Center for Curriculum and Transfer Articulation
Major: 5161
First Term: 2012 Summer I   
Award: CCL  
Total Credits: 26
CIP Code: 51.0719

Occupational Area: Human Services / Social Sciences
Instructional Council: Allied Health (51)
GPA: 2.00
SOC Code:

Description: The Certificate of Completion (CCL) in Clinical Research Coordinating program is achievable within a 12-24 month period. Required coursework covers research study management, project activities, subject coordination, and regulatory documentation and administration. The program focus is on the achievement of behavioral competencies and technical skills for Clinical Research Coordinators (CRC) including research site preparation; subject screening, enrollment, recruitment, and follow-up visits; maintenance and dispensing of drug supplies; completion of case report forms and regulatory documents; and the adherence to Good Clinical Practice guidelines.

The Clinical Research Coordinating program is taught in accordance with standards of the Society of Clinical Research Associates (SoCRA) and the Association of Clinical Research Professionals (ACRP) for their nationally and internationally recognized CRC certification examinations. Course components such as research ethics and Institutional Review Board operations, are based on the standards and guidelines of the Public Responsibility in Medicine and Research (PRIMR).

Consumer Program Costs and Career Information

Required Courses
+ CRC200 Legal and Regulatory Research Compliance 4
+ CRC210 Research Design and Data Management 4
+ CRC225 Clinical Research Site Budget Process 2
+ CRC240 Research Ethics 3
+ CRC250 Clinical Research Site Management 4
+ CRC255 Introduction to Medical Devices in Clinical Evaluation 2
+ CRC270 Institutional Review Board in Clinical Research 3
Credits: 22

Program Competencies
1. List the Food and Drug Administration (FDA) requirements for sites participating in clinical trials. (CRC120, CRC250)
2. Differentiate among the five major regulatory bodies governing human subject research. (CRC200)
3. Complete sample federal form 1572, "statement of Investigator" and addendums for conflict of interest for a clinical research site. (CRC200, CRC210, CRC250)
4. Explain the operational preparations required for a regulatory site audit. (CRC200, CRC210, CRC250)
5. Identify physical and non-physical risks associated with research subjects. (CRC200, CRC240)
6. Identify ethical issues of using vulnerable populations in research. (CRC200, CRC240)
7. Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt criteria approvals. (CRC200, CRC270)
8. Analyze the ethical and moral conflicts between local communities and research initiatives. (CRC200, CRC270)
9. List the documents required for a clinical research site regulatory binder. (CRC210)
10. Identify required research protocol components. (CRC210)
11. Compare and contrast a clinical study case report form designs and production formats. (CRC210)
12. Describe the documents needed for an IRB new protocol review application. (CRC210, CRC270)
13. Prepare a sample study budget for a clinical trial. (CRC225, CRC250)
14. Practice moral reasoning in scientific research. (CRC240)
15. Summarize at least three confidentiality issues with genetic research. (CRC240, CRC270)
16. Prepare basic quality assurance procedures for a research site. (CRC250)
17. Differentiate responsibilities of the IRB, the principal investigator, and the sponsor in the conduct of an investigational device study. (CRC255)
18. Define significant risk (SR) and non significant risk (NSR) and explain the role of the IRB, the FDA and the sponsor in determining this status. (CRC255)
19. Compare and contrast the routes to market for device manufacturers, including premarket approval (PMA), substantial equivalence, exemption from 510k, extension of a product line, reclassification and humanitarian use. (CRC255)
20. Differentiate at least four legal issues facing IRBs. (CRC270)
MCCCD Governing Board Approval Date: February 28, 2012

All information published is subject to change without notice. Every effort has been made to ensure the accuracy of information presented, but based on the dynamic nature of the curricular process, course and program information is subject to change in order to reflect the most current information available.