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Center for Curriculum and Transfer Articulation
Major: 5901
Effective Term: 2024 Spring   

Award: CCL  
Total Credits: 29-30
CIP Code: 51.0719
Instructional Council: Allied Health
GPA: 2.00
SOC Code: Upon completion of this certificate, students may pursue a career as:
11-9121.01 Clinical Research Coordinators


Description: The Certificate of Completion (CCL) in Clinical Research Coordination requires coursework which covers research investigation site management, study coordinator related activities, subject participation 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 essential documentation identification and preparation; subject screening, enrollment, recruitment, and follow-up visits; maintenance, dispensing and documentation of investigational product; completion of case report forms and ancillary regulatory documents; and the adherence to International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.

Program Competencies
1. Design a clinical trial (identify the components of a clinical trial protocol). (CIS114DE, CRC103, CRC151, HCC145, HCC146)
2. Differentiate among the five major regulatory bodies governing human subject research. (CRC102)
3. Describe the role and process for monitoring of the study. (CIS114DE)
4. Identify ethical issues of using vulnerable populations in research. (CRC102, CRC152, HCC145, HCC146)
5. Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt studies. (CRC101, CRC102, CRC153)
6. Differentiate the types and identification process of adverse events (AEs) which occur during clinical trials and the reporting requirements to IRBs, Ethics Committees, other regulatory authorities, and sponsors. (CIS114DE, CRC152, CRC153, HCC145, HCC146)
7. Apply management concepts and effective training methods to manage risk and improve quality in the conduct of a clinical research study. (CIS114DE, CRC152)
8. Identify required research protocol components. (CIS114DE, CRC101, CRC103, HCC145, HCC146)
9. Explain the evolution of the requirement for informed consent from research participants and the principles and content of the key document which ensure the protection of human participants in clinical research. (CIS114DE, HCC145, HCC146)
10. Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards. (CRC101, CRC152, HCC145, HCC146)
11. Prepare a sample study budget for a clinical trial. (CIS114DE)
12. Practice moral reasoning in scientific research. (HCC145, HCC146)
13. Summarize at least three confidentiality issues with genetic research. (CRC152, HCC145, HCC146)
14. Summarize the legislative and regulatory framework which supports the development and registration of medicines, devices and biological and ensures their safety, efficacy and quality. (CRC102, HCC145, HCC146)
15. Prepare basic quality assurance procedures for a research site. (CIS114DE, CRC160)
16. Differentiate responsibilities of the IRB, the principal investigator, and the sponsor in the conduct of an investigational device study. (CRC153)
17. 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. (CRC153, HCC145, HCC146)
18. 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. (CRC151, CRC152)
19. Differentiate at least four legal issues facing IRBs. (CRC153)
Program Notes
Students must earn a grade of C or better in all courses within the program.


Required Courses
CIS114DE Excel Spreadsheet 3
CRC101 Introduction to Clinical Research 4
CRC102 Clinical Research Regulations 4
CRC103 Research Design and Data Management 4
CRC151 Introduction to Medical Devices in Clinical Evaluation 2
CRC152 Research Ethics 3
CRC153 Institutional Review Board in Clinical Research 3
CRC160 Clinical Research Site Management 4

HCC145 Medical Terminology for Health Care Professionals (3) OR
HCC146 Common Medical Terminology for Health Care Professionals (2) 2-3
 Credits: 29-30

+ indicates course has prerequisites and/or corequisites.
++ indicates that any suffixed course may be selected.
MCCCD Governing Board Approval Date: February 27, 2024

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.





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