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Program checklist · Graduate Certificate

Clinical Research Regulatory Affairs, Graduate Certificate (Boston)

Northeastern University · Boston, MA

A checklist is the list of requirements to complete this program and receive the award, as the college publishes it in its catalog. It is the same for everyone. It does not say what you have completed; that comes from applying your own record.

Program
Award
Graduate Certificate
Credential class
ceterms:Certificate
CIP
51.2002
Catalog edition
Catalog 2026-2027
Checklist type
degree-program
Description
The Graduate Certificate in Clinical Research Regulatory Affairs offers students an opportunity to develop a comprehensive understanding of continuously and rapidly evolving clinical research global biomedical product regulatory standards and processes. Credits earned in this certificate may be used to satisfy some of the degree requirements of the Master of Science in Regulatory Affairs program, which develops the professional competencies required to ensure regulatory processes for new biomedical products are conducted in compliance with global standards and regulatory agency requirements. Such clinical global standards and regulatory processes are separate and distinct from those applicable to the indirect, non-patient-facing development of biomedical products, including in vitro design work , in vivo animal testing, in silico testing, and manufacturing process validation.
Identifiers
IPEDS UNITID
167358
CourseShelf checklist
CK_167358_b31abc33
CollegeTransfer.Net
Institution Transfer Profile
Source
CourseShelf publish 61

Requirements to complete

Every course or condition the catalog lists, in the catalog's order.

Required Courses

4 items
  1. RGA 6600
    Introduction to Food and Drug Administration Pharmaceutical Regulation
    Not resolved to a course
    or: RGA 6610 Introduction to Food and Drug Administration Medical Device Regulation
    3
  2. RGA 6285
    Validation and Auditing of Clinical Trial Information
    Not resolved to a course
    3
  3. RGA 6290
    Clinical Trial Design Optimization and Problem Solving
    Not resolved to a course
    3
  4. RGA 6295
    Managing International Clinical Trials
    Not resolved to a course
    3
Source. Northeastern University, catalog Catalog 2026-2027 — https://catalog.northeastern.edu/graduate/professional-studies/graduate-certificate-programs/clinical-research-regulatory-affairs-graduate-certificate-bos/. Captured page pages/0447.html.gz. Assembled from the institution's published catalog as captured; every record names its captured page and source URL. Assembled, not asserted.