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.

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