Date of Award

12-1-2016

Degree Type

Restricted Internship Practicum Report

Degree Name

Master of Science

Field of Study

Clinical Research Management

Department

Graduate School of Biomedical Sciences

First Advisor

Ladislav Dory

Second Advisor

Joseph E. Warren

Third Advisor

Melissa Pool

Abstract

To ensure the highest validity of clinical trials, the safety and efficacy of the investigational products that are used in the studies must be of highest priority. This task is accomplished through the use of a research site’s standard operating procedure.

This practicum study addressed the standard operating procedure for the handling of investigational products at The Center for Cancer and Blood Disorders. A survey was used to assess the knowledge and perception about the standard operating procedure from those that are involved in the handling of investigational products. Information from this survey was used to adjust and make changes to the existing standard operating procedure to better ensure the safety and efficacy of the investigational products that are being studied at the site.

Comments

Dang, Johnny V., Implementation of an Updated Standard Operating Procedure For Investigational Product Management, Master of Science (Clinical Research Management), November 2016. Available worldwide December 2017.

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