The Graduate Certificate in Good Clinical Practices 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 CLRA 520 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 trial coordinating and 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.

*ESLN 592 - Professional Healthcare Communication for International Students (3 credits)
Students engage in healthcare topics to further develop the English skills and cultural perspectives necessary for effective communication with staff and patients in healthcare settings. Students will practice written and verbal communications within the ethical and regulatory contexts of drug development and patient interactions. Accent reduction for clarity of communication will be a focus throughout the course.

*ESLN 592 is required for all students entering the CRA Program who require a TOEFL score for admission. The course will be counted toward the credit hour requirement for the MS degree.

The Masters Degree Program requires the completion of a total of 33 - 40 credit hours of instruction. This includes the four didactic courses of the Certificate Program (CLRA510, CLRA520, CLRA,530, and CLRA540), which are all required courses, plus a series of Program and Cognate Elective courses (listed below). 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 (CLRA550) is optional but can be credited as a Program 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
CLRA581, 582, 583 – Regulatory Issues in Drug Development (I, II, III)	HLAD510 – Medical Care Organization
CLRA571 – Grant and Contract Management	HLAD520 - Principles and Theories of Health Care Management
CLRA575 – Ethical Issues in Clinical Research	CLSC501 - Epidemiology
CLRA590, 591, 592 - Special Topics in Clinical Research (topics vary)	BIO 542 – Molecular Genetics
	BIO 548 - Bioinformatics

*additional cognate electives acceptable with permission of Program Director

CLRA 561 - Legal Issues in Drug Development (3cr)
This course will prepare Clinical Research Administrators and others who may be involved in the drug development process in the fundamentals of the patent process and the function of the governmental agencies which supervise the process. Other issues which relate to technology transfer and licensing will also be discussed.

CLRA 571 - Grant and Contract Management for Research Project Administrators (3cr)
This course will prepare future Clinical Research Administrators, and others involved in research administration, in the fundamentals of pre- and post-award management of research projects. Emphasis is given to understanding the terms and conditions of contracts and grant award documents, and to management issues involved in forming and managing sub-contractual relationships.

CLRA 575 - Ethical Issues in Clinical Research (3cr)
This course will focus on the ethical issues which are of concern during the conduct of clinical research. Topics will cover study planning, conduct and information dissemination.

CLRA 581, 582, and 583 - Regulatory Issues in Drug Development (3cr)
This 3 course sequence provides a working knowledge of pharmaceutical regulatory affairs. Emphasis on US development, although topics will include non-US development and the development of biologics, OTC and devices. CLRA 581 focuses on drug discovery through IND submission and clinical development. Issues include portfolio decision-making. CLRA 582 focuses on marketing application (NDAs), labeling, marketing approval and product launch. CLRA 583 addresses post-approval issues including advertising and promotion, drug safety and pricing.

CLRA590 – Special Topics in Clinical Research (1cr)
Special topics in Clinical Research. Topics vary.

CLRA591 – Special Topics in Clinical Research (2cr)
Special topics in Clinical Research. Topics vary.

CLRA592 – Special Topics in Clinical Research (3cr)
Special topics in Clinical Research. Topics vary.

CLRA601 – Seminar (1cr)
Graduate Seminar is an opportunity for students to present and discuss content from the current literature in the area of clinical research, drug and device development, clinical data management  and regulatory affairs.  Students  are required to present the results of their thesis and research projects in the Graduate Seminar.  Students can register for Seminar more than once.

CLRA685 – Research Proposal Development (1cr)
This course provides the opportunity for students to develop a formal proposal for their research project or thesis.  The development process is interactive with a faculty member and leads to the formation of a graduate committee and an approved project or thesis proposal.

CLRA690 – Thesis (1cr)
Students who have an approved thesis proposal may register for this course which provides academic credit for the actual conduct of the research and writing of the thesis.  Registration requires approval of the faculty member.

CLRA691 – Thesis (2cr)
Students who have an approved thesis proposal may register for this course which provides academic credit for the actual conduct of the research and writing of the thesis.  Registration requires approval of the faculty member.

CLRA692 – Thesis (3cr)
Students who have an approved thesis proposal may register for this course which provides academic credit for the actual conduct of the research and writing of the thesis.  Registration requires approval of the faculty member.

CLRA695 – Project (3cr)
Students who have an approved research proposal may register for this course which provides academic credit for the actual conduct of the research and writing of the masters research project.  Registration requires approval of the faculty member.

For further information contact:
Stephen A. Sonstein, PhD
Coordinator, Clinical Research Administration Program
Eastern Michigan University
206E Marshall Building
Ypsilanti, Michigan 48197
734-487-1238 (voice)
734-487-4095 (FAX)
ssonstein@emich.edu
or
CHHS Advising Center
(734) 487-4097
chhsadvising@emich.edu