Clinical Data Coordination

The Certificate of Completion (CCL) in Clinical Data Coordination provides students an understanding of the steps involved in clinical data management from study site planning, preparation, data extraction for analysis, reporting of clinical trials, with emphasis on tracking deadlines and milestones. Courses include competencies in design and development of databases, maintenance of required documentation, standard operating procedures (SOPs), and quality control. In addition, the Clinical Data Coordination program ensures compliance with data security and confidentiality, federal laws and regulations in the conduct of research. Students will gain substantive knowledge in how to monitor clinical trials; as well as when, why, and how to engage clinical research organizations (CROs).

Details

Field of Interest
Health Sciences
Degree Type
Certificate of Completion (CCL)
Academic Plan
Clinical Data Coordination (CER)
Academic Plan Code
5903
Total credits required
18-19
Catalog Year
2023-2024
Effective Term
Fall 2023
Admissions criteria

1. Formal application to the Clinical Data Coordination program or Clinical Research Coordinator program.
2. Formal admission to the Clinical Data Coordination program or Clinical Research Coordinator program.
3. Background Check Requirements: Admission to an Allied Health program requires that students be in compliance with the Maricopa County Community College District Background Check standards. Upon conditional program enrollment, the student must comply with all requirements of the MCCCD background check policy.
4. Clinical Health and Safety requirements must be met. Upon conditional program enrollment, the student must comply with all requirements of the MCCCD clinical health and safety policy.
5. Inability to comply with Background Check requirements and/or Clinical Health and Safety requirements at the start of classes may result in cancellation of enrollment for the research clinical experience.

Notes

Students must earn a grade of C or better in all courses within the program.

What You'll Learn

This pathway map will help you gain the expertise needed to:

  1. Demonstrate general understanding of the `Common Rule` and requirements for sites and sponsors participating in clinical trials.
  2. Describe the roles and responsibilities of the clinical investigation team as defined by Good Clinical Practice Guidelines.
  3. Describe how global regulations and guidelines assure human subject protection and privacy during the conduct of clinical trials.
  4. Discuss the historical events and ethical issues impacting vulnerable populations which precipitated the development of governmental regulatory processes for drugs, devices and biologicals.
  5. Complete sample, "Statement of Investigator Federal Form 1572" and addendums for conflict of interest for a clinical research site.
  6. Explain the operational and data preparations required for a regulatory site audit and its purpose.
  7. Identify physical and non-physical risks associated with research subjects.
  8. Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt studies.
  9. Analyze the ethical and moral conflicts between local communities and research initiatives.
  10. List the documents required for a clinical research site regulatory binder.
  11. Compare and contrast a clinical study case report form designs and production formats.
  12. Describe the required protocol components documents needed for an IRB new protocol review application.
  13. Summarize the legislative and regulatory framework which supports the development and registration of medicines, devices and biological and ensures their safety, efficacy and quality.

Successful completion of this certificate may lead to employment in a variety of different occupations and industries. Below are examples of related occupations with associated Arizona-based annual median wages* for this program. Education requirements vary for the occupations listed below, so you may need further education or degrees in order to qualify for some of these jobs and earn the related salaries. Please visit with an academic advisor and/or program director for additional information.

* Wage information sourced from the Bureau of Labor Statistics, Occupational Employment Statistics Program. Updated May 2022.

Course Sequence by Term

The following is the suggested course sequence by term. Please keep in mind:

  • Students should meet with an academic advisor to develop an individual education plan that meets their academic and career goals. Use the Pathway Planner tool in your Student Center to manage your plan.
  • The course sequence is laid out by suggested term and may be affected when students enter the program at different times of the year.
  • Initial course placement is determined by current district placement measures and/or completion of 100-200 level course and/or program requirements.
  • Degree and transfer seeking students may be required to successfully complete a MCCCD First Year Experience Course (FYE) within the first two semesters at a MCCCD College. Courses include FYE101 and FYE103. Course offerings will vary by college. See an academic, program, or faculty advisor for details.

Full-time Sequence

Full-time status is 12 credits to 18 credits per semester.

Term 1

A sequence of suggested courses that should be taken during Term 1
Course Number Course Name Requisites Notes Area Credits
CIS114DE Excel Spreadsheet 3
CRC101 Introduction to Clinical Research 4
CRC102 Clinical Research Regulations 4
HCC145 or
HCC146
Medical Terminology for Health Care Professionals or Common Medical Terminology for Health Care Professionals 2–3

Term 2

A sequence of suggested courses that should be taken during Term 2
Course Number Course Name Requisites Notes Area Credits
CRC103 Research Design and Data Management 4
CRC104 Clinical Data Coordination Practicum I 1
Disclaimer

Students must earn a grade of C or better in all courses within the program.

Course Sequence total credits may differ from the program information located on the MCCCD curriculum website due to program and system design.

View MCCCD’s official curriculum documentation for additional details regarding the requirements of this award (https://aztransmac2.asu.edu/cgi-bin/WebObjects/MCCCD.woa/wa/freeForm11?id=180665).

At Maricopa, we strive to provide you with accurate and current information about our degree and certificate offerings. Due to the dynamic nature of the curriculum process, course and program information is subject to change. As a result, the course list associated with this degree or certificate on this site does not represent a contract, nor does it guarantee course availability. If you are interested in pursuing this degree or certificate, we encourage you to meet with an advisor to discuss the requirements at your college for the appropriate catalog year.