Specifications include, but are not limited to: Managing the regulatory life cycle of new and amended protocols for both single-site and multi-site research protocols. Review and approve or disapprove new and amended protocols. Serve as the single IRB for multi-site research protocols. Review and approve, request modification, or disapprove consent forms . Review and assess qualifications of investigator(s) . Monitor adverse event reports; and maintain required IRB records pursuant to 21 CFR § 56.115 and/or 45 CRF § 46.115 . The Contractor shall conduct continuing review of research studies appropriate to the degree of risk in such studies. . The Contractor must conduct at least an annual review of each previously approved study, pursuant to federal requirements and Virginia Tech policies.