The ORNCS faculty/staff will offer practical training on development/use of study protocols, standard operating procedures, study-specific and facility documentation, equipment and qualification, data/sample retention and Quality Control/Quality Assurance (QC/AQ.) Trainees participating in this internship will shadow study directors, scientific/technical personnel, records management and archiving personnel, and quality assurance unity (QAU) personnel. Interns will gain an advanced understating of the FDA Good Laboratory Practice (GLP) and Animal Rule regulations, Implementation and operation of quality management system, and the design execution, reporting and quality oversight of animal efficacy studies supporting licensure of vaccines and other medical countermeasures. Trainees participating in internship may also be able to attend UTMB-FDA sponsored training activity, “Achieving Data Quality and Integrity in Maximum Containment Laboratories”, which is held annually at the National Institutes of Health in Bethesda, MD, focusing on animal mode regulatory expectations under the FDA’s Animal Rule. Grading (satisfactory/unsatisfactory) is based on participation, attendance and effective completion of assigned tasks.