Lifelong Learning for a Brighter World

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Applied Clinical Research

Imagine Better Health.

Your key to entering the rewarding field of clinical research.

Course Descriptions

Students must complete all five courses (15 Units) in order to qualify for the Certificate in Applied Clinical Research.

Students are given a three-year period to complete all required components of the certificate program. This requirement is based on the need to remain current with legal, regulatory and ethical considerations in the field of work.

Each course will bridge theory and practical experience through a combination of experiential learning (i.e. case studies, discussions, and presentations) and traditional teaching methods. There will be considerable emphasis on the application of content in each course to ensure students are well prepared for employment in this field. In addition, students will complete a capstone course as the final course in the program, which provides a concentrated opportunity to apply the clinical research methods, techniques and strategies to industry situation/case. Emerging trends, theories and practices will be incorporated into coursework to ensure that program content is current and relevant.

ACR 101 1. Principles of Clinical Research (3 Units)

This introductory course explores the terminology, as well as roles and responsibilities involved in a clinical research project. Good Clinical Practice (GCP) procedures will be examined, as well as an overview of legal considerations of clinical trials. Emphasis will be placed on the foundational skills needed for successful trial management including project management and communication skills.

ACR 102 2. Research Ethics (3 Units)

Professional guidelines and codes of ethics that apply to the conduct of clinical research will be analyzed. Situations presenting ethical dilemmas including vulnerable populations will be explored as well as scientific integrity, and the responsibilities of the clinical investigation team as defined by GCP guidelines.

ACR 103 3. Clinical Trial Design (3 Units)

Scientific and statistical concepts related to the design and analysis of clinical trials will be examined, as well as the regulatory framework and guidelines that govern clinical trials. Emphasis will be placed on the concepts in the design of a clinical trial including the process of protocol development and effective use of Case Report Forms.

Prerequisite: Principles of Clinical Research, Research Ethics

ACR 104 4. Clinical Trials Management (3 Units)

Strategies for conducting and managing clinical trials, as well as operational issues of a clinical research project will be examined. Effective methods for organizing data and quality assurance will be explored as well as end of trial practices, safety reporting, and the preparation of scientific documents. Topics in leadership will also be examined including management of resources, risk and professional conflicts.

Prerequisite: Principles of Clinical Research, Research Ethics, Clinical Trail Design

ACR 105 5. Clinical Research Capstone (3 Units)

This course is intended to simulate a real-world experience that offers an applied synthesis of learning in the areas of clinical research protocols, and study and site management principles. Participants will also be expected to demonstrate a solid grasp of competencies in leadership, and communication skills that are also needed to ensure a successful clinical trial.

This course is designed to offer students the opportunity to apply the theoretical knowledge and skills gained from the Applied Clinical Research program to a capstone project.

Prerequisite: Principles of Clinical Research, Research Ethics, Clinical Trail Design, Clinical Trials Management (co-requisite - ACR 104 & ACR 105 may be taken simultaneously)