Clinical Research Undergraduate Certificate

The Undergraduate Certificate in Clinical Research trains health professionals to contribute to the design, conduct, and analysis of clinical trials. As the link between the biomedical industry and the physician, a clinical research professional assists in the testing and evaluation of new drugs, devices, and procedures.

Students who complete the Certificate in Clinical Research will be able to demonstrate:

  • Knowledge of drug development (pre-clinical and clinical phases) and how federal regulations, especially 21 CFR (code of federal regulations), impact both phases.
  • Competence in writing a clinical trial protocol, informed consent form, and IND (investigational new drug application); competence in designing a clinical study.
  • Proficiency in working with a team toward a common goal, and utilizing best practices within an ethical and safe environment

Please contact the program director for additional information.

Students in the Clinical Research Undergraduate Certificate Program must complete a minimum of 16 credits. Admittance to a certificate program requires submission of a résumé and application, as well as an interview with the program director, to help determine the student’s goals and design the appropriate curriculum. Below are examples of courses from which to choose:

Understanding medical terminology is fundamental for anyone working in the sciences. It is the language of the technician or researcher involved in biotechnology, biomedical investigations, or clinical research. Students learn the analysis and construction of medical words within a context of scientific concepts. After the basics, students learn the anatomy and diseases of the following systems: male and female reproductive, cardiovascular, respiratory, and blood. Technology fee applies to online section only.  [ 2 cr. ]

Fall 2017
Section Type Instructor Location Days Times
OL IND Coleman ARR
Spring 2018
Section Type Instructor Location Days Times
OL IND Staff ARR

Prereq: GMS BT 104 (Med Term 1) or consent of program director. Continue building your medical vocabulary as you learn the anatomy and diseases of the following systems: digestive, urinary, lymphatic/immune and endocrine. Technology fee applies to online section only.  [ 2 cr. ]

Section Type Instructor Location Days Times
OL IND Coleman ARR

Prereq: GMS BT 560 GCP or equivalent or consent of program director. This course introduces students to the structure, content, and regulatory requirements of documents created for the clinical research industry. Students learn about FDA regulations and ICH guidelines for drugs and biologics, the AMA Manual of Style, and other common industry standards. Students learn to apply these industry standards to compose clinical research documents such as a clinical study protocol, informed consent form, and clinical study results.  [ 4 cr. ]

Section Type Instructor Location Days Times
A1 IND Thayer INS 109C M 6:00 pm – 8:45 pm

This course provides students with an introductory overview of the world of medical devices, from bandages to defibrillators. Students explore what the applicable regulations are, starting with the FDA, and how companies use these regulations to guide the design, development, and marketing of their products. Most classes contain an interesting mix of rules, realities, and renegades, that includes a unique component called, "At the Drugstore," where students focus an educated eye on commonly found items on the shelf. In addition, students learn about jobs and career opportunities within the medical device industry and how to gain entry into the field.  [ 4 cr. ]

Clinical research auditing ensures that the rights, safety, and well being of the study subject have been protected and the clinical study data are credible. Auditing clinical trial activities provides the strict oversight of performance with the ultimate goal of having a successful submission and identifying opportunities for improvement. In this practical course, students learn how to prepare and conduct audits, write audit observations, create an audit report and review audit report responses. In addition, students learn how to manage audits by an outside agency. Good Clinical Practice (GCP) guidelines and regulatory requirements are reviewed along with exploring the concept of a quality system and the writing of audit program Standard Operating Procedure (SOP). Developing an audit plan is emphasized. Group discussions and role- playing are used to develop practical audit techniques. This class prepares a student for an introductory auditing position within clinical research.  [ 4 cr. ]

Prereq: One semester of biology, two semesters of chemistry and BT 405 (Biochem). This course covers laboratory technologies utilized in the pre-clinical drug development phase with emphasis on the issues and challenges of molecular targeted therapeutics, a new paradigm in drug discovery. In addition, DNA, RNA and protein-based therapeutics, and gene and stem cell therapies are discussed. Students learn about translational technologies used to identify and validate drug targets, as well as lead optimization and selection of drug candidates. A hands-on laboratory component reinforces drug discovery concepts.  [ 4 cr. ]

Prereq: One semester of biology, two semesters of chemistry, and BT 405 (Biochem). BT 575 (Design & Conduct of Clin Trials) recommended. This course explores how drugs developed at the bench transition to clinical testing and subsequently to the market. The translational approach in drug development is discussed as well as current translational technologies. Topics include the molecular and pathophysiological basis of select diseases; drug design; pre-clinical testing; clinical evaluation of drugs; regulatory requirements for drug approval; and the frontiers of translational research. Lectures are combined with discussions and presentations.  [ 4 cr. ]

Section Type Instructor Location Days Times
A1 IND Fridkis-Hare INS 214 S 8:30 am – 11:50 am

Prereq: BT 560 (GCP), BT 575 (Design & Conduct of Clin Trials) or consent of program director. This course integrates a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research. Through lectures, case studies and discussions, students examine the concepts and applied techniques for cost estimation, budgeting, allocation of resources, risk management and quality assurance for clinical research projects. Project management principles and methodologies are discussed with a special focus on planning, controlling, and coordinating individual and group efforts.  [ 4 cr. ]

Prereq: one semester biology and 2 semesters of chemistry, BT405 recommended. This course introduces the basic principles of pharmacology and several major classes of therapeutic agents, with attention to their mechanisms of action. Issues of current and future directions in pharmacology are addressed including the source of information about pharmacologic agents, the ethics of human experimentation, the drug development process, and new biotechnological approaches to drug design.  [ 4 cr. ]

Clinical research is conducted to meet the needs of the intended patient population with an investigational medical intervention. But a favorable medical outcome is not the only criterion that is used to judge whether a product can be marketed. Clinical research needs to meet the rigorous standards of the regulators, the ethicists, and the auditors. This course reviews the laws that are in place that are designed to guide the complexities of clinical research. We will use case studies to illustrate what can really happen when clinical studies are conducted -- you may be surprised with what you find. Using group activities and exercises, we will explore the options and approaches used to manage these clinical research issues. 4 cr.   [ 4 cr. ]

Introduces students to the technology, process, and responsibilities of clinical data management. Students examine study setup, case report form (CRF) design, and the data life cycle, including data collection, data validation, coding of adverse events using standard dictionaries (such as ICD-9 or MedDRA), data review, and database lock. Data Management SOP's are discussed within this context. An industry-leading clinical data management system (CDMS) is utilized. Students also explore how new technologies, such as electronic data capture (EDC), affect these processes.  [ 4 cr. ]

This course introduces the international standards for ethical conduct of research and maintaining the highest level of scientific quality when conducting clinical trials. Topics include the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials; the phases of clinical trials leading up to FDA approval of a new drug or device; and how to get a trial up and running including the selection of qualified investigators, obtaining approval to conduct the study from an ethics committee, and completing the regulatory documentation that is required for getting a site ready to enroll patients. The course also covers ensuring data integrity, handling ethical dilemmas, and reporting of serious adverse events. Case studies, review of current media, and exercises will be used to practice the application of information provided in class and to demonstrate GCP compliance from an industry perspective. Group discussions, individual and group projects, and guest speakers help students learn the practical skills used in the field.  [ 4 cr. ]

Section Type Instructor Location Days Times
A1 IND Beaudette-Zl EVN 201 T 5:30 pm – 8:50 pm

Prereq: knowledge of biostatistics. This course covers basic principles and current methodologies used in the design and responsible conduct of clinical trials. Topics include statistical design of clinical trials, sample selection, data collection and management, patient recruitment strategies, adverse event reporting, and compliance monitoring. Practical exercises include writing clinical research protocols and informed consent forms, and designing case report forms.   [ 4 cr. ]


View all Biomedical Laboratory & Clinical Sciences undergraduate courses.