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Rutgers SHP Requirements for Graduation and Course Descriptions

Department of Health Informatics

Clinical Research Management

BPHE5521 - Regulatory and Ethical Requirements in Clinical Investigations

Course Description

The course presents foundation knowledge of regulatory and ethical requirements impacting the conduct of clinical investigations, most notably intervention studies conducted by the pharmaceutical and device industries. Content focuses primarily on the regions contained in Title 21 of the Code of federal Regulations (CRF) as well as ethical foundation documents, FDA guidance, and the FDA inspectional process. This course expands into a more global view including the history and organization of the International Council on Harmonization (ICH), ICH documents, and introduces students to the European Clinical Trial directives. Students will be exposed to global regulatory processes which ensure information and ethical pharmaceutical development decisions in Japan, Korea, Australia, China, and Southeast Asian countries.

Credits/Modes of Instruction

Credits: 3

This course is a 3 credit, online graduate course provided via the Canvas Platform. The course is taught using a web-based format (directed study) with: Assigned and suggested readings, links to relevant sites on the internet, narrated PowerPoint slideshows, and video recordings, directed discussion activities, Test Your Knowledge activities, written assignments that will assess the students’ achievement of course objectives in understanding the foundation of global clinical trial regulations, laws, and guidances, as well as the evolution of ethical principles used for clinical trials.

Prerequisites

None

Course Goals and Outcomes:

Goals

The goal of the course is to provide an in-depth foundation of laws, regulations, guidelines and ethical aspects applicable to the conduct of clinical investigations supporting new drug approvals including. US centric trial activities include: FDA review processes; Human Subject Protections; Sponsor and Clinical Investigator activities; and Institutional Review Board oversight. Global clinical investigations with also be introduced, with primary focus on ICH guidances, regional laws, and directives.

Outcomes

Outline the history and ethical infractions that led to the regulation of clinical research in the United States; Discuss regulations, guidances, and the regulatory environment that govern the conduct of clinical research in the US and non-US regions; Review the foundation of the International Council on Harmonization (ICH), and discuss US and non-US use of the guidances developed by this organization; Describe the FDA structure and review processes related to investigational drug and device applications; Outline the current regulatory issues that impact global clinical research programs.