Students will be prepared to work in a clinical research environment by learning clinical trial structure, the regulatory requirements that govern clinical trial execution and basic knowledge of collecting and analyzing clinical trial data. This comprehensive course discusses the operational elements of clinical trials, including structure, key regulatory requirements, data collection and analysis and successful trial conduct. Students learn how to conduct clinical trials, navigate the regulatory requirements for successful trial completion and the fundamentals associated with working with clinical trial data. Upon completion, students have a basic knowledge of clinical research concepts and structure enabling them to apply their skills in a clinical trial site or contract research organization environment.

Course Objectives

Define the terms associated with clinical research

Define the structure of a clinical trial

Define clinical trial roles and key players

Discuss basic regulations 21 CFR and ICH E6 and history of regulations

Discuss informed consent and financial disclosure requirements

Discuss Institutional Review Boards and essential regulatory documents

Define data management

Define clinical data and source data

Discuss the Case Report Form and how data is collected

Discuss and define data review: medical history, adverse event, concomitant medications and physical exam

Discuss and define the clinical database and edit check process

Write and answer data queries

Discuss basic statistics used in clinical research

Define and discuss scientific misconduct

Cite the requirements for successful subject recruitment

Discuss the roles and responsibilities of clinical site staff

Outline of Instruction

Introduction to Clinical Trials: Components of a Trial and Trial Roles (YouTube video lecture) Discuss syllabus, online environment and what is being studied: new drug (NME), device (nonmetabolized), Phase I-IV clinical site, PI, coordinator, lab, nurse, clinical trial office. Read: Chapter 1 of "Lessons from a Horse Named Jim," Nuremberg Code, Declaration of Helsinki, Belmont Report introductions. Find an article.

Good Clinical Practice (YouTube video lecture). FDA 21 CFR regulations ICH E6 guidelines. Read: FDA Regulations Overview - Hirschfield PowerPoint. Scan this website and the following sections of FDA Regulations related to clinical trials: 21 CFR 11 - Electronic Records, 21 CFR 50 - Protection of Human Subjects, 21 CFR 54 - Financial Disclosure, 21 CFR 56 - Institutional Review Boards, 21 CFR 312 - Investigation New Drug Application (IND), 21 CFR 314 - New Drug Application (NDA). All can be found at https://www.fda.gov/science-research/clinical-trials-and-human-subject-…. Read 21 CFR 312 - Investigational New Drug Application (IND) Subpart D - Responsibilities of Sponsors and Investigators. Scan ICH-GCP E6 Sections 2-5, pages 80-95 of the textbook. Read ICH-GCP E6, Sections 4 and 5, pages 83-93. Compare and contrast the FDA and ICH regulations.

Informed Consent Process (YouTube video lecture) Read: "Consent Issues in Human Research," pages 197-201, "Is Informed Consent Always Necessary?" pages 207-210, "Subject Interview Study," pages 213-216, "False Hopes and Best Data," pages 216-221, "Therapeutic Misconception in the Informed Consent Process," pages 221-223. Review ICF.

IRBs (YouTube video lecture). Read: "Monitoring Clinical Research," pages 425-429, 21 CFR 56 - Institutional Review Boards, Summary of Historical Documents

Responsibilities of Investigators (YouTube video lecture). Read: "Use of Human Tissues in Research," pages 311-312, "Drug-Free Research in Schizophrenia," pages 329-331, "Protecting Communities in Research," pages 340-341, "Protecting Communities in Biomedical Research," pages 342-343, "Ethical Imperialism?" pages 356-357, "Part 8: The Behavior of Clinical Investigators," pages 369-374, "Uderstanding Financial Conflicts of Interest," pages 375-377, "Finder's Fees for Research Subjects," pages 377-378, 21 CFR 54 - Financial Disclosure, "Finder's Fees - Good or Bad, Financial Disclosure - Necessary or Not.

The Clinical Site (YouTube video lecture) Read: Chapters 8, 10 and 11 of "Lessons from a Horse Named Jim. Exam 1.

Subject Recruitment (YouTube video lecture). Develop at recruitment plan and the research subject population. Read: Develop a Recruitment Plan, page 219, "Lessons from a Horse Named Jim." Discuss a recruitment strategy.

Data Management Roles and the Data Management Plan (YouTube video lecture). Discuss the history of the DMP. Discuss the topics covered the DMP - page 4. Discuss the supporting documents of the DMP and how they are used. Read: Chapter 1: The Data Management Plan and Appendix A: Data Management Plan Outline. Answer questions on the discussion board and discuss a component of the DMP.

CRF Design Entering and Reviewing Data (YouTube video lecture). Explain rules for creating CRFs. Discuss database design and the use of edit checks to clean data (Chapter 4). Review samples of CRF pages for flaws or potential errors. Read: Chapter 2: CRF Design Considerations. Discuss how data is reviewed from the CRF to the clinical database. Discuss edit checks and the edit specs document. Read: Chapter 4: Edit Checks and Chapter 6: Receiving Data on Paper. Two considerations for working with CRFs and avoiding transcription errors.

MH/AE/CM/PE Entering Data onto CRF Pages (YouTube video lecture). Lots of discrepancies live in these pages. Discuss the relationship between these three types of log pages. Read: Chapter 11: Collecting Adverse Event Data. Enter CRF data exercise. Why is collecting AEs important?

Cleaning Data Query Writing and Resolution (YouTube video lecture) Discuss: Data discrepancies, different types of queries. Read: Chapter 8: Cleaning Data. Write and resolve query examples, learn importance of query writing and resolution.

CDMS Coding Dictionaries (YouTube video lecture) Discuss: CDMS systems. Read: Chapter 19: Clinical Data Management Systems. Discuss: EDC Systems. Read: Chapter 20: EDC Systems. Discuss: Different coding dictionaries, such as MedDRA, WHODrug, etc. Read: Chapter 26: Coding Dictionaries and Systems.
In your words, what is the principal reason why the use of coding dictionaries is important in clinical trials?

DM Standards and Statistics (YouTube video lecture). Discuss CDISC and CDASH. Read: Krishnankutty, B., Bellary, S., Kumar, N. B., & Moodahadu, L. S. (2012). "Data management in clinical research: An overview." Indian Journal of Pharmacology, 44(2), 168-172. Introduction to Medical Statistics (https://www.youtube.com/watch?v=x8one-B_Y1w).
Go back to your article from Week 1 and determine which statistical assessments would be used to come up with the conclusions. Search online for statistics sites for help. Post your response on discussion board. Exam 2

Ethics of Trial Design (YouTube video lecture) Read: Placebo Controlled Trials, pages 137-140, The Ethics of Placebo-Controlled Trials, pages 140-144, The Changing Landscape of Human Experimentation, pages 146-151, Why Use Women and Minorities in Clinical Trials?, pages 171-175. Is the use of placebos ethical or not?

Special Populations (YouTube video lecture) Read: Part 6 Clinical Research with Special Populations, pages 225-228, Research Involving Persons with Mental Disorders, pages 229-233, Caring about Risks, pages 237-240, Convenient and Captive Populations, pages 258-262, Reverby, S. "Ethical Failures and History Lessons: The U.S. Public Health Service and Research Studies in Tuskegee and Guatamala," 18 pages. What would be your principal concern about working with special populations?

Scientific Misconduct (YouTube video lecture, "60 Minutes" segment about Dr. Anil Potti at Duke - https://www.cbsnews.com/news/deception-at-duke-fraud-in-cancer-care) Read: Gewin, V. (2012). Research: "Uncovering Misconduct," Nature, 485(7396), pages 137-139, "Pressure to Publish and Fraud in Science," pages 393-395, "Preventing Scientific Misconduct," pages 399-402. Based on what you learned from the articles and in class, what should you be alert to with regard to scientific misconduct and how should you best respond to it?

Database Lock and Study Closeout (YouTube video lecture) Discuss database lock, what happens after database lock and data safety management boards. Read Chapter 13 (Study Database Lock) and Chapter 14 (After Database Lock). Exam 3

Wrap-up with at least two industry guest speakers discussing data management and drug development initiatives. Student reflections on getting the most out of you career in clinical research.

Contact Hours

108

CEUs

1

Industry Standard, State or National Certification

Certification

Society of Clinical Research Associates (SOCRA)

Website

https://www.socra.org/

Certification Learning Outcomes/Requirements

The Certified Clinical Research Professional (CCRP) exam is available for individuals who meet the following criteria: Have two years of experience as a full-time clinical research professional (or have 3,500 hours part-time) during the last five years; hold a degree in Clinical Research from an associate, undergraduate or graduate degree program and have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a clinical research professional; hold an undergraduate or graduate certificate in Clinical Research with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) and hold an associate or bachelor's degree in a science, health science, pharmacy or related field and have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a clinical research professional.

CE or CU Articulation

No

Prerequisites

Background in science is preferred

Learning Supplies Needed

Please see class details for the required textbook and/or supplies

Clinical Site/Special Facilities

Computer with internet access

Requirements for Successful Completion

100% attendance
Full participation in each weeks' online assignments and discussion forum. Students will post weekly responses to discussion forum questions designed to assess their learning of the week's instructional content

Accreditation/Special Approval Requirements

N/A

Intended Audience

Individuals entering or progressing in a career in clinical research and students with education and training in the clinical trials field seeking professional certification offered by one or more of the skills-certifying organizations.

Specific Industry or Business Support Needs

Clinical research specialist, clinical research assistant, clinical research associate, clinical trials assistant, clinical trials specialist

Wake County Need for Industry Positions

The Triangle area is world headquarters for clinical research activities. In addition to the local pharmaceutical companies that call North Carolina home, the area includes large operations of the world's top contract research organizations, including IQVIA, PPD, Parexel, ICON and Syneos Health. These companies employ tens of thousands globally and thousands locally.

Industry or Job Titles Related to Training Outcomes for Employment

Related Courses

Course Contact Information

Health Science Non-Degree Programs https://cehealth.waketech.edu
919-747-0140
[email protected]