The
Post-baccalaureate Program consists of four
courses which provide information concerning the Drug Development
Process, Good Clinical Practice (GCP), Federal Regulations and
Guidelines (U.S. and international), Clinical Research Protocol
development, implementation and monitoring. Courses are offered
in a format which suits the non-traditional student and allow
the student with a full-time job to complete the courses while
continuing to work. These courses are also an excellent review
for individuals currently employed as Clinical Research Associates
or Study Coordinators. Upon satisfactory completion of the didactic
component of the program, students may apply for admission into
a hands-on preceptorship experience with CRO's, pharmaceutical
firms and clinical facilities which collaborate with the Program.
CLRA
510 - Introduction to Drug Development (3 credits)
This course introduces the student to the pharmaceutical industry
and the process of drug development. Drug Development Phases
1-4 are discussed. The regulatory requirements of the Food and
Drug Administration are reviewed along with the content of the
Investigational New Drug Application (IND), the New Drug Application
(NDA), and the Marketing Authorization Application (international).
The roles of Investigator, Coordinator, Sponsor and Monitor
are discussed. Individuals are exposed to the skills necessary
to function as a successful study monitor.
CLRA
520 - Clinical Study Administration I (3 credits)
This course provides an overview of the development, content
and process of the Clinical Research Study. Topics include protocols,
Case Report Forms, Investigator Brochures, Informed Consent,
Institutional Review Boards and Statement of Investigator Form
1572. Prerequisite CLRA 510 or permission of
instructor.
CLRA
530 - Clinical Study Administration II (3 credits)
This course builds on the content of CLRA 520
and expands upon the processes involved in study management.
The topics include source document verification, visit types,
drug accountability, adverse events, laboratory and supplies.
Prerequisite CLRA 520 or permission of instructor.
CLRA
540 - Advanced Topics in Clinical Study Management (3 credits)
This series of specialized lectures utilizing the background
material presented in CLRA 510 and AHPR520
to develop the concepts of negotiation, presentation, time management,
travel "smarts" as they pertain to the role of clinical
research associate. In addition, information in intellectual
property, post marketing surveillance, record keeping, data
management and data correction techniques are presented. Prerequisite
CLRA 520 or permission of instructor.
Successful
completion of the four courses qualifies an individual for acceptance
into an individualized preceptorship experience where students
work with Clinical Research Associates and Clinical Scientists
in a workplace setting to develop and polish monitoring skills.
The preceptorship may be at one or more of several clinical
sites, CRO's or pharmaceutical firms which have affiliated with
the Program.
CLRA
550 - Preceptorship in Drug Development (3 credits)
The preceptorship is an individualized hands-on experience which
gives the student on-the-job experience in both a clinical setting
where patients are enrolled in clinical trials and a clinical
research organization or pharmaceutical corporation where protocols
are developed, implemented and monitored. Students will interact
with Clinical Research Associates, Clinical Research Coordinators,
and Clinical Scientists in a workplace setting to develop and
polish clinical research coordinating and monitoring skills.
Prerequisite CLRA 540 or permission of the
instructor.
The Masters Degree Program requires the completion
of 33 - 40 credit hours of instruction. The four didactic course
of the Certificate Program (CLRA510, CLRA520, CLRA,530, and
CLRA540) are all required courses. The MS degree also requires
registration at least once in CLRA601 – Graduate Seminar
and the completion of either a thesis or a graduate project.
The preceptorship is optional and but can be credited as an
elective. In addition there are a series of program electives
and cognate electives (see below) which may be used to complete
the credit hour requirement.
| Program
Electives |
Cognate
Electives |
| CLRA561 – Legal Issues in
Drug Development |
NUR590 - Pathophysiology |
| CLRA571 – Regulatory Issues
in Drug Development |
HLAD510 – Medical Care Organization |
| CLRA581 – Grants and Contracts
Management |
|
| CLRA592 – Ethical Issues in
Clinical Research |
OCTH540 – Research Methods |
| |
CLSC590 - Epidemiology |
| |
BIOL542 – Molecular Genetics |
| |
BIOL592 - Bioinformatics |
For
further information contact:
Stephen A. Sonstein, PhD
Coordinator, Clinical Research Administration Program
Eastern Michigan University
318 Marshall Building
Ypsilanti, Michigan 48197
734-487-1238 (voice)
734-487-4095 (FAX)
Stephen.Sonstein@emich.edu
or
CHHS Advising Center
(734) 487-4097
chhsadvising@emich.edu
