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.
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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.
Sample 1
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
Sample 1
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
Sample 1
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.
Sample 1

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 The Company, on the one hand, and Parent and Acquisition Corp., on the other hand, shall each afford to the other and to the other’s accountants, counsel and other representatives full access during normal business hours throughout the period prior to the Effective Time to all of its properties, books, contracts, commitments and records (including but not limited to tax returns) and during such period, each shall furnish promptly to the other all information concerning its business, properties and personnel as such other party may reasonably request, provided that no investigation pursuant to this Section 6.01 shall affect any representations or warranties made herein. Each party shall hold, and shall cause its employees and agents to hold, in confidence all such information (other than such information that (a) is already in such party’s possession or (b) becomes generally available to the public other than as a result of a disclosure by such party or its directors, officers, managers, employees, agents or advisors or (c) becomes available to such party on a non-confidential basis from a source other than a party hereto or its advisors, provided that such source is not known by such party to be bound by a confidentiality agreement with or other obligation of secrecy to a party hereto or another party until such time as such information is otherwise publicly available; provided, however, that (i) any such information may be disclosed to such party’s directors, officers, employees and representatives of such party’s advisors who need to know such information for the purpose of evaluating the transactions contemplated hereby (it being understood that such directors, officers, employees and representatives shall be informed by such party of the confidential nature of such information), (ii) any disclosure of such information may be made as to which the party hereto furnishing such information has consented in writing and (iii) any such information may be disclosed pursuant to a judicial, administrative or governmental order or request; provided, further, that the requested party will promptly so notify the other party so that the other party may seek a protective order or appropriate remedy and/or waive compliance with this Agreement and if such protective order or other remedy is not obtained or the other party waives compliance with this provision, the requested party will furnish only that portion of such information that is legally required and will exercise its best efforts to obtain a protective order or other reliable assurance that confidential treatment will be accorded the information furnished. If this Agreement is terminated, each party will deliver to the other all documents and other materials (including copies) obtained by such party or on its behalf from the other party as a result of this Agreement or in connection herewith, whether so obtained before or after the execution hereof.

  • 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 In furtherance of the authority contained in this Article 5, one or more of the Parties are authorized to obtain, compile, maintain, share, and exchange among themselves, or with one or more third parties, information related to any aspect of intermodal transport, equipment use, inland or marine terminals, operations, cargo throughput, transportation or traffic volumes, equipment use, and/or other information pertaining to matters authorized under this Article 5. Such information may include records, statistics, studies, compilations, projections, costs, data, and electronic or paper documents of any kind or nature whether prepared by a Party or the Parties or obtained from outside sources, relating to matters authorized by Article 5.

  • 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.

  • CONFIDENTIALITY of RECORDS and INFORMATION 20.1. XXXXXXXXXX agrees to maintain confidentiality of information and records as required by applicable Federal, State and local laws, regulations and rules. CONTRACTOR shall not use or disclose confidential information other than as permitted or required by this Agreement and will notify COUNTY of any discovered instances of breaches of confidentiality. CONTRACTOR shall ensure that any subcontractors’ agents receiving confidential information related to this Agreement agree to the same restrictions and conditions that apply to CONTRACTOR with respect to such information. XXXXXXXXXX agrees to hold COUNTY harmless from any breach of confidentiality, as set forth in the hold harmless provisions contained herein. 20.1.1. HIPAA/ Protected Health Information. If CONTRACTOR is a covered entity under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) or the HIPAA Business Associate Agreement (BAA) Addendum is included as part of this Agreement, it is obliged to comply with applicable requirements of law and subsequent amendments relating to any protected health information, as well as any task or activity CONTRACTOR performs on behalf of COUNTY, to the extent COUNTY would be required to comply with such requirements. If this Agreement has been determined to constitute a business associate relationship under HIPAA and the HIPAA regulations, CONTRACTOR is the Business Associate of COUNTY and agrees to the HIPAA Business Associate Agreement (BAA) Addendum exhibit attached to this Agreement. 20.1.2. 42 C.F.R. Part 2/ Drug and Alcohol Abuse Records. If CONTRACTOR is a covered program under the Confidentiality of Alcohol and Drug Abuse Patient Records Act, 42 C.F.R. Part 2 or signs the Qualified Service Organization Agreement (QSOA), it is obliged to comply with applicable requirements of law and subsequent amendments relating to any protected health information and patient identifying information, as well as any task or activity CONTRACTOR performs on behalf of COUNTY, to the extent COUNTY would be required to comply with such requirements. If this Agreement has been determined to constitute a qualified service organization relationship under 42 C.F.R. Part 2 and the 42 C.F.R. Part 2 regulations, CONTRACTOR is the Qualified Service Organization of COUNTY and agrees to enter into the Qualified Service Organization Agreement (QSOA) Addendum contained as an exhibit to this Agreement.

  • 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.

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