CTA 5400 - Clinical Study Administration II

Institution:

Western Michigan University

Subject:

Description:

The course builds on the content of Clinical Study Administration I and presents the steps necessary to initiate, monitor, and close clinical trials within the context of Food and Drug Administration (FDA) regulations, Canadian Health Protection Branch regulations, and International Conference on Harmonization guidelines for Good Clinical Practices. Topics include: study monitoring, source document review, drug and device distribution and accounting, data correction and management, adverse event reporting, auditing and preparing for FDA inspection, Data review and summaization and final study reports. Prerequisites & Corequisites: Prerequisite: CTA 5300. Credits: 3 hours

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.wmich.edu

Phone Number:

(269) 387-1000

Regional Accreditation:

North Central Association of Colleges and Schools

Calendar System:

Semester

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