Written Informed Consent Sample Clauses

Written Informed Consent. The investigator(s) at each center will ensure that the subject is given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study. Subjects must also be notified that they are free to discontinue from the study at any time. The subject should be given the opportunity to ask questions and allowed time to consider the information provided. The subject’s signed and dated informed consent must be obtained before conducting any study procedures. The investigator(s) must maintain the original, signed ICF. A copy of the signed ICF must be given to the subject.
Sample 1
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Written Informed Consent. Because the study will be conducted under a United States Investigational New Drug Application, a signed informed consent form, in compliance with Title 21 of the United States Code of Federal Regulations (CFR Part 50, will be obtained from each patient before the patient enters the study. For sites outside of the United States, the signed consent will be obtained in accord with local regulations, ICH E6 (R1, and principles of the Declaration of Helsinki. An informed consent template may be provided by the Sponsor or designee to the investigators. The consent must be reviewed by the Sponsor or designee before IRB/EC submission. Once reviewed, the consent will be submitted by the principal investigator to his or her IRB/EC for review and approval before the start of the study. If the informed consent form is revised during the course of the study, all participants affected by the revision must sign the revised IRB/EC- approved consent form. Before enrollment, each prospective patient will be given a full explanation of the study and be allowed to read the approved informed consent form. Once the principal investigator or designee is assured that the patient understands the implications of participating in the study, the patient will be asked to give consent to participate in the study by signing the informed consent form.‌ Eligible patients may only be included in the study after providing written (witnessed, where required by law or regulation), IRB/EC-approved informed consent. Informed consent must be obtained before conducting any study-specific procedures (i.e., all of the procedures described in the protocol). The process of obtaining informed consent must be documented in the patient source documents. Any changes to the proposed consent form suggested by the investigator must be agreed to by the Sponsor before submission to the IRB/EC, and a copy of the approved version and the notice of approval must be provided to the Sponsor’s designated monitor after IRB/EC approval. The principal investigator or designee will provide a copy of the informed consent form (signed copy to be provided per applicable law) to the patient and/or legal guardian. The original form will be maintained in the patient’s medical records at the site.
Sample 1
Written Informed Consent. Prior to enrolling a trial participant, the investigator(s) will ensure that the participant is given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study. Participants must also be notified that they are free to discontinue from the study at any time. The participant should be given the opportunity to ask questions and allowed time to consider the information provided. When the participant decides to participate in the trial, the participant (or the participant’s, parent or legally authorized representative) must provide signed and dated informed consent. The written consent must be obtained before conducting any study procedures. The investigator must document the consent process in the participant’s source records. The investigator must maintain the original, signed Informed Consent Form. A copy of the signed Informed Consent Form must be given to the participant or to the participant’s parent or legally authorized representative. Throughout the trial participants should be informed of any changes made to the study and as new safety and or risk information becomes known. The provision of this information will be documented in the participant’s source records, and when applicable, an updated ICF will be provided.
Sample 1
Written Informed Consent. The Principal Investigator will ensure that the subject is given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. Subjects must also be notified that they are free to discontinue from the study at any time. The subject should be given the opportunity to ask questions and allowed time to consider the information provided before signing the ICF. As additional assessments, the ICF will contain provisions for optional consent for the collection of blood samples for hormone and biomarker testing during screening and the collection of breast milk for biobanking purposes. The ICF, as specified by the clinical site’s IRB, must follow the Protection of Human Subjects regulations listed in the Code of Federal Regulations, Title 21, Part 50. The subject’s signed and dated informed consent must be obtained before conducting any study procedures. The Principal Investigator(s) must maintain the original, signed ICF. A copy of the signed ICF must be given to the subject.
Sample 1
Written Informed Consent. The Investigator(s) at each center will ensure that the patient (as age appropriate) and the patient’s parent(s) or legal guardian(s) are given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. Patients and their parent(s) or legal guardian(s) must also be notified that they are free to discontinue from the study at any time. The patients and their parent(s) or legal guardian(s) should be given the opportunity to ask questions and allowed time to consider the information provided. The patient’s signed and dated informed consent form must be obtained before conducting any study procedures. Assent from patients will also be obtained at Screening or at any time during the study, if possible, in an age-appropriate manner, per federal regulations (Code of Federal Regulations, Title 45, Part 46.408) and local requirements. The Investigator(s) must maintain the original, signed informed consent form. A copy of the signed informed consent form must be given to the patient and the patient’s parent(s) or legal guardian(s).
Sample 1
Written Informed Consent. The Principal Investigator at each center will ensure that the subject is given full and adequate oral and written information about the nature, purpose, possible risk and possible benefit of the study. Subjects must also be notified that they are free to withdraw from the study at any time. Subjects should be given the opportunity to ask questions and allowed time to consider the information provided. Before participating in any study-related activity, voluntary informed consent must be documented by the use of a written ICF approved by the IRE or IEC and signed and dated by the subject or the subject's legally authorized representative at the time of consent. The original signed and dated ICF will be retained with the study records, and a copy of the signed ICF will be given to the subject or the subject's legally authorized representative.
Sample 1
Written Informed Consent. ‌ The schedule of study activities (including assessments, tests, exams, disease assessments, and study drug administration) beginning with screening and continuing through the end of study are outlined in Table 3. A written, signed informed consent form (ICF) must be obtained from each subject prior to performing any study related procedure (e.g., xxxxx xxxxx, clinical laboratory sampling, or photography). The Principal Investigator at each center will ensure that the subject is given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study. Subjects must also be notified that they are free to discontinue from the study at any time. The subject should be given the opportunity to ask questions and allowed time to consider the information provided. The subject’s signed and dated informed consent must be obtained before conducting any study procedures. The Principal Investigator must maintain the original, signed Informed Consent Form. A copy of the signed Informed Consent Form must be given to the subject.
Sample 1
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Related to Written Informed Consent

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