Subject Information and Informed Consent Sample Clauses

Subject Information and Informed Consent. Each subject (or a legally authorized representative) must give written informed consent prior to any new study-specific procedures being conducted. It is the responsibility of the Investigator to ensure written informed consent is obtained from each subject participating in this study after an explanation of the objectives, methods, discomforts and potential risks of the study has been provided. The Investigator (or study personnel) must also explain to each subject that he/she is free to refuse participation in the study or to withdraw from it at any time. Each subject will also be told that his/her records may be examined by competent authorities and authorized persons but that personal information will be treated as strictly confidential and will not be publicly available. The informed consent form must be in accordance with the Declaration of Helsinki, ICH and GCP guidelines, and be approved by the Sponsor and the IRB/IEC. State or local laws may require additional information. Each subject (or his/her legally authorized representative) must sign and be given a copy of the informed consent form. Each subject’s signed informed consent form must be maintained by the Investigator and be readily available for review by the Sponsor (or its designee) or the Regulatory Authorities.
AutoNDA by SimpleDocs
Subject Information and Informed Consent. No investigator may involve a human being as a subject in research unless the Investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An Investigator shall seek such consent only under circumstances that provide the prospective subject or the subject’s legally authorized representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in a language understandable to the subject or representative. The Sponsor or its designated representative will provide the Investigator with a sample consent form. Local and/or institutional requirements may require disclosure of additional information in the informed consent. Any changes to the consent form must be submitted to the sponsor or its designated representative for approval prior to submission to the IRB/IEC. The IRB/IEC must review the consent form for approval/favorable opinion, and a copy of the approved consent form must be submitted to the Sponsor or its designated representative prior to initiation of the study. Before implementing any study procedure, informed consent shall be documented by the use of an IRB/IEC approved written consent form signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy of the signed informed consent will be given to the subject or the subject’s legally authorized representative. The original signed consent must be maintained by the Investigator and available for inspection by the Sponsor, its designated representative, or regulatory authority at any time. Protocol VB-201-079 VB-201
Subject Information and Informed Consent. Institution and Investigator shall ensure that, before the treatment phases of the Study, the nature, significance, implications and risks of the Study are explained in detail to each Study Subject. Prior to each Study Subject’s enrollment in the Study, Institution and Investigator shall obtain from each individual who is to participate as a Study Subject, a properly executed written informed consent agreement (“ICF”), as approved by Rigel and the IEC before such individual is allowed to participate in the Study or any Study procedures are performed. Institution or Investigator shall ensure that the ICF complies in form and content with Applicable Laws and regulations including, GCP and laws governing data protection and privacy, as well as with all terms of the Protocol relevant to the ICF. Institution shall promptly supply Rigel or CRO with a copy of the ICF approved by the IEC and any amendment to the
Subject Information and Informed Consent. The Principal Investigator shall ensure that, prior to the screening and treatment phases of the Study, the nature, significance, implications and risks of the Study are explained in detail to each Study subject. Prior to the subject’s enrolment into the Study, the Principal Investigator shall obtain their written, dated and signed informed consent to participate, as well as consent for the confidential disclosure, processing and transfer of necessary documentation of the subject’s health and personal data to PAREXEL, SPONSOR, the competent health authorities and other institutions (even if located outside of the European Economic Area), as legally required and in accordance with the standards specified in Section 2.1. The Principal Investigator shall explain to all subjects the insurance provisions referenced in Section 7.1 of this Agreement.
Subject Information and Informed Consent. Institution and Investigator shall ensure that, before the screening and treatment phases of the Study, the nature, significance, implications and risks of the Study are explained in detail to each Study Subject. Prior to each Study Subject’s enrollment in the Study, Institution and Investigator shall obtain from each individual who is to participate as a Study Subject, a properly executed written informed consent agreement (“ICF”), as approved by Rigel and the IEC before such individual is allowed to participate in the Study or any Study procedures are performed. Institution or Investigator shall ensure that the ICF complies in form and content with Applicable Laws and regulations including, GCP and laws governing data protection and privacy, as well as with all terms of the Protocol relevant to the ICF. Institution shall promptly supply Rigel or CRO with a copy of the ICF approved by the IEC and any amendment to the ICF later approved by the IEC prior to its use by Institution. Any proposed deviations by Institution from Rigel’s model ICF

Related to Subject Information and Informed Consent

  • Third-Party Agreements and Information Executive represents and warrants that Executive’s employment by the Company does not conflict with any prior employment or consulting agreement or other agreement with any third party, and that Executive will perform Executive’s duties to the Company without violating any such agreement. Executive represents and warrants that Executive does not possess confidential information arising out of prior employment, consulting, or other third party relationships, that would be used in connection with Executive’s employment by the Company, except as expressly authorized by that third party. During Executive’s employment by the Company, Executive will use in the performance of Executive’s duties only information that is generally known and used by persons with training and experience comparable to Executive’s own, common knowledge in the industry, otherwise legally in the public domain, or obtained or developed by the Company or by Executive in the course of Executive’s work for the Company.

  • Documentation and Information Such Stockholder shall not make any public announcement regarding this Agreement or the transactions contemplated hereby without the prior written consent of Parent (such consent not to be unreasonably withheld, conditioned or delayed), except as may be required by applicable Law (provided that reasonable notice of any such disclosure will be provided to Parent, and such Stockholder will consider in good faith the reasonable comments of Parent with respect to such disclosure and otherwise cooperate with Parent in obtaining confidential treatment with respect to such disclosure). Such Stockholder consents to and hereby authorizes Parent to publish and disclose in all documents and schedules filed with the SEC or any other Governmental Entity or applicable securities exchange, and any press release or other disclosure document that Parent reasonably determines to be necessary or advisable in connection with the Offer, the Merger or any other transactions contemplated by the Business Combination Agreement or this Agreement, such Stockholder’s identity, the aggregate number of Subject Shares owned by Stockholders subject to this Agreement, the existence of this Agreement and the nature of such Stockholder’s commitments and obligations under this Agreement, and such Stockholder acknowledges that Parent may, in Parent’s sole discretion, file this Agreement or a form hereof with the SEC or any other Governmental Entity or securities exchange. Such Stockholder agrees to promptly give Parent any information necessary for the preparation of any such disclosure documents, and such Stockholder agrees to promptly notify Parent of any changes with respect to information supplied by such Stockholder specifically for use in any such disclosure document, if and to the extent that any such information shall have become false or misleading in any material respect.

  • Access and Information (a) Upon reasonable notice, each party shall (and shall cause its Subsidiaries to) afford the other party and its representatives (including, without limitation, directors, officers and employees of such party and its affiliates and counsel, accountants and other professionals retained by it) such reasonable access during normal business hours throughout the period prior to the Effective Time to the books, records (including, without limitation, tax returns and work papers of independent auditors), contracts, properties, personnel and to such other information relating to it and its subsidiaries as the other party may reasonably request; provided, however, that no investigation pursuant to this Section 5.3 shall affect or be deemed to modify any representation or warranty made by in this Agreement. (b) From the date hereof until the Effective Time, First Valley Bancorp shall, and shall cause First Valley Bancorp’s Subsidiaries to, promptly provide New England Bancshares with (i) a copy of each report filed with federal or state banking regulators, (ii) a copy of each periodic report to its senior management and all materials relating to its business or operations furnished to its Board of Directors, (iii) a copy of each press release made available to the public and (iv) all other information concerning its business, properties and personnel as New England Bancshares may reasonably request. Notwithstanding the foregoing, neither First Valley Bancorp nor its Subsidiaries shall be required to provide access to or to disclose information where such access or disclosure would violate the rights of such entity’s customers, jeopardize the attorney-client privilege of the entity in possession or control of such information, or contravene any law, rule, regulation, order, judgment, decree or binding agreement entered into prior to the date of this Agreement. The parties hereto will make appropriate substitute disclosure arrangements under circumstances in which the restrictions of the previous sentence apply. (c) New England Bancshares will not, and will cause its representatives not to, use any information obtained pursuant to this Section 5.3 for any purpose unrelated to the consummation of the transactions contemplated by this Agreement. Subject to the requirements of applicable law, New England Bancshares will keep confidential, and will cause its representatives to keep confidential, all information and documents obtained pursuant to this Section 5.3 unless such information (i) was already known to New England Bancshares or an affiliate of New England Bancshares, other than pursuant to a confidentiality agreement or other confidential relationship, (ii) becomes available to New England Bancshares or an affiliate of New England Bancshares from other sources not known by such party to be bound by a confidentiality agreement or other obligation of secrecy, (iii) is disclosed with the prior written approval of First Valley Bancorp or (iv) is or becomes readily ascertainable from published information or trade sources. First Valley Bancorp will not, and will cause its representatives not to, use any information obtained pursuant to this Section 5.3 for any purpose unrelated to the consummation of the transactions contemplated by this Agreement. Subject to the requirements of applicable law, First Valley Bancorp will keep confidential, and will cause its representatives to keep confidential, all information and documents obtained pursuant to this Section 5.3 unless such information (i) was already known to First Valley Bancorp or an affiliate of First Valley Bancorp, other than pursuant to a confidentiality agreement or other confidential relationship, (ii) becomes available to First Valley Bancorp or an affiliate of First Valley Bancorp from other sources not known by such party to be bound by a confidentiality agreement or other obligation of secrecy, (iii) is disclosed with the prior written approval of New England Bancshares or (iv) is or becomes readily ascertainable from published information or trade sources. (d) First Valley Bancorp shall give notice, and shall cause Valley Bank to give notice, to two (2) designees of New England Bancshares, and shall invite such Persons to attend all regular and special meetings of the Board of Directors of First Valley Bancorp and Valley Bank and all regular and special meetings of any senior management committee (including but not limited to the executive committee and the loan and discount committee of Valley Bank) of First Valley Bancorp or Valley Bank. Such designees shall have no right to vote and shall not attend sessions of board and committees during which there is being discussed: (i) matters involving this Agreement; (ii) information or material that First Valley Bancorp or Valley Bank is required or obligated to maintain as confidential under applicable laws or regulations or policies or procedures of First Valley Bancorp or Valley Bank; or (iii) pending or threatened litigation or investigations if, in the opinion of counsel to First Valley Bancorp, the presence of such designees would or might adversely affect the confidential nature of or any privilege relating to the matters being discussed. (e) New England Bancshares shall give notice, and shall cause Enfield Federal to give notice, to two (2) designees of First Valley Bancorp, and shall invite such Persons to attend all regular and special meetings of the Board of Directors of New England Bancshares and Enfield Federal and all regular and special meetings of any senior management committee (including but not limited to the executive committee and the loan and discount committee of Enfield Federal) of New England Bancshares or Enfield Federal. Such designees shall have no right to vote and shall not attend sessions of board and committees during which there is being discussed: (i) matters involving this Agreement; (ii) information or material that New England Bancshares or Enfield Federal is required or obligated to maintain as confidential under applicable laws or regulations or policies or procedures of New England Bancshares of Enfield Federal; or (iii) pending or threatened litigation or investigations if, in the opinion of counsel to New England Bancshares, the presence of such designees would or might adversely affect the confidential nature of or any privilege relating to the matters being discussed.

  • Background Information The Adviser has entered into an Investment Adviser's Agreement with the Fund ("Investment Adviser's Agreement"). Pursuant to the Investment Adviser's Agreement, the Adviser has agreed to render investment advisory and certain other management services to all of the funds of the Fund, and the Fund has agreed to employ the Adviser to render such services and to pay to the Adviser certain fees therefore. The Investment Adviser's Agreement recognizes that the Adviser may enter into agreements with other investment advisers who will serve as fund managers to the funds.

  • Data and Information 14.1 The Contractor shall have the right to use, and shall have access to, all geological, geophysical, drilling, well production, well location maps and other information held by the Republic related to the Contract Area in consideration of the payment of the required fees. 14.2 The Contractor shall promptly provide the Minister, free of cost, with all data obtained as a result of Hydrocarbons Operations under this Contract, including seismic data, geological, geophysical, geochemical, petro-physical, engineering, well logs, maps, magnetic tapes, cores, cuttings and production data, as well as all interpretative and derivative data, including reports, analyses, interpretations and evaluations prepared in respect of Hydrocarbons Operations. 14.3 The Republic shall have title to all original data and information resulting from Hydrocarbons Operations under this Contract, including but not limited to geological, geophysical, petro-physical and engineering data, well logs and completion status reports, and any other data that the Contractor or anyone acting on its behalf may compile or obtain during the term of this Contract. The Contractor is entitled to retain and use a copy of all such data, subject to the provisions of this Article 14. 14.4 The Contractor acknowledges the proprietary rights of the Republic in all data and information referred to in this Article 14 and agrees to treat all such data and information as confidential and to comply with applicable laws and regulations with respect to the storage and any transport or export out of the Republic of any such data and information. 14.5 The Contractor may disclose such information to its employees to the extent required for efficient conduct of Hydrocarbons Operations, provided such individuals have signed or otherwise be subject to an undertaking relating to the confidentiality of the same information as part of their employment contract, or to Affiliates and consultants, or to bona fide prospective assignees of rights under this Contract or to banks or financial institutions from which finance is sought, provided that the Contractor obtains from such entities, prior to disclosure, a written confidentiality undertaking. In the case of disclosure to prospective assignees, any disclosure of such information shall require the prior written consent of the Minister, which consent shall not be unreasonably withheld. 14.6 The Contractor may disclose information as and to the extent required by a regulatory or judicial authority having proper jurisdiction over the Contractor, provided that the Minister is first notified of such disclosure and of the information so disclosed. 14.7 The Contractor’s obligation of confidentiality under this Article shall be of a continuing nature and shall not be cancelled by the expiration, suspension or termination of this Contract, or by any transfer or assignment of interest under this Contract.

  • Reports and Information Contractor shall at such times and in such forms as the City may require furnish the City such periodic reports as it may request pertaining to the work or services undertaken pursuant to this Agreement, the costs and obligations incurred or to be incurred in connection therewith, and any other matters are covered by this Agreement as specified in Exhibit A and Exhibit E.

  • Access to Certain Documentation and Information Regarding the Loans The Servicer shall provide access to the Trustee or to its designees at its request, and to Certificateholders which are savings and loan associations, banks or insurance companies, the OTS, the FDIC and the supervisory agents and examiners of the OTS and the FDIC or examiners of any other federal or state banking or insurance regulatory authority to the documentation regarding the Loans if so required by applicable regulations of the OTS or other regulatory authority, such access to be afforded without charge but only upon reasonable request and during normal business hours at the offices of the Servicer designated by it. The Trustee or its designee may without charge copy any document or electronic record maintained by the Servicer hereunder.

  • Access to Certain Documentation and Information Regarding Receivables The Servicer shall provide to representatives of the Trustee, the Owner Trustee and the Trust Collateral Agent reasonable access to the documentation regarding the Receivables. In each case, such access shall be afforded without charge but only upon reasonable request and during normal business hours. Nothing in this Section shall affect the obligation of the Servicer to observe any applicable law prohibiting disclosure of information regarding the Obligors, and the failure of the Servicer to provide access as provided in this Section as a result of such obligation shall not constitute a breach of this Section.

  • Access to Certain Documentation and Information The Trustee shall provide the related Certificateholders or Certificate Owners with access to a copy of each report, if any, received by it as holder of the Deposited Underlying Certificates under the Underlying Agreement. The Trustee shall also provide the Depositor and the Underlying Certificate Seller with access to any such report and to all written reports, documents and records required to be maintained by the Trustee in respect of its duties hereunder. Such access shall be afforded without charge but only upon reasonable request evidenced by prior written notice received by the Trustee two Business Days prior to the date of such proposed access and during normal business hours at offices designated by the Trustee.

  • Access to Certain Documentation and Information Regarding the Mortgage Loans The Master Servicer shall afford the Depositor and the Trustee reasonable access to all records and documentation regarding the Mortgage Loans and all accounts, insurance information and other matters relating to this Agreement, such access being afforded without charge, but only upon reasonable request and during normal business hours at the office designated by the Master Servicer. Upon reasonable advance notice in writing, the Master Servicer will provide to each Certificateholder or Certificate Owner which is a savings and loan association, bank or insurance company certain reports and reasonable access to information and documentation regarding the Mortgage Loans sufficient to permit such Certificateholder or Certificate Owner to comply with applicable regulations of the OTS or other regulatory authorities with respect to investment in the Certificates; provided that the Master Servicer shall be entitled to be reimbursed by each such Certificateholder or Certificate Owner for actual expenses incurred by the Master Servicer in providing such reports and access.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!