Date of Award

5-1-2014

Degree Type

Thesis

Degree Name

Master of Science

First Advisor

Patricia A. Gwirtz

Abstract

The primary purpose of this practicum project is to outline the steps a Site Management Organization (SMO) must take in order to successfully reach their enrollment goal as set forth by the CRO or Sponsor. In order to conduct this practicum project, I participated in a 6 month, full-time internship at ACRC trials in Plano, Texas. ACRC Trials is a Site Management Organization (SMO) with 9 years of experience in conducting research in the Dallas area. The acronym for ACRC Trials stands for Advanced Care Research Centers Trials. ACRC Trials handles all aspects of the research process except, those duties which are the sole responsibility of the physician. The duties of the Principal Investigator (PI) include, but are not limited to, performing physical exams, assessing adverse events and laboratory values, and performing any medical procedures. At ACRC Trials, I participated in clinical research topics of regulations, recruiting, and study coordination, with the primary purpose being to outline how ACRC Trials conducts a study with a primary goal reaching their specified enrollment goal. My primary site mentor was Mrs. Heema Marwah, CCRC, who is the Research Director at ACRC Trials.

During my studies at UNTHSC in the Clinical Research Management program, a required course was Introduction to Clinical Research and Studies. In this course students focused primarily on the regulatory documents involved in research and also on roles of specific positions throughout clinical research. During my first few weeks at ACRC Trials, the variation from classroom education to the reality of how research was conducted at my site was evident. For example, I found that many of the operations discussed in the classroom are handled jointly by multiple positions at ACRC Trials, which is different from the rigid discussion of the role and responsibilities of research personnel presented in the classroom. For this practicum project, I used what I observed at ACRC Trials to demonstrate how a team approach may have benefits to the conduct of clinical research compared to separating the responsibilities to individuals. Personnel working closely together at ACRC Trials created accountability and proficiency across many studies at different sites. ACRC Trials has multiple research locations with which they contract and they must ensure that the studies’ strict metrics are achieved within a specific time period at each location. ACRC Trials has a separate regulatory specialist that works with the clinical research coordinators to complete regulatory documents. There are two patient recruiters, one dedicated to recruiting from the research database as well as from marketing campaigns geared towards the community. The other recruiter is dedicated to conducting chart review of the potential subject charts within the practices associated with ACRC Trials, which recruits clinic patients. Once the subjects are screened and scheduled, the subject is seen by the clinical research coordinator. There are a total of four study coordinators that are responsible for their own studies, but they also serve as a backup coordinator for other studies within ACRC Trials. The goal of this practicum project is to 1) demonstrate how to effectively attain subject enrollment goals, 2) focus on two subtopics regarding recent changes in research, and 3) to demonstrate the importance of regulatory affairs and its department at an SMO.

Comments

The Three R’s of Research INTERNSHIP PRACTICUM REPORT Presented to the Graduate Council of the Graduate school of Biomedical Sciences University of North Texas Health Science Center at Fort Worth In partial Fulfillment of the Requirements For the Degree of MASTER OF SCIENCE By Frank Goodman, B.A. Fort Worth, Texas April 2014

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