Studyportals

Clinical Regulatory Affairs

National University

M.Sc.
12 months
Duration
442 USD/module
442 USD/module
Unknown
Tuition fee
Unknown
Unknown
Apply date
Unknown
Unknown
Start date

About

By earning a Master of Science in Clinical Regulatory Affairs (MSCRA) at the National University, you’ll gain a comprehensive knowledge of the field, develop and implement appropriate protocols and documents, and understand data management and the clinical trial research industry.

Overview

Clinical Regulatory Affairs Program at the National University Learning Outcomes

  • Understand the federal regulations in the approval process of a new drug, medical device, or biologic.
  • Have a fundamental knowledge of human rights obligations, adverse events, clinical trial monitoring, and data collection.
  • Develop and implement standard operating procedures, clinical data collection forms, electronic records, clinical trial protocols, and federal regulatory forms.
  • Develop and implement a methodology for a clinical trial with supportive data management and data analysis.
  • Design and implement an investigational device exemption and an investigational new drug application.
  • Develop compliance documents and quality assurance and quality control documentation.

Programme Structure

Courses include:

  • You'll gain a comprehensive knowledge of the field, develop and implement appropriate protocols and documents, and understand data management and the clinical trial research industry. 
  • You’ll also learn how to effectively file for pre-market approval, new drug approval, or biologic license approval.

Key information

Duration

  • Part-time
    • 12 months

Start dates & application deadlines

You can apply for and start this programme anytime.

Language

English

Credits

45 alternative credits

Delivered

On Campus

Academic requirements

We are not aware of any academic requirements for this programme.

English requirements

TOEFL admission requirements TOEFL® IBT The TOEFL iBT® is given online through the internet at designated testing site. The test measures your English-language abilities in an academic setting. The score refers to the total score of 4 subjects (writing, listening, speaking, and reading), each subject has a range of 0 - 30.
79
IELTS admission requirements IELTS The International English Language Test System (IELTS) tests your English-language proficiency on a scale of 1 – 9. The score refers to the combined average score of 4 subjects (writing, listening, speaking, and reading).
6

Other requirements

General requirements

  • Applicants must hold a bachelor’s degree or higher from a regionally accredited college or university where an overall grade point average of 2.5 or better was achieved.
  • Students with a grade point average of 2.0 to 2.49 may be admitted to the University if they have a satisfactory score on one of the following tests: GMAT, GRE, Miller Analogies Test, or an approved, standardized program-specific exam.
  • Students with an undergraduate grade point average of 2.0 to 2.49 may be accepted to National University on a probationary status. 
  • Complete an application for admission and enrollment agreement.

Tuition Fee

  • International

    442 USD/module
    Tuition Fee
    Based on the original amount of 442 USD per module and a duration of 12 months.
  • National

    442 USD/module
    Tuition Fee
    Based on the original amount of 442 USD per module and a duration of 12 months.

cost per quarter unit

Funding

Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

Due for update

Updated over a year ago

Check the official programme website for potential updates.

Our partners

Clinical Regulatory Affairs
-
National University

Wishlist