Polaris

SOP# SITE-009.0CompanyEffective Date: DD/MMM/YYf. The assent form was signed and dated by the minor and the person whoobtained the consent.g. Each page of the consent is initialed by the parent and each page of the assentis initialed by the minor.h. The parent and minor are given a copies of the signed consent and assent.8. The Study Coordinator will ensure that the original, signed copies of the consentand assent are stored in the study file.D. Revised Consent Forms1. When the Investigator and/or Study Coordinator receive updates to theInvestigator’s Brochure, IND Safety Reports, or protocol amendments, he/sheshould also review the informed consent to determine if it should be revised toreflect the new information.2. No changes to the study procedures that are a result of the protocol amendmentwill be implemented until the IRB approval of the amendment is received.3. If the consent form is changed as a result of a protocol amendment, the StudyCoordinator will ensure that the revised consent is approved by the IRB.4. The Investigator, Study Coordinator, or Investigator’s delegate will explain thechanges to the subject and will provide the subject with the revised consent formfor review and signature.5. If the subject decides to continue in the study and signs the consent form, theStudy Coordinator or Investigator’s delegate will provide the subject with a copyof the revised consent and will place the original in the study file.E. Non-English Speaking Subjects1. If the patient population contains numerous non-English speaking people whomay qualify for the study, the Study Coordinator will ensure that the informedconsent is translated into the second language and that the translated consent formis also approved by the IRB.2. The Study Coordinator will file the certificate of translation in the RegulatoryDocuments Binder with the translated consent.3. If possible, someone at the study site who speaks the same language as thepotential subject will explain the study to the subject. This person will also beavailable at subsequent study visits to ensure that the subject’s questions can beanswered as the study progresses.SITE-009.0.doc© 2004 by CRC Press LLC