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.
AHPR
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.
AHPR
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 AHPR510 or permission of instructor.
AHPR
530 - Clinical Study Administration II (3 credits)
This course builds on the content of AHPR520 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 AHPR520
or permission of instructor.
AHPR
540 - Advanced Topics in Clinical Study Management (3 credits)
This series of specialized lectures utilizing the background
material presented in AHPR510 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 AHPR520 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.
AHPR550
- 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 AHPR540 or permission of the instructor.
The courses in this program are offered year round in a non-traditional
format so that individuals who are currently employed can complete
the program. Courses can be offered by compressed video to a
distant site which has a sufficient number or students.. Please
contact the Program Director for further details.
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
