Master of Science in Clinical Research for Health Professionals (CRHP)

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Curriculum

This program requires the successful completion of 36 credits: three required courses, two electives and 21 research credits. The required mentored research project provides the opportunity for students to apply the knowledge gained in the didactic portion of the program and to gain experience in interpreting and presenting the findings of clinical research. Research may include a broad spectrum of clinical studies such as:

·         retrospective studies;

·         bench-top studies in conjunction or not with pharmaceutical companies;

·         development of new clinical methodologies/techniques; or

·         development/evaluation of new clinical devices.

 

The research requirement will be fulfilled by students devoting a minimum of 9 hours per week for 3 credits per semester. The student must submit a 7-10 page journal-format paper at the end of each semester documenting their research and demonstrating that each successive semester’s work builds upon their prior work.
 

Clinical Research for Health Professionals (CRHP) Research Project Proposal.

Complete the CRHP research request form with contact information for your research advisor.  You may fax or email your research mentor’s CV along with the CRHP Research Request Form and a supplemental document describing:
 
   1) your project title
   2) the objectives of your project 
   3) your hypothesis
   4) and outline of your planned activities

 


Required Courses
Select three of the following courses:
CR 500SEPIDEMIOLOGY3.00 credits
CR 515SINTRO TO CLINICAL TRIALS3.00 credits
CR 520SApplications of Clinical Research Biostatistics3.00 credits
CR 525SSCIENTIFIC WRITING & MED LIT3.00 credits
CR 545SPHARMACEUTICAL LAW3.00 credits
CR 612SFUNDAMENTALS OF COMPLIANCE3.00 credits

Elective Courses
Select two of the following courses:
CR 505SETHICAL ISSUES IN RESEARCH3.00 credits
CR 511SThe History of Misconduct in Biomedical Research 3.00 credits
CR 535SCurrent Federal Regulatory Issues in Biomedical Research 3.00 credits
CR 565SContemporary Issues in Human Research Protection3.00 credits
CR 570SPrinciples and Practice of Pharmacovigilance3.00 credits
CR 600SDESIGNING THE CLINICAL TRIAL3.00 credits
CR 609SINNOVATIVE PRODUCE DEVELOPMENT3.00 credits
CR 616SIntro to Therapeutic Products3.00 credits
CR 617SInformatics in Pharm Res & Development3.00 credits
CR 620SBIOTECH/RESEARCH3.00 credits
CR 625SHEALTH POLICY AND ECONOMICS3.00 credits
Note:
Students may also choose from CR 505S, CR 515S, CR 520S, CR 525S, CR 612S or CR 545S

Research Courses
Each student conducts a minimum of 9 hours of research/week for 3 credits per semester
CRHP 501SResearch Health Professions I3.00 credits
CRHP 502SResearch Health Professions II3.00 credits
CRHP 503SResearch Health Professions III3.00 credits
CRHP 504SResearch Health Professions IV3.00 credits
CRHP 505SResearch Health Professions V3.00 credits
CRHP 506SResearch Health Professions VI3.00 credits
CRHP 507SResearch Health Professions VII3.00 credits

Course Descriptions

CR 500S EPIDEMIOLOGY - 3.00 credits

Epidemiology is at the core of research professions as it is the study of the distribution, determinants, and the course of health related events in populations, and the efficacy and effectiveness of prevention and intervention strategies.

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CR 515S INTRO TO CLINICAL TRIALS - 3.00 credits

This course introduces regulatory responsibilities of clinical investigators, sponsors, monitors, IRBs, FDA -all those parties intimately involved in clinical research. Information and exercises are designed to reinforce the elements of Good Clinical Practices.

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CR 520S Applications of Clinical Research Biostatistics - 3.00 credits

Examines role of the statistician in clinical research. Course includes a discussion of the language of statistics to facilitate communication with the clinical research project team, basic methods of describing data, fundamentals of probability, simple models and methods of parameter estimation and statistical software packages for reporting data.

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CR 525S SCIENTIFIC WRITING & MED LIT - 3.00 credits

This course teaches the medical professional the ability to read for understanding, and evaluate validity of information a medical or scientific paper. In addition, the student learns how to recognize various types of medical literature and the basics of how to perform a review of the medical literature.

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CR 545S PHARMACEUTICAL LAW - 3.00 credits

Presents principles and practices of the Federal Food, Drug and Cosmetic Act governing the research and development of pharmaceuticals and biologics for both humans and animals including an analysis of legal and social constructs affecting industry and the academic clinical investigator with emphasis on FDA enforcement actions.

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CR 612S FUNDAMENTALS OF COMPLIANCE - 3.00 credits

The study of the federal bodies and regulations that govern research. Topics include: the rules and regulations surrounding HIPAA and how it affects research on human subjects, the history and current role of the FDA, IACUC, and the IRB within the research arena. May be repeated twice for credit.

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CR 505S ETHICAL ISSUES IN RESEARCH - 3.00 credits

Students explore ethical issues to sound clinical research, review the foundations of regulations for clinical investigations, and to better understand the operational imperatives of Good Clinical Practices.

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CR 511S The History of Misconduct in Biomedical Research - 3.00 credits


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CR 535S Current Federal Regulatory Issues in Biomedical Research - 3.00 credits


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CR 565S Contemporary Issues in Human Research Protection - 3.00 credits


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CR 570S Principles and Practice of Pharmacovigilance - 3.00 credits

This course is an introduction to the ethical, clinical, and regulatory complexities of medication safety and matters thinking skills for improving the quality and effectiveness of drug safety monitoring for both the pharmaceutical industry and its impact on the public.

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CR 600S DESIGNING THE CLINICAL TRIAL - 3.00 credits

Designers and ethical, clinical, strategic issues surrounding clinical drug research are the focus of this course. Topics include design of trials for Phases one though four, an overview of the statistical component of a clinical trial, monitoring of the trial, and managing clinical data.

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CR 609S INNOVATIVE PRODUCE DEVELOPMENT - 3.00 credits

This comprehensive course provides a solid foundation in new therapeutic product research and development for the subsequent courses in the CROM program. This course focuses on the process of drug and medical device development from early research, discovery, and product formulation, through the federal requirements form proving safety and efficacy. May be repeated twice for credit.

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CR 616S Intro to Therapeutic Products - 3.00 credits

This course is designed to provide an overview of the diverse marketing and advertising practices and strategies of the pharmaceutical industry and their impact on the professional healthcare infrastructure, as well as on the healthcare recipient population. Students will be encouraged to develop skills to crucially evaluate the marketing techniques of the pharmaceutical industry.

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CR 617S Informatics in Pharm Res & Development - 3.00 credits

Using a combination of printed materials, case studies, literature reviews, and on-line discussions, this course will cover past and present contributions of computer applications in pharmaceutical research and development. In addition, the student will be challenged to portend where technological advances may prove to be strategically beneficial in the future.

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CR 620S BIOTECH/RESEARCH - 3.00 credits

The study of the history, use and progression of biological techniques developed through basic research and now how it is applied to research and product development.

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CR 625S HEALTH POLICY AND ECONOMICS - 3.00 credits

The study of the development, analysis and communication of economic data in the context of clinical research. May be repeated twice for credit.

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CRHP 501S Research Health Professions I - 3.00 credits

CRHP requires research plus a 7-10 page journal-type paper on a topic approved by the Program Director. Research may include a broad spectrum of clinical studies such as: retrospective studies; bench-top studies in conjunction or not with pharmaceutical companies; development of new clinical methodologies/techniques; or development/evaluation of new clinical devices.

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CRHP 502S Research Health Professions II - 3.00 credits

CRHP requires research plus a 7-10 page journal-type paper on a topic approved by the Program Director. Research may include a broad spectrum of clinical studies such as: retrospective studies; bench-top studies in conjunction or not with pharmaceutical companies; development of new clinical methodologies/techniques; or development/evaluation of new clinical devices.

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CRHP 503S Research Health Professions III - 3.00 credits

CRHP requires research plus a 7-10 page journal-type paper on a topic approved by the Program Director. Research may include a broad spectrum of clinical studies such as: retrospective studies; bench-top studies in conjunction or not with pharmaceutical companies; development of new clinical methodologies/techniques; or development/evaluation of new clinical devices.

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CRHP 504S Research Health Professions IV - 3.00 credits

CRHP requires research plus a 7-10 page journal-type paper on a topic approved by the Program Director. Research may include a broad spectrum of clinical studies such as: retrospective studies; bench-top studies in conjunction or not with pharmaceutical companies; development of new clinical methodologies/techniques; or development/evaluation of new clinical devices.

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CRHP 505S Research Health Professions V - 3.00 credits

CRHP requires research plus a 7-10 page journal-type paper on a topic approved by the Program Director. Research may include a broad spectrum of clinical studies such as: retrospective studies; bench-top studies in conjunction or not with pharmaceutical companies; development of new clinical methodologies/techniques; or development/evaluation of new clinical devices.

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CRHP 506S Research Health Professions VI - 3.00 credits

CRHP requires research plus a 7-10 page journal-type paper on a topic approved by the Program Director. Research may include a broad spectrum of clinical studies such as: retrospective studies; bench-top studies in conjunction or not with pharmaceutical companies; development of new clinical methodologies/techniques; or development/evaluation of new clinical devices.

Back to course list

CRHP 507S Research Health Professions VII - 3.00 credits

CRHP requires research plus a 7-10 page journal-type paper on a topic approved by the Program Director. Research may include a broad spectrum of clinical studies such as: retrospective studies; bench-top studies in conjunction or not with pharmaceutical companies; development of new clinical methodologies/techniques; or development/evaluation of new clinical devices.

Back to course list