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.
Course Descriptions
CR 500 - Epidemiology
This course will introduce students to the principles and concepts of epidemiology emphasizing methods for assessing factors associated with the distribution and etiology of patient care, disease and prevention in the clinical research setting and the health care marketplace.
CR 501S - Emerging Trends in the Medical Device Industry
The goal of this course is to focus on the various trends that impact on 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.
CR 505S - Ethical Issues in Research
Students will explore ethical issues important to sound clinical research, review the foundations of regulations for clinical investigations, and come to better understand the operational imperatives of Good Clinical Practices.
CR 511S - The History of Misconduct in Biomedical Research
This course will explore, through a broad variety of case studies, the history of misconduct; the different types and the incidences, along with probing the motivation for it. This course will also examine how the Federal regulatory agencies such FDA, ORI, and OHRP exact legal penalties for misconduct and fraud in the biomedical research setting.
CR 512S - Fundamentals of Academic Research Administration
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.
CR 515S - Introduction to Clinical Trials
This course will provide the student with an opportunity to learn and understand the regulatory and scientific rationale of designing, conducting, and successfully completing a clinical trial. Also, the essential documents required to conduct a clinical trial will be introduced along with critical issues to be considered when designing a protocol for a clinical study. This course is vital to understanding and applying the principles and practices for designing and conducting a quality research program within the prescribed federal regulatory framework.
CR 520S - Applications of Clinical Research Biostatistics
This course includes a discussion of the concepts and language of statistics necessary to facilitate an understanding of the various statistical issues required in designing and analyzing a clinical trial, as well as how to effectively communicate the results of the trial. The basic methods of describing data, fundamentals of probability, simple models and methods of parameter estimation and inference will be discussed.
CR 525S - Scientific Writing and the Interpretation of Medical Literature
This course will examine the rhetorical and scientific principles involved in writing for the sciences using narrative structures, theories of discourse, linguistic principles, and fundamental biomedical and scientific data. In addition, this course will show students how to research and evaluate information, summarize and organize clinical / technical data, and prepare concise and lucid documents within the constraints of regulatory and other procedural requirements.
CR535S - Current Federal Regulatory Issues in Biomedical Research
This course will review current issues in pharmaceutical regulation under current consideration by policymakers and how issues outside of research affect healthcare and new product development activities.
CR 545S - Pharmaceutical Law in R&D
This course will introduce several legal and regulatory principles and practices under the Federal Food, Drug and Cosmetics Act governing the research and development of pharmaceuticals and biologics in human and animal research. Students will analyze legal and social constructs affecting industry and the academic clinical investigator, with particular attention on FDA regulatory and enforcement actions. Pharmaceutical law will provide the backdrop for the majority of courses in the CROM program.
CR 560S - Special Topics
With the approval of the academic director for the CROM program and a faculty member for which the topic of the paper is relevant, the student will select a topic for a research paper related to an aspect of one of the five curriculum tracks.
CR 565S - Contemporary Issues in Human Research Protection
This course will examine and analyze various case-based topics focusing on specific ethical policies, federal regulations, and the legal practices of quality clinical research with particular attention paid to the institutional review board, the informed consent process, and common mechanisms in place to ensure the adequate protection of the human research participant.
CR 570S, Principles and Practice of Pharmacovigilance
This course will review historical and contemporary safety reporting parameters, as well as pre-approval clinical testing and will examine the various agencies assessing and monitoring risk management, real-world issues and controversies in order to understand the importance of drug safety.
CR 600S - Designing the Clinical Trial
The design, ethical, clinical, and strategic issues surrounding clinical drug research is 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.
R 609S - Innovative Product Development
This course focuses on the process of drug development from early research to discovery and finally to product formulation, all the while considering the federal requirements for proving safety and efficacy. To demonstrate the application of these goals, the student will be expected to develop a business profile of a company.
CR 612S - Fundamentals of Compliance
This course will review the values and responsibilities of the clinical investigator as they relate to the discipline of science and to society beyond clinical research. There will be a fundamental integration of the concepts necessary for the responsible conduct of research, its subject matter and understanding, including such topics as research integrity, environmental and safety issues, institutional and organizational fiscal contractual accountability, and the development of the clinical trial site budget.
CR 614S - Applications of Pharmacotherapy in Research and Development
This course will integrate and discuss the relationship between preclinical/clinical research pharmaceutical operations and 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 within specific populations.
CR 617S - Informatics in Research and Development
This course will examine past, as well as present contributions of computer applications to pharmaceutical R&D by using a combination of printed materials, case studies, literature reviews, and on-line discussions.
CR616S - The Introduction of Therapeutic Products
This course provides an overview of medical marketing practices and key strategies used by the pharmaceutical industry in the introduction of therapeutic products, focusing on the interface between drug/product development and the marketing process.
CR 620S - Principles, Practice, and Regulation of Biotechnology
This course will provide an overview of the history of biotechnology and the fundamental scientific concepts for developing marketable medical therapeutic products through the integration of science and marketing.
CR 625S, Health Policy and Economics
This course will begin with an exploration of the dynamic environment of health care and the processes of healthcare delivery in the managed care environment. Also, there will be a review of cost containment practices and the economic methodologies employed to evaluate the cost effectiveness of healthcare services. Cost effectiveness will be examined in terms of outcome assessments and quality-of-life measurements.
For additional information on the program, please contact:
Sara J. Perkel, MBA
Director, Graduate Clinical Research
Education
Drexel University College of Medicine
Sara.Perkel@DrexelMed.edu
Withdrawals*
If the effective date of the Withdrawal falls:
- Before the start of classes, all charges will be removed and no tuition or fees will be due.
- First 15 days of the semester, all charges will be removed and no tuition or fees will be due.
- From day 16 to day 30 of the semester, tuition and fees will be reduced by 50%.
- From day 31 to day 45 of the semester, tuition and fees will be reduced by 25%.
- After 45 days of the semester, there is no reduction in the tuition and fees. Students may withdraw 45 days from the start of a course and will receive a "W" on their transcript.
*This pertains to Clinical Research Organization and Management semesters.
