Regulatory and Clinical Research Management, DPP
Compliance, Global, Management, Quality, REGULATORY, Regulation, Regulations, Research, clinical, operations
Prepare to address the complex landscape of the global research industry. This flexible, fully online program offers you the opportunity to pursue a world-class education, taught by innovative faculty and professionals, while you continue to advance in your career.
The Doctor of Professional Practice program in regulatory and clinical research management prepares you to influence the medical and health care industry through the development of new medical products such as drugs, biologics, vaccines and devices to address the health needs of consumers.
An interdisciplinary curriculum weaves innovation, technology, bioinformatics, policy, leadership methods and strategies with regulatory and clinical research management to ensure that you meet industry workforce needs and are a capable, high-functioning, innovative leader. Core courses provide a strong foundation in leadership and communication; the regulations and development of medical products through the life cycle; quality control; application of ethics to animal and human research; pharmacology, drugs and society; biologics; and small molecules. Other topics include the principles and concepts of innovation, systems thinking in a complex environment, artificial intelligence and business. These core courses are balanced with offerings from other ASU colleges and departments, providing you with the knowledge base, skills and abilities to tackle practical health concerns and ethical dilemmas; navigate the global regulatory landscape; and contribute to the discovery medical products, procedures and diagnostics to advance health care.
- College/school:
Edson College of Nursing and Health Innovation
- Location: Online
- STEM-OPT extension eligible: No
60 credit hours including the required applied project course (RCR 793)
Required Core (24 credit hours) Other Requirements (3 credit hours) Electives (21 credit hours) Culminating Experience (12 credit hours) Additional Curriculum Information Students should consult with the academic unit for the list of open electives and restricted electives.
RCR 710 Leadership Communication in the Regulatory and Clinical Research Industry (3)
RCR 712 Leadership for Change in Regulatory and Clinical Research (3)
RCR 713 Quality Control and Assurance Through the Medical Product Cycle (3)
RCR 714 Ethical and Regulatory Aspects of Clinical Research (3)
RCR 715 Drugs and Society: Milestones in Drug Development (3)
RCR 716 Development and Manufacturing of Small Molecules (3)
RCR 717 Development and Regulation of Biologics (3)
RCR 718 Planning and Execution of Clinical Research (3)
NUR 617 Foundational Concepts in Science and Statistics (3)
RCR 793 Applied Project (12)
With approval from the student's supervisory committee and the Graduate College, 15 credit hours from a previously awarded master's degree can be used for this program.
General university admission requirements:
All students are required to meet general
university admission requirements.
U.S.
applicants | International
applicants | English
proficiency
Applicants must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.
Applicants must have earned a master's degree in regulatory science or clinical research management, or a similar degree in a related field from a regionally accredited institution.
Applicants must have a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in an applicable master's degree program.
Applicants are required to submit:
- graduate admission application and application fee
- official transcripts
- personal statement
- professional resume
- two letters of recommendation
- proof of English proficiency
Additional Admission Information
An applicant whose native language is not English must provide proof of English proficiency regardless of their current residency.
Interested students must have a master's degree.
ASU offers this program in an online format with multiple enrollment sessions throughout the year. Applicants may view the program’s ASU Online page for program descriptions and to request more information.
| Session | Modality | Deadline | Type |
|---|---|---|---|
| Session A/C | Online | 07/15 | Final |
| Session A/C | Online | 03/15 | Priority |
Program learning outcomes identify what a student will learn or be able to do upon completion of their program. This program’s learning outcomes include the following:
- Critically evaluate the literature of the field of Regulatory and Clinical Research Management.
- Conduct applied research resulting in an original contribution to knowledge in the focused areas of their graduate program.
- Apply principles of organizational management and leadership, as well as following FDA and international regulations, when writing a business proposal for the development and approval of new medical products.
The life sciences industries provide an array of career opportunities for professionals with doctorate degrees. Technological advances such as AI and machine learning may advance the development and approval of new products to market. Both regulatory and clinical research management personnel are an integral part of this process. Directors and managers in regulatory affairs manage the regulatory aspects of the product through all phases of development, approval and postapproval. Professionals in clinical trial management positions are responsible for the planning, oversight and execution of study and program-level deliverables, managing high-performing teams in a fast-paced environment.
Career opportunities include:
- clinical data manager
- clinical operations director or manager
- compliance officer or manager
- director or manager of quality control
- director or manager of quality management
- director or manager of postmarket quality
- program or project director manager
Edson College of Nursing and Health Innovation
|
HLTHN 301
dpp@asu.edu
602-496-0937
Admission deadlines
Program term definitions
Accelerated programs allow students the opportunity to expedite the completion of their degree.
Accelerated master's
These programs allow students to accelerate their studies to earn a bachelor's plus a master's degree in as few as five years (for some programs).
Each program has requirements students must meet to be eligible for consideration. Students typically receive approval to pursue the accelerated master's during the junior year of their bachelor's degree program. Interested students can learn about eligibility requirements and how to apply.
Concurrent degrees allow students to pursue their own personal or professional interests, earn two distinct degrees and receive two diplomas. To add a concurrent degree to your existing degree, work with your academic advisor.
Joint programs, or jointly conferred degrees, are offered by more than one college and provide opportunities for students to take advantage of the academic strengths of two academic units. Upon graduation, students are awarded one degree and one diploma conferred by two colleges.
ASU adds new programs to Degree Search frequently. Come back often and look for the "New Programs" option.
ASU Online offers programs in an entirely online format with multiple enrollment sessions throughout the year. See https://asuonline.asu.edu/ for more information.
The Western Regional Graduate Program (WRGP) provides a reduced tuition rate to non-resident graduate students who qualify. Visit the WRGP/WICHE webpage for more information: https://graduate.asu.edu/wiche.

