Subject Information and Informed Consent. Each subject (or a legally authorized representative) must give written informed consent prior to any 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.
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.
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 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. 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
