Clinical
Investigation
List of Courses
GMS
MS 552 Presenting Data in Biomedicine
Prereq:
Some computer skills and basic understanding of the Internet. Presents
a survey of how personal computers and online computing resources
can be used as a communication tool in a medical/biotechnical research
environment. Topics include communications design, acquisition and
presentation of experimental data, online resources, the role of the
Internet and the Web as research tools, and copyright issues. Hands-on
laboratory assignments and projects include Web site creation (including
basic HTML programming), slide show creation, and Inter-net searches
on specified topics. Abruzzese. 4 cr, 2nd sem.
GMS
CI 630 Introduction to Medical Pharmacology
Prereq:
Premedical courses in the sciences. Principles of pharmacology are
covered and several major classes of therapeutic agents, with attention
to their mechanisms of action. Issues of current and future concern
in medical pharmacology are addressed including problems of drug abuse,
the ethics of human experimentation, the pricing of new drugs, and
new biotechnological approaches to drug design and development. Walsh,
staff. 4 cr, 2nd sem.
GMS
CI 631 Clinical Trials Management
Preq:
GMS CI 675 Design and Conduct and consent of instructor. This course
is an integrative learning experience, combining a comprehensive review
of the good clinical practice core principles with explanation and
analysis of selected portions of the Code of Federal Regulations (CFR),
applicable to clinical research during the new drug development process.
The case study approach is used in this course since the drug development
industry translates these regulations into both written and unwritten
standards, practices, and guidelines. Each session will use activities
to expand the interpretation of the regulations, further integrating
real-life issues into the classroom. In order to ensure that classroom
learning is linked with the students' work experiences, there will
be an outside project required which will incorporate the course work
with the on-the-job situations, and a final presentation to share
the learning with the entire class. Halloran. 4 cr, 2nd sem.
GMS
CI 640 Regulatory and Compliance Issues
Prereq:
Premedical course requirements and consent of instructor. Course
explains the regulatory requirements for healthcare products, that
is, drugs, biologics, diagnostics, and devices. Intended for those
interested in regulatory affairs or in the clinical evaluation,
development, manufacture, testing and/or commercialization of these
products. Provided is an in-depth review of the pertinent FDA regulations
and guidelines and links these to the scientific and logistical
activities involved in taking a product from research to market.
Content and preparation of regulatory submissions, including an
Investigational New Drug Application (IND), an Investigational Device
Exemption (IDE), a New Drug Application (NDA), a Biologic License
Application (BLA), a Pre-Market Approval Application (PMA), and
a 510K PreMarket Notification are described. International requirements
for health care products are also reviewed. Gloff. 4 cr,
1st sem.
GMS
CI 660 Good Clinical Practices in Clinical
Research
Prereq:
Consent of instructor. Introduces regulatory responsibilities of
sponsors, monitors, and investigators conducting clinical trials.
Practical information and exercises are designed on GCP compliance
from an industrial perspective. Topics include: selecting qualified
investigators; obtaining ethical approval for patients, and initiating
sites successfully. Group discussions and guest speakers help students
learn practical skills. Halloran. 4 cr, sum2.
GMS
CI 670 Biostatistics with Computer
Prereq:
Consent of instructor. This course is designed for Clinical Research
Associates and other students with no prior experience with statistics
who want to utilize computer software in performing statistical
analysis. Topics include the collection, classification, and presentation
of descriptive data; the rationale of hypothesis testing; experimental
design; t-tests; correlation and regression analysis; and analysis
of contingency tables. Laboratory course. Rose. 4 cr, 1st
sem.
GMS
CI 675 Design and Conduct of Clinical
Trials
Prereq:
Prior knowledge of statistics is recommended and consent of instructor.
Covers the history and current methodologies used in the design
and conduct of clinical trials. Topics include sample selection,
data forms and management, patient recruitment, enrollment, and
compliance, cost measures and effectiveness. Halloran. 4 cr,
1st sem.
GMS
CI 691, 692 Directed Study for Clinical
Investigation
Var
cr, 1st, 2nd, and summer sem.
GMS
CI 790 Seminar in Clinical Investigation
Prereq:
Consent of instructor. The goal of this course will be to provide
students experience in the reading and evaluation of recent basic
science literature that may be pertinent to the origination and
design of clinical trials. The course will be a seminar format.
It will consist of the evaluation of assigned readings of recent
literature which may be relevant to the treatment of human diseases
and which might be expected to lead to further animal experiments
and to culminate in human trials. This format will provide an opportunity
to learn to critically evaluate basic science literature and to
develop oral presentation skills essential to function as a manager
of clinical trials. Broitman, Franzblau, Moore, O'Bryan. 2 cr,
2nd sem.
GMS
CI 791, 792 Clinical
Investigation Practicum
Var
cr, 1st and 2nd sem. A student would only register for this course
if they plan on using the practicum towards the 32 credit requirement.
Please see your academic advisor to get this approved before you
register for this course.
