Approval This study will be conducted in accordance with Good Clinical Practice (GCP) requirements described in the current revision of International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidelines and all applicable regulations, including current United States Code of Federal Regulations (CFR), Title 21, Parts 50, 54, 56, and 312 and Title 45, Part 164. Compliance with these regulations and guidelines also constitutes compliance with the ethical principles described in the current revision of the Declaration of Helsinki. This study will also be carried out in accordance with local legal requirements. Ethics Approval It is the Investigator’s responsibility to ensure that, prior to initiating the study, this protocol is reviewed and approved by the appropriate local IRB/IEC. A non-local IRB/IEC may be used if the site of the study is not under the auspices of an IRB/IEC. The IRB/IEC must also review and approve the site’s informed consent form (ICF), other written information provided to the subject and all advertisements that may be used for subject recruitment. The Investigator will provide the Sponsor or designee with copies of these documents and of dated IRB/IEC approval(s) prior to the start of the study. If it is necessary to amend the protocol or the ICF during the study, the Investigator will be responsible for ensuring that the IRB/IEC reviews and approves these amended documents. An IRB/IEC approval of the amended protocol and/or ICF must be obtained before implementation of the amended procedures and before new subjects are consented to participate in the study using the amended version of the ICF. The Investigator will forward copies of the dated IRB/IEC approval of the amended protocol and/or ICF to the sponsor or designee as soon as available. Subject Informed Consent Before being admitted to the clinical study, all subjects must consent to participate. An ICF will be given to each subject, which will contain all US federally required elements, all ICH-required elements, and Health Insurance Portability and Accountability Act Authorization (HIPAA) information in language that is understandable to the subject. In addition, for those subjects who are 12-17 years old and are legally unable to sign an informed consent form, an IRB-approved assent form will be provided. The consent should note that the Investigator is receiving compensation for the expenses of conducting ...
Sample 1
AutoNDA by SimpleDocs
Regulatory and Ethical Considerations. This study will be conducted in accordance with the protocol and with the following: - Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines - Applicable ICH/ISO Good Clinical Practice (GCP) guidelines - Applicable laws and regulations • The protocol, protocol amendments, ICF, Investigator’s Brochure, and other relevant documents (eg, advertisements) must be submitted to an IRB/IEC by the Investigator and reviewed and approved by the IRB/IEC before the study is initiated. • Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study subjects. • The Investigator will be responsible for the following: - Providing written summaries of the status of the study to the IRB/IEC annually or more frequently in accordance with the requirements, policies, and procedures established by the IRB/IEC - Notifying the IRB/IEC of SAEs or other significant safety findings as required by IRB/IEC procedures - Providing oversight of the overall conduct of the study at the site and adherence to requirements of applicable local regulations, for example 21 Code of Federal Regulations (CFR), ICH guidelines, the IRB/IEC, and European regulation 536/2014 for clinical studies (if applicable)
Sample 1
Regulatory and Ethical Considerations. This study will be conducted in accordance with the protocol and with the following: ● Consensus ethical principles derived from international guidelines including the Declaration of Helsinki ● Applicable ICH Good Clinical Practice (GCP) Guidelines ● Applicable laws and regulations The protocol, protocol amendments, ICF, and other relevant documents (eg, advertisements) must be submitted to an IRB/IEC by the investigator and reviewed and approved by the IRB/IEC before the study is initiated. Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study participants. The investigator will be responsible for the following: ● Providing written summaries of the status of the study to the IRB/IEC annually or more frequently in accordance with the requirements, policies, and procedures established by the IRB/IEC ● Notifying the IRB/IEC of SAEs or other significant safety findings as required by IRB/IEC procedures; and ● Providing oversight of the conduct of the study at the site and adherence to requirements of 21 CFR, ICH guidelines, the IRB and all other applicable local regulations
Sample 1
Regulatory and Ethical Considerations. This clinical study was designed and shall be implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC and US Code of Federal Regulations (CFR) Title 21), and with the ethical principles that originate from the Declaration of Helsinki. The protocol and the proposed ICF(s) must be reviewed and approved by a properly constituted IRB/IEC before study start. Prior to study start, the Investigator is required to sign a protocol signature page confirming his/her agreement to conduct the study in accordance with these documents and all of the instructions and procedures found in this protocol and to give access to all relevant data and records to Karyopharm monitors, auditors, designated agents of Karyopharm, IRBs/IECs, and regulatory authorities as required. Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study patients.
Sample 1
Regulatory and Ethical Considerations 
Sample 1

Related to Regulatory and Ethical Considerations

  • Ethical Conduct Seller's employees shall comply with the BorgWarner Supplier Code of Conduct articulated within the BorgWarner Supplier Manual. Compliance with these standards is a mandatory component of Buyer's purchase contracts worldwide and must also apply to Seller subcontractors. Both, the BorgWarner Supplier Code of Conduct and the BorgWarner Supplier Manual are incorporated by reference as part of the Purchase Order, are binding on the Seller, and Seller explicitly verifies to have read and accepted the BorgWarner Supplier Code of Conduct and the BorgWarner Supplier Manual.

  • Fitness for Duty Examination A. In directing employees to undergo a fitness for duty examination, the Agency will observe applicable rules and regulations.

  • Conflict of Interest; Governmental Conduct Act A. The Contractor represents and warrants that it presently has no interest and, during the term of this Agreement, shall not acquire any interest, direct or indirect, which would conflict in any manner or degree with the performance or services required under the Agreement.

  • Responsibilities and Restrictions Concerning Governing Body, Officers and Employees Grantee and its governing body will:

  • Compliance with Executive Orders Concerning Ethics The Contractor warrants that he and his firm have complied in all respects with the Governor’s Executive Orders concerning ethics matters, including, but not limited to, Executive Order dated January 13, 2003 (establishing Code of Ethics for Executive Branch Officers and Employees, including provisions governing former officers and employees); Executive Order dated October 1, 2003 (governing vendors to state agencies and disclosure and registration of lobbyists); and O.C.G.A. Sections 21-5-70(5), 21-5-71 and 21-5-73, all as amended effective January 9, 2006 (requiring registration and disclosure filings by state agency vendor lobbyists). In this regard, the Contractor certifies that any lobbyist employed or retained by the Contractor or his firm has both registered and made the required disclosures required by the Executive Orders, as amended.

  • Certification Regarding Lobbying Applicable to Grants Subgrants, Cooperative Agreements, and Contracts Exceeding $100,000 in Federal Funds Submission of this certification is a prerequisite for making or entering into this transaction and is imposed by section 1352, Title 31, U.S. Code. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. The undersigned certifies, to the best of his or her knowledge and belief, that: (1) No Federal appropriated funds have been paid or will be paid by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of congress, or an employee of a Member of Congress in connection with the awarding of a Federal contract, the making of a Federal grant, the making of a Federal loan, the entering into a cooperative agreement, and the extension, continuation, renewal, amendment, or modification of a Federal contract, grant, loan, or cooperative agreement. (2) If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of congress, or an employee of a Member of Congress in connection with this Federal grant or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, “disclosure Form to Report Lobbying,” in accordance with its instructions. (3) The undersigned shall require that the language of this certification be included in the award documents for all covered subawards exceeding $100,000 in Federal funds at all appropriate tiers and that all subrecipients shall certify and disclose accordingly. I HAVE NOT Lobbied per above If you answered "I HAVE lobbied" to the above Attribute Question If you answered "I HAVE lobbied" to the above Attribute question, you must download the Lobbying Report "Standard From LLL, disclosure Form to Report Lobbying" which includes instruction on completing the form, complete and submit it in the Response Attachments section as a report of the lobbying activities you performed or paid others to perform. Subcontracting with Small and Minority Businesses, Women's Business Enterprises, and Labor Surplus Area Firms. Do you ever anticipate the possibility of subcontracting any of your work under this award if you are successful? IF NO, DO NOT ANSWER THE NEXT ATTRIBUTE QUESTION. . IF YES, and ONLY IF YES, you must answer the next question YES if you want a TIPS Member to be authorized to spend Federal Grant Funds for Procurement. NO

  • RESPONSIBILITIES OF THE UNIVERSITY 1. The UNIVERSITY shall designate in writing a faculty member to coordinate with a designee of the FIELDWORK SITE.

  • Knowledge and Scholarship in Special Field Each certificated support person demonstrates a depth and breadth of knowledge of theory and content in the special field. He demonstrates an understanding of a knowledge about common school education and the educational milieu grades K12, and demonstrates the ability to integrate the area of specialty into the total school milieu, to wit:

  • Compliance with Governmental Directives The DS Supplier also acknowledges and agrees that the Company may need to act in response to governmental or civil authority directives which may affect DS Load. The DS Supplier agrees to cooperate with the Company in order to comply with said directives.

  • BUSINESS ETHICS During the course of pursuing contracts, and the course of contract performance, Provider will maintain business ethics standards aimed at avoiding real or apparent impropriety or conflicts of interest. No substantial gifts, entertainment, payments, loans or other considerations beyond that which would be collectively categorized as incidental shall be made to any employees or officials of HISD, its authorized agents and representatives, or to family members of any of them. At any time Provider believes there may have been a violation of this obligation, Provider shall notify HISD of the possible violation. HISD is entitled to request a representation letter from Provider, its subcontractors or vendors at any time to disclose all things of value passing from Provider, its subcontractors or vendors to HISD’s personnel or its authorized agents and representatives. REQUIRED DISCLOSURES

Time is Money Join Law Insider Premium to draft better contracts faster.