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. The student should also be able to describe the product approval process and discuss the general conduct of a typical clinical trial.
Course Hours Per Week: Class,
3; Lab, 0
This course is designed to enhance and augment the studentís 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.
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.
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.
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.
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.
This course covers the collection, organization, and management of study data. Topics include database structures, data management systems, quality assurance, data collection and capture, and data confidentiality and security. Upon completion, students should be able to describe the data management team and effectively organize, enter, and review data.
Course Hours Per Week: Class, 3; Lab, 0
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.
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.
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.
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.
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.
This course includes communication skills and professional skills essential to the practice of clinical research. Topics include professional ethics and deportment, continuing education and certification, career options, communication skills, and portfolio development. Upon completion, students should be able to demonstrate the communication and professional skills to enter the clinical research workforce and to establish a career plan.