WRTG 5840 - Regulatory Writing

Institution:

University of Utah

Subject:

Writing and Rhetoric Studies

Description:

Until the twentieth century, there was little regulation for medical interventions. Today, pharmaceutical and medical device companies must go through processes to assure their products are beneficial to the public. Part of that process involves medical writers who work with teams of physicians, clinicians, and engineers to develop the documents for government approval. This class takes you through the regulatory process, from research design to communicating the results to the public. Documents you will learn to write include study protocols, informed consent documents, clinical study reports, the investigator's brochure and a plain language summary of the study findings and benefits and risks. At the end of the class, you should have a document that will be useful for your job portfolio.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Seminar

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.utah.edu

Phone Number:

(801) 581-7200

Regional Accreditation:

Northwest Commission on Colleges and Universities

Calendar System:

Semester

General Education

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