Patient Information and Consent Sample Clauses

Patient Information and Consent. An ICF that includes information about the study will be prepared and given to the patient, or the patient’s legally authorized representative(s). The ICF will contain all FDA and ICH required elements and be approved by an IRB/IEC. The ICF must be in a language understandable to the patient or the patient’s legally authorized representative(s). Before enrolling in the clinical study, the nature, scope, and possible consequences of the clinical study will be explained to the patient or the patient’s legally authorized representative(s) in a form understandable to him or her. After the patient has been given ample time to read and ask questions regarding the ICF and has been informed that participation is voluntary, the patient or the patient’s legally authorized representative(s) must give consent in writing. If the patient or the patient’s legally authorized representative(s) is unable to read, oral presentation and explanation of the written ICF and information to be supplied must take place in the presence of an impartial witness. Consent must be confirmed orally and by the personally dated signature of the patient or by the patient’s legally authorized representative(s). The witness and the person conducting the informed consent discussions must also sign and personally date the informed consent document. The informed consent process must be recorded and dated in the patient’s source document. A copy of the signed and dated consent document(s) must be given to the patient or the patient’s legally authorized representative(s). The original signed and dated consent document will be retained by the Investigator. Patient confidentiality will be maintained as outlined in Section 12.3. The Investigator must not undertake any measures specifically required solely for the clinical study until valid informed consent has been obtained. A model of the pre-screening and the main study ICF will be provided to the sites separately for this protocol. The main study consent can be used to confirm a patient’s consent to all study procedures and all study-specific screening tests. The pre-screening ICF can be used to pre- screen patients for FRα status before performing any additional study related tests. If a patient is eligible based on FRα expression level, the patient will be provided the main study consent and only after signing the main study ICF will additional study-specific screening tests be performed. Alternatively, the patient can be consented on both pre-sc...