Date of Award

5-1-2016

Degree Type

Internship Practicum Report

Degree Name

Master of Science

Field of Study

Clinical Research Management

Department

Graduate School of Biomedical Sciences

First Advisor

Patricia A. Gwirtz

Second Advisor

Heema Marwah

Third Advisor

Michael B. Gatch

Abstract

Meeting enrollment goals in clinical research trials has become increasingly more difficult due to heightened regulations and more stringent study protocols. This practicum report explores some of the reasons why sponsors in clinical research trials occasionally need to enlist the aid of investigative add-on sites, and highlights some of the unique opportunities that are presented to prospective add-on sites. Advanced Care Research Centers (ACRC) Trial’s current involvement in a contraceptive study, as an investigative add-on site, provides this report with a case study, where observations and the analysis of enrollment data can appraise their success as an add-on site. Past trials are also assessed in order to supplement other themes raised in this discussion.

Comments

Arbov, Eli, Sponsor Accrual of Investigative Add-On Sites. Masters of Science (Clinical Research Management), December 15, 2015, 74 pp., 4 figures, 1 table, bibliography, 10 titles. Available worldwide May 2017.

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