The Clinical Trials Program (CTP) faculty/staff will offer real-world training on implementation of study protocols, use of the Investigator Brochure, fulfillment of Institution Review Board (IRB) requirements, utilization of standard operating procedures, maintenance of study documentation, attainment of informed consent, recruitment and retention of subjects, and performance of quality assurance. Interns will observe investigators, study coordinators, and other research personnel interact with research subjects, Contract Research Organization (CRO) employees and sponsors. Completion of readings and on-line training regarding human research ethics and Good Clinical Practice are required.
Interns will gain insight into the conduct of studies performed under FDA Good Clinical Practice (GCP) guidelines.
Grading (satisfactory/unsatisfactory) is based on participation, attendance, effective completion of assigned tasks, and submission of a final course evaluation by the student.