Informed Consent Process. It is the responsibility of the investigator to inform each patient, prior to the screening evaluation, of the purpose of this clinical trial, including possible risks and benefits and document the informed consent process in the patient’s chart. A sample informed consent form containing the required elements of informed consent is provided in Appendix 2. Any changes made to this sample must be approved by ViroMed or its designee, prior to submission to an IRB. After approval by ViroMed or its designee, the informed consent must be submitted to and approved by an IRB. Prior to entry into the study or initiation of any study-related procedures, the patient must read, sign and date the informed consent form. The person executing the consent must also sign and date the final consent form page. Patients will be asked to initial each page of the informed consent form to acknowledge awareness of its contents. One original informed consent form is to be retained by the study site and a copy is to be given to the patient. The informed consent process must be documented in the patient’s medical record. The informed consent must be written in a language in which the patient is fluent. If a foreign language translation is required, a statement of certification of the translation must be issued. Regulations require that foreign language informed consent forms be submitted to the IRB for approval. The investigator must forward a copy of the consent form, the certified foreign language translation and an IRB approval letter to ViroMed Co., Ltd.
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