Graduate Certificate in Clinical Trials Management

The Graduate Certificate in Clinical Trials Management was conceived and designed by pharmaceutical, biotechnology and contract research organization experts working in the clinical research field. The program, which is offered completely online, focuses on the fundamentals of the clinical trials environment, study design, and management. This 12-credit program transfers easily into a MSAST Degree in Clinical Trials Management degree program at Thomas Edison State College.

Graduate Certificate in Clinical Trials Management Credit Distribution

Required courses Credits
CTM-510 Introduction to Clinical Trials Research and Drug Development 3
CTM-520 Clinical Trials Research: Practice to Policy 3
CTM-530 Introduction to Clinical Trials Data Management 3
CTM-540 Ethical Issues and Regulatory Principles in Clinical Trials 3
Total 12

Graduate Certificate in Clinical Trials Management Course Descriptions

CTM-510: Introduction to Clinical Trials Research and Drug Development (3 credits)
This course provides an introduction to the field of clinical research and an overview of the environment, FDA approval processes and regulations and various elements involved in the development and conduct of clinical trials. Students identify the history and principles of the drug development process and their application to the design and implementation of clinical research activities. Students identify the steps involved from drug discovery to market approval in the U.S. and abroad. In addition, students learn the role, responsibilities and inter-relationships of regulatory agencies, sponsors, study personnel and other related groups in the clinical research process. The relevant ethical principles developed for the protection of human research subjects and the related elements of informed consent are covered.
CTM-520: Clinical Trials Research: Practice to Policy (3 credits)
This course provides students with an understanding of clinical research methods as well as current issues concerning drug and device development in the United States. Students learn how to formulate a scientific literature search to inform their research efforts and develop the skills that are necessary for critical evaluation of published studies. The design of clinical research is discussed in detail so that the student is prepared to recommend what type of study is best suited for answering particular research questions. Students learn about the various approaches to conducting a survey as a part of clinical research. Economic/cost measures, health-related quality-of-life measures, and work productivity measures are also covered. Students develop an understanding of current issues related to clinical research.
CTM-530: Introduction to Clinical Trials Data Management (3 credits)
This course provides an overview of the clinical data management process in pharmaceutical research settings. Students gain an understanding of the regulations governing the data management process; identify the roles and responsibilities of personnel involved in the research process; learn how and why data is collected and understand database structure and design. The course covers the reporting of adverse drug events. Also covered are parameters for data review, coding, queries and validation. Students develop strategies to manage practical issues that may arise.
CTM-540: Ethical Issues and Regulatory Principles in Clinical Trials (3 credits)
This course provides a step-wise approach to understanding clinical research and how today’s regulations impact tomorrow’s drugs. Early ethical guidelines such as the Nuremberg Code and the Declaration of Helsinki will be covered. The course also explores essential aspects of running clinical trials, including regulatory documents, regulatory inspections and adverse event and safety monitoring. Regulatory guidelines outside the U. S. will be covered.