CTR 110  Introduction to Clinical Research

This course provides a comprehensive introduction to the clinical research process and its history and evolution. Topics include phase of clinical trials, protection of human subjects, roles of the clinical research teams, and responsibilities of clinical research organizations. Upon completion, students should be able to prepare an organizational chart depicting a typical research team, defining the roles or responsibilities of each member.

Course Hours Per Week: Class, 3; Lab, 0

Semester Hours Credit: 3

Prerequisite: Enrollment in the Clinical Trials Research Associate program or permission of program director

Corequisite: None

CTR 112  Clinical Research Terminology

This course is designed to enhance and augment the student’s knowledge of basic medical terminology. Emphasis is on acronyms, abbreviations, and initials commonly used in clinical research and the terminology associated with pharmaceutical and pharmacological research. Upon completion, students will be able to utilize and apply standard research terminology in effective written and verbal communication.

Course Hours Per Week: Class, 3; Lab, 0

Semester Hours Credit: 3

Prerequisite: CTR 110

CTR 115  Clinical Research Regulations

This course covers the range of national and international regulations governing the development of drugs, diagnostics, medical devices, and biologics. Topics include a review of the regulatory agencies, guidelines for regulatory application, required documentation, and preparation for compliance audits. Upon completion, students should be able to demonstrate a basic understanding of regulatory processes associated with clinical research and describe effective means of compliance.

Course Hours Per Week: Class, 3; Lab, 0

Semester Hours Credit: 3

Prerequisites: CTR 110

Corequisite: None

CTR 120  Research Protocol Design

This course introduces the student to the scientific development of research protocols and their key elements. Topics include the differentiation between research design types, rules for writing protocols, ethical considerations relative to research protocols, and the correct preparation of data collection forms. Upon completion, the student will be able to identify the primary components of protocols and effectively develop a protocol draft.

Course Hours Per Week: Class, 3; Lab, 0

Semester Hours Credit: 3

Prerequisite: Prerequisite: CTR 130

Corequisite: Corequisite: None

CTR 130  Clinical Research Management

This course introduces the student to the elements involved in implementing and managing a clinical study. Topics include overall project planning, development of study goals, preparation of budget and contracts, implementation of monitoring visits, and effective management of research sites. Upon completion, students should be able to design and prepare a plan for the implementation and management of a sample clinical research project.

Course Hours Per Week: Class, 4; Lab, 0

Semester Hours Credit: 4

Prerequisite: None

Corequisite: None

CTR 150  Research Fieldwork I

This course provides supervised work experience and observation in a clinical research setting. Emphasis is on the enhancement of professional skills and the practical application of curriculum concepts in the research setting. Upon completion, students should be able to apply research theory effectively to clinical research practices.

Course Hours Per Week: Class, 0; Lab, 15

Semester Hours Credit: 5

Prerequisites: CTR130, CTR 220 and BIO 169

Corequisite: None

CTR 210  Research Data and Reports

This course covers the organization and management of study data and the effective presentation of data in reports. Topics include database structures, data management systems, quality assurance, data confidentiality and security, key elements of effective reports, and preparation of case report forms. Upon completion, students will be able to organize, enter, and review effectively the data used in the presentation of required reports.

Course Hours Per Week: Class, 3; Lab, 0   

Semester Hours Credit: 3  

Prerequisites: CTR 120

Corequisite: None

CTR 215  Data Management Concepts

This course is designed to discuss the elements involved in implementing and managing a clinical study from the perspective of the Data Manager. Topics include development of the data management plan, coordination of data collection and capture, plan the closure and archival of study materials and participate in project management activities. Upon completion, students should be able to design, prepare and execute a complete data management plan for the implementation and management of a sample clinical research project.

Course Hours Per Week: Class, 2; Lab, 0  

Semester Hours Credit: 2 

Prerequisites: CTR 210

Corequisite: None

CTR 220  Research Site Management

This course covers the guidelines and methodology of research site management and the recruitment of research sites, investigators, and subjects. Topics include the identification and evaluation of sites and investigators, on-site budget management, and the coordination of subject participation. Upon completion, students should be able to demonstrate the principles and practices of effective research site management.

Course Hours Per Week: Class, 3; Lab, 0

Semester Hours Credit: 3

Prerequisite: CTR 115

Corequisite: None

CTR 225  Data Collection

This course is designed to instruct the student on the data collection, validation and quality assurance processes of a clinical research study as conducted by the data management staff. Topics include the development and implementation of data review and data collection, the development of the validation program and the function, conduct and followup of a quality assurance audit of data. Upon completion, students should be able to develop and implement a plan for data collection, validation and quality assurance for a clinical research study.

Course Hours Per Week: Class, 1; Lab, 2

Semester Hours Credit: 2 

Prerequisites: CTR 210, CTR 215

Corequisite: None

CTR 230  Data Trends and Reporting

This course covers the reporting of clinical trial data including identification of safety and efficacy trends in the data. Topics include generation of tables, listing and graphs, the identification and reporting of data trends, and the generation of various types of study reports. Upon completion, students should be able to demonstrate an understanding of the process for review and reporting of clinical trial data results.

Course Hours Per Week: Class, 1; Lab, 2

Semester Hours Credit: 2 

Prerequisites: CTR 210, CTR 215, CTR 225

Corequisite: None

CTR 250  Research Fieldwork II

This course provides more advanced work experience in a clinical research setting. Emphasis is on the refinement of professional skills and the practice of curriculum concepts in diverse clinical research areas. Upon completion, students will be able to apply research theory to clinical practices.

Course Hours Per Week: Class, 0; Lab, 24

Semester Hours Credit: 8

Prerequisite: CTR 150

Corequisite: None

CTR 281  Trends in Clinical Research

This course covers the major issues, trends, and concepts in contemporary clinical research practice. Topics include professional ethics, continuing education and certification, job placement skills, and the latest developments in clinical research. Upon completion, students should be able to demonstrate a basic knowledge of the topics covered.

Course Hours Per Week: Class, 3; Lab, 0

Semester Hours Credit: 3

Prerequisite: CTR 130, CTR 120, CTR 210

Corequisite: None