Subject Information and Consent. Voluntary written informed consent will be obtained from one parent/caregiver of each subject prior to performing any study-related procedures. Each parent/caregiver will be given both verbal and written information describing the nature and duration of the clinical study. The informed consent process will take place under conditions where the parent/caregiver has adequate time to consider the risks and benefits associated with the child’s participation in the study. Subjects will not be screened or treated until the parent/caregiver has signed an approved informed consent written in a language that is understandable to the subject. The participation of the study should be discussed with the subject <14 years of age according to the child’s age and ability and verbal assent should be obtained. The informed consent will be given by the signature of one parent. Voluntary written informed assent will be obtained from adolescents ≥ 14 years in addition to parent’s written informed consent. Each subject will be given both verbal and written information describing the nature and duration of the clinical study. The informed assent process will take place under conditions where the subject has adequate time to consider the risks and benefits associated with the participation in the study. Subjects will not be screened or treated until the subject has signed an approved informed assent written in a language that is understandable to the subject. The IEC/IRB approved informed consent/assent form will be signed and personally dated by the parent/caregiver (or legally acceptable representative, when appropriate) and the person who conducted the informed consent discussion. Each parent/caregiver is to receive a copy of the signed and dated written informed consent form and any other written subject information. The signature of an impartial witness is to be obtained in the event the subject or the subject’s legally acceptable representative is unable to read. Additional signatures on the informed consent form may be required in accordance with IEC/IRB requirements or those of the Sponsor (or an authorized representative). The Investigator is responsible for assuring the appropriate content of the informed consent form and that informed consent is obtained from each parent/caregiver in accordance with the applicable regulations and guidelines. The original signed informed consent is to be retained in the study documentation files. The Investigator shall maintain a log o...
Subject Information and Consent. The informed consent form and any changes to the informed consent form made during the course of the trial must be agreed to by VIVUS, Inc. or designee and the IRB/IEC prior to its use and must be in compliance with all ICH-GCP, local regulatory requirements and legal requirements. The investigator must ensure that each trial subject is fully informed about the nature and objectives of the trial and possible risks associated with participation and must ensure that the subject has been informed of his/her rights to privacy. The investigator will obtain written informed consent from each subject before any trial-specific activity is performed and should document in the source documentation that consent was obtained prior to enrollment in the trial. The original signed copy of the informed consent form must be maintained by the investigator and is subject to inspection by a representative of VIVUS, Inc., their representatives, auditors, the IRB/IEC and/or regulatory agencies. A copy of the signed informed consent form will be given to the subject.
Subject Information and Consent. Assent The informed consent form and any changes to the informed consent form during the course of the trial must be agreed to by VIVUS and the IRB/IEC and must be in compliance with ICH GCP, local regulatory requirements, and legal requirements. The investigator or designee(s) must ensure that each clinical study subject is fully informed about the nature and objectives of the clinical trial and possible risks associated with participation. The investigator or designee(s) will obtain written informed consent from each subject before any trial-specific activity is performed. The informed consent form used in this clinical trial, and any changes made during the course of the trial, must be prospectively approved by both the IRB/IEC and VIVUS before use. The original signed copy of the informed consent form must be maintained by the investigator and is subject to inspection by a representative of VIVUS, their representatives, auditors, the IRB/IEC and/or regulatory agencies. A copy of the signed informed consent form will be given to the subject. Parental consent and/or subject assent will be obtained according to IRB/IEC guidelines.
Subject Information and Consent. Prior to any testing under this protocol, including screening tests and elevations, written informed consent will be obtained from the subject in accordance with local practice and regulations. Whenever possible, the investigator will also be involved in this procedure. The background of the proposed study and the benefits and risks of the procedures and study will be explained to the subject. A copy of the informed consent document signed and dated by the subject must be given to the subject. Confirmation of a subject's informed consent must also be documented in the subject's medical records prior to any testing under this protocol, including screening tests and evaluations.
