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Clinical Research Associate Graduate Certificate

Clinical Research Associate Graduate Certificate

Starting Spring 2018

The Graduate Certificate in Clinical Research requires 15 credit hours of course work. This certificate program is not covered by federal or state financial aid. Students may apply for available scholarships.

For additional requirements, please see the Master of Health Science Admissions Page

 

15 semester hours required (All courses required).

course name semester hours
MHS 5904: Research Ethics
This course introduces students to ethics concepts as they apply to questions and challenges in conducting research with human subjects. The aim is to increase students' awareness of and ability to reason through ethical issues that arise in human subjects. The course will draw upon historical examples and codes, declarations, and other sources of ethical guidance including contemporary controversies in research with human subjects.
3
MHS 6002: Clinical Trial Process

This course provides students with the crucial aspects of the overall Clinical Trial process. Students will become familiar with the rationale for Clinical Trials, key terminology and processes associated with Clinical Trials, the design of Clinical Trials, and key plans and documents used in the conduct of Clinical Trials. The course will draw upon historical examples and codes, declarations, and other sources of regulation and Trial conduct guidance along with practical examples of Trial design and management documentation.

3
MHS 6003: Legal, Safety, Regulatory Compliance and Best Practices

This course provides students the foundational knowledge of legal and regulatory compliance and best practices for the conduct of a Clinical Trial. It will also introduce the role of Quality Assurance, Quality Management Systems and Standard Operating Procedures (SOPs). The aim is to familiarize students with various jurisdictional regulations, guidance required of a practitioner in the area the Clinical Trials and the checks and balances in place to ensure compliance. The course will include lecture, case studies, and use of online reading assignment.

3
MHS 6604: Reporting Clinical Trial Results in Different Media & Externship
This course provides students the foundational knowledge and practice cases on medical writing regulatory submissions, general management and communication skills required during the conduct of Clinical Trials. The course will include lecture, case studies, and student participation in presentations, role play assignments, and written reports.
3
MHS 6605: Clinical Trial Conduct
The course takes students through the conduct of a Clinical Trial. The ultimate goal of the course is to have students become knowledgeable with the functions performed by a clinical research associate (CRA) during a clinical trial. Students will comprehend the various segments of clinical trials and the multiple duties and responsibilities involved in each. The course will incorporate online delivery of lectures, selected case studies, and the utilization of online technological learning aides.
3
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