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Master of Science in Clinical Research Organization and Management

Curriculum

The Master of Science in Clinical Research Organization and Management consists of 36 credits (12 courses). The program combines five areas of study devoted to clinical research and related administrative and regulatory issues:

  • Innovative Product Research and Development
    • Courses were designed to hone skills in the essentials for developing new therapeutic products encompassing the basic and clinical sciences and for understanding the trends in clinical research.
  • Regulatory Compliance and Law
    • Compliance to ethical, legal, and regulatory standards is essential for ensuring quality research. Using these professional requirements, courses were designed to build a solid core of knowledge in the areas necessary to guarantee the integrity of research involving a human population.
  • Biostatistics and Data Management
    • Courses in this track focus on design and data management for the clinical trial to ensure that it is properly designed so as not to put human research participants at risk.
  • Clinical Research Management and Safety Surveillance
    • This module encompasses a variety of courses necessary to better understand project management, the vagaries of the innovative product development industry, and strategies for coping and surviving in this ever shifting environment.
  • Business and Strategic Planning of New Product Development
    • Courses in this track focus on the business and strategies needed to conduct a clinical trial.
Students take courses within their preferred area of study as well as a cross section of courses within the other areas of study.

Textbooks

Textbooks for this program can be ordered through any online bookstore such as Amazon.com.

Courses
CR 500SEPIDEMIOLOGY3.00 credits
CR 501SEmerging Trends in Medical Device History3.00 credits
CR 505SETHICAL ISSUES IN RESEARCH3.00 credits
CR 511SThe History of Misconduct in Biomedical Research 3.00 credits
CR 512SFundamentals of Academic Research Administration3.00 credits
CR 515SINTRO TO CLINICAL TRIALS3.00 credits
CR 520SApplications of Clinical Research Biostatistics3.00 credits
CR 525SSCIENTIFIC WRITING & MED LIT3.00 credits
CR 535SCurrent Federal Regulatory Issues in Biomedical Research 3.00 credits
CR 545SPHARMACEUTICAL LAW3.00 credits
CR 555SCOMPLIANCE & MONITORING ISSUES3.00 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 612SFUNDAMENTALS OF COMPLIANCE3.00 credits
CR 614SPharmacotherapy in New Drug R&D3.00 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
CR 633SQUALITY ASSURANCE AUDITS3.00 credits
CR 635SSTRATEGIC PLANNING3.00 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 501S Emerging Trends in Medical Device History - 3.00 credits

The goal of this course is to focus on the various trends that impact the research and development process inherent in the medical device industry. Case studies representing several therapeutic categories will be discussed from a business, medical scientific, ethical, regulatory and bio-medical engineering perspective

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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 512S Fundamentals of Academic Research Administration - 3.00 credits

This course examines the operation of the research administration organization in the academic health care environment. Included will be a series of discussions focusing on the role of administration's leadership, development function, management, and support of the research enterprise in protecting and preserving the institution's interests through the examination of case studies.

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


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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 555S COMPLIANCE & MONITORING ISSUES - 3.00 credits

This course focuses on measuring and improving clinical trial performance as a means of saving time and money, while ensuring quality health care, as well as offering to patients both safe and effective therapeutic products. Students are required to develop milestone efficiencies through the use of process-performance data.

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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 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 614S Pharmacotherapy in New Drug R&D - 3.00 credits

Through the use of selected readings, case studies available from the FDA, and Blackboard discussions, this course will integrate preclinical/clinical research pharmaceutical operations along with federal regulatory approval principles, emphasizing the essentials of pharmacokinetic /pharmacodynamic activity of medications as the sound basis for understanding the clinical application of drug therapy with specific populations.

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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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CR 633S QUALITY ASSURANCE AUDITS - 3.00 credits

This course provides the student with an in-depth knowledge of compliance and quality assurance issues as well as the related regulations inherent in the drug development process. Students develop auditing plans and strategies for conducting compliance inspections.

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CR 635S STRATEGIC PLANNING - 3.00 credits

This course introduces the student to the project management and planning process. Topics include: project communications, leadership, objectives, scope, success criteria, procurement, cost estimating, control mechanisms, developing mission statements and devising strategies that turn vision into reality. May be repeated twice for credit.

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