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.

Program Requirements

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:

GMS BT 104 Medical Terminology 1
Fall ‘14

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.  [ 2 cr. ]

Section Type Instructor Location Days Times
A1 IND Coleman L 109C T 5:30 pm – 8:30 pm
B1 IND Thoidis ARR S 9:00 am – 12:00 pm
GMS BT 106 Medical Terminology 2

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.  [ 2 cr. ]

GMS BT 160 Biotechnology 1

This course introduces students to the basic sciences of biotechnology (cell biology, immunology, DNA/molecular biology) and describes DNA technologies used in gene therapy and microarray technology and in the production of recombinant protein drugs, antibodies, vaccines, and transgenic animals/plants. The challenges of bringing protein drugs from R&D through large scale manufacturing and the FDA approval process are also discussed. First half of spring semester.  [ 2 cr. ]

GMS BT 170 Biotechnology 2

Prereq: BT 160. Recent innovations in the fields of molecular biology, immunology and cell biology have provided new insights into the pathogenesis of cancer, infectious diseases, and other intractable diseases. The biotech industry has contributed immensely to this progress and has furthermore accelerated the development of cutting-edge technologies that promise to deliver more effective drugs, vaccines and diagnostics. Biotechnology 2 explores some of the ways in which biotechnology has impacted medicine. Students participate in this exploration through readings of recent scientific articles, class discussions and library/internet research. Second half of spring semester.  [ 2 cr. ]

GMS BT 210 Technical Writing in Clinical Research

This course introduces students to the structure, content, and regulatory requirements of documents created for the clinical research industry. Students review the FDA regulations and ICH guidances for drug, device and biologic documents, AMA Manual of Style Guidelines, and common industry standards. Students also learn to compose study abstracts, clinical protocols, informed consent forms, and clinical study reports.  [ 4 cr. ]

GMS BT 360 Auditing in Clinical Research

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. ]

GMS BT 460 Drug Discovery
Fall ‘14

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. ]

Section Type Instructor Location Days Times
A1 IND Malikova L 206 T 5:30 pm – 8:30 pm
GMS BT 462 Drug Development

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. ]

GMS BT 470 Technologies in Clinical Research

Prereq: 1-2 years clinical research experience or one of the following-- BT 540 (Reg & Compl, BT 560 (GCP), BT 575 (Design & Conduct of Clin Trials). This course explores the multiple technologies that govern key aspects of clinical trial management and regulatory filings. Students learn how to identify the various technologies that are used in the conduct of clinical trials, the regulations that govern their use, and the issues that companies face in deploying the various tools. Students also examine a sample company with a clinical portfolio and identify the timing, importance, and integration requirements of the various technologies with emphasis on strengths and weaknesses associated with the conduct of the trial. The course also includes an introduction to the use of social media in clinical trials.  [ 4 cr. ]

GMS BT 530 Introductory Pharmacology

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. ]

GMS BT 540 Regulatory and Compliance Issues

This course explains the regulatory requirements for health care products: drugs, biologics, diagnostics, and devices. The focus is on U.S. FDA regulations and their impact on product development and marketing with international requirements. Recommended for students in clinical research concentration.   [ 4 cr. ]

GMS BT 550 Clinical Data Management
Fall ‘14

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. ]

Section Type Instructor Location Days Times
A1 IND Tobia L 212 M 5:30 pm – 8:30 pm
GMS BT 560 Good Clinical Practices (GCP) in Clinical Research
Fall ‘14

This course introduces the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed for the clinical trial professional on procedures for ensuring GCP compliance from an industry perspective. Topics include identifying and selecting qualified investigators, obtaining ethical approval to enroll patients, and initiating sites successfully. The course also covers issues related to collecting required regulatory documentation, verifying high quality data, maintaining study materials accountability, and reporting serious adverse events. Group discussions and guest speakers help students learn the practical skills used in the field.  [ 4 cr. ]

Section Type Instructor Location Days Times
A1 IND Tobia R 115 W 5:30 pm – 8:30 pm
GMS BT 575 Design and Conduct of Clinical Trials
Fall ‘14

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. ]

Section Type Instructor Location Days Times
A1 IND Malikova L 203 R 5:30 pm – 8:30 pm
GMS BT 580 Legal and Ethical Issues in Clinical Research

This course examines the development and implementation of regulatory as well as ethical issues involved with conducting clinical trials. Topics include: use of human subjects, privacy and confidentiality, conflicts of interest, use of stem cells in research, federal laws affecting laboratories, and genetic testing of gene and therapy trials. Students also participate in discussions on landmark legal cases affecting laboratory scientists.  [ 2 cr. ]


View all Biomedical Laboratory & Clinical Sciences undergraduate courses.