As requested: Prepare, submit, and maintain timely and accurate initial, continuing and final regulatory documents to the IRB, sponsors and state or federal regulatory offices as necessary, including but not limited to: Amendments, Addendums, Investigator's Brochures, Safety Information, Form FDA 1572s and informed consent documents. Complete study documentation and maintains study files in accordance with sponsor requirements and MNGI policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.