Implementation of the Clinical and Translational Research Protocol

Catalog description

This course will focus on topics related to successful protocol implementation such as investigational product administration, bio specimen sampling and pharmacokinetics, post administration period monitoring including assessments, clinical monitoring and observation, long-term follow up, and principal investigator oversight. To do this, students will develop a fundamental understanding of product development including phase 1 and first in human studies. Students will be exposed to techniques for creating professional partnerships with clinical research stakeholders including Investigational Drug Service, Radiology, Industry Sponsors, Hospital Administrators, Ancillary Staff, Laboratory Professionals, Principal Investigators, and Basic Scientists. Students will also explore the role of the clinical research nurse in the context of recruitment and retention of participants through managing the patient/family relationship.