Course Syllabus

Course Description

The learner will be exposed to critical concepts in the design and conduct of clinical trials. 

 

Course Objectives

After completing this course, the learner will be able to:

1. Define good clinical practice.
2. State the strengths of the clinical trial study design.
3. Cite selected FDA rules and regulations governing the conduct of clinical trials.
4. Compare and contrast an adverse event with a serious adverse event.
5. Identify key portions of the informed consent process.
6. Outline the advantages of conducting a clinical trial in career development and integrate with advancing new treatment options in clinical practice.

 

Course Delivery: Online

 

Course Material: All course materials are included in the Canvas course

 

Course Textbook/Materials: Online

 

Course Organization

This course is organized into three learning modules and a bonus module, found on the course menu under the section “Modules.” Upon completion of the quizzes, you will receive a respective number of course credit hours.

 

Module 1: Pre-Study Concepts

• Principles of Good Clinical Practice
  
  • Understand the ethical and scientific guidelines surrounding the conduct of clinical trials.
  • Appreciate the Belmont Report framework of protection of human subjects of research.
  • Recognize the three basic principles of The Belmont Report, and their specific characteristics.
  • Delineate all 13 top-level principles of the Good Clinical Practice.
  • Learn about the extend of responsibilities of the principal investigator.
  • Increase familiarity with the obligatory completion of the CITI Program modules while meeting criteria for IRB requested GCP training.
• Phases of Clinical Trials
  
  • Identify the concepts of legal and clinical paths of drug development.
  • Differentiate all characteristic of phases in clinical trials and their challenges.
  • Learn about the structures of Randomized Clinical Trials (RCTs).
  • Delineate the advantages and disadvantages of randomized controlled trials.
  • Recognize “the power of placebo” in clinical investigations.
  • Assess the ClinicalTrials.gov criteria for registering a trial at the website.
• Clinical Trials Designs
  • Identify the points of interest when choosing a clinical study design.
  • Differentiate the strength of the experimental investigations.
  • Delineate an explanations of clinical trial designs.
  • Recognize the characteristics and differences between the study designs.
    
• The FDA approval process of Investigational New Drug (IND) and Investigational Device Exemption (IDE)
  • Understand the development and FDA approval process of a new drug or medical device for human use.
  • Identify the differences in what is required to obtain the FDA approval for a drug versus a medical device – concepts of Investigational New Drug (IND) or Investigational Device Exemption (IDE) Process.
  • Recognize the role of the Principal Investigator delineated in FDA 1572 form.
  • Learn what are the specific classifications of medical devices, based on the risks they pose to the patient and/or the user.
  • Describe the FDA regulations and conditions of IDE (Investigational Device Exemption) and HUD  (Humanitarian Use Device).
    
• Clinical Trials Sponsor and CRO
  • Define study sponsor, and study investigator in a clinical trial.
  • Understand the definition and purpose of a contract research organization (CRO).
  • Understand the purpose and phases of monitoring conducted by study sponsor and/or CRO in the conduct of a clinical trial.
• Confidential Disclosure Agreement (CDA), Clinical Trial Agreement (CTA), Budget Preparation & Negotiation
  • Define CDA and CTA as pertains to conducting a clinical trial at TTUHSC EP.
  • Start to build a working vocabulary of acronyms typically used in conducting pharmaceutically sponsored clinical trials that may not be familiar with MDs/clinicians who may chose to participate in these studies.
  • Gain a working knowledge of legal agreements and Principal Investigator (PI) duties in contractual type agreements involved in conducting a clinical trial.
  • Have greater working knowledge of what is required in preparing and negotiating a study budget when conducting a clinical trial.

 

Module 2: Study Related Documents

• How to get started with clinical research?
  
  • Identify the steps required for becoming a clinical trail investigators.
  • Differentiate the definition and terminology describing  particular agencies and organizations involved in clinical research.
  • Delineate an obligations of a Principal Investigator based on 1572 Form.
  • Recognize the characteristics of Good Documentation Practice.
• Sample Size in Clinical Studies
  • Compute the sample size for basic hypothesis testing of equality.
    • For a continuous outcome and a binary outcome between group.
  • Learn the sample size for estimation of disease burden or problem.
    • For a continuous outcome and a binary outcome between groups.
  • Learn the concept of statistical errors in sample size estimation.
    • Differences between Type I error and Type II error.
  • Understand the factors required for sample size estimation.
    • Know the minimum information needed for sample size estimation.
    • Factors that may increase the sample size and power analysis.
• TTUHSC EP and UMC IRB Approvals & Institutional obligatory training
  • Know the necessary training and certifications required by the institution before submitting a new clinical trial for TTUHSC EP IRB Approval.
  • Understand the process and necessity of coordinating with and obtaining approvals in order to conduct research and procedures at UMC & Children's Hospital.
    
• Clinical Trials: Benefits, Risks, Adverse Events, and Safety Monitoring 
  • Gain a working knowledge of benefits and potential risks of participating in clinical trials.
  • Learn the principles of subject safety, its protection and ethical guidelines.
  • Differentiate all characteristics of adverse events (AEs) and serious adverse events (SAEs).
  • Identify a Suspected Adverse Reaction and Unanticipated Problems.
  • Start to build a proper vocabulary describing classifications of AEs based on severity, expectedness, and potential relatedness to the study intervention.
  • Recognized the necessity of keeping accurate record of clinical trials and  Documentation Best Practice.
  • Understanding the concept of a Data and Safety Monitoring Board.

 

Module 3: Conduct of Clinical Trials

• Clinical Trials, Regulatory Compliance, Site Visits
  
  • Define the different types of monitoring visits.
  • Understand the objectives of each type of monitoring visit.
  • Know the expectations of the site by the monitor for these visits.
• Basic Informed Consent
  
  • (IRB Training - Optional)
• Recruitment & Retention of Study Subjects in Clinical Trials
  • Identify barriers and learn strategies for successful recruitment of subjects in clinical trials.
  • Familiarize with the most common barriers that affect retention of subjects in clinical trials and measures to overcome those barriers.
    
• Regulatory Documentation and Investigational Product Accountability
  • Define documentation required in the conduct of a clinical trial.
  • Enumerate documents required in the trial regulatory binder.
  • Understand the importance and how to document investigation product accountability.
    
• The Importance of the Research Team- Participant Relationship in the Success of Clinical Trials
  • Understand the importance of the research team’s relationship with participants in clinical research.
  • Delineate the elements of this relationship and considerations in various groups of participants.
  • Develop plans to improve this relationship to ensure a greater chance of completing a clinical trial successfully.
    

 

Module 4: Bonus Material

• Scholarly activity during residency - are clinical trials a good choice?
  
  • Understand the ACGME requirements for scholarly activity.
  • Describe barriers to scholarly activity for residents.
  • Explain facilitators to scholarly activity that residency programs can provide and implement.
  • Identify opportunities for clinical research participation.
  • Recognize the reasons if clinical trials are suitable choices for the residents/fellows.

 

Technical Requirements:

• Internet access - preferably high speed (for accessing Canvas)
• TTUHSC El Paso e-mail
• Microsoft Office (download from TTUHSC El Paso eRaider)
• WebEx (download from TTUHSC El Paso eRaider)
• Adobe Reader (download from Adobe.com)
• Flash Player (download from Adobe Flash Player)
• Audio and video playing capabilities (for watching/listening to course content)
• Web camera and microphone (for synchronous virtual meetings)
• PDF app (scanning of hand written documentation for graded assignments)

 

Technical Skill Requirements:

• Using a word processor
• Using email for communication, attaching documents in email
• Internet search engines and browsers
• Familiarity with Canvas

 

Assignments and Grading:

• For each module or session/topic in the course, you will complete a Self-Check Quiz. You must score 80% on each quiz. You will have three attempts for each quiz. 

 

Academic Dishonesty and Plagiarism

TTUHSC EP Institutional Student Handbook: Code of Professional and Academic Conduct 2020-2021

https://elpaso.ttuhsc.edu/studentservices/_documents/Institutional-Handbook-2020-2021.pdf ; pages 17-20.

“Academic dishonesty” includes, but is not limited to, cheating, plagiarism, collusion, falsifying academic records, misrepresenting facts, and any act designed to give unfair academic advantage to the learner (such as, but not limited to, submission of essentially the same assignment for two courses without the prior permission of the instructor) or the attempt to commit such an act. If a learner is involved in any form of academic misconduct and is proven that the action took place, the instructor may initiate a disciplinary action.

 

Special Needs (TTUHSC EP HSCEP OP: 77.14, Students with Disabilities (https://elpaso.ttuhsc.edu/opp/_documents/77/op7714.pdf ) also HSCEP OP: Online and Distance Education https://elpaso.ttuhsc.edu/opp/_documents/59/op5902.pdf)

 Any student who, because of a disability, may require special arrangements in order to meet the course requirements should contact the instructor as soon as possible to make any necessary arrangements. Students should present appropriate verification from Student Disability Services during the instructor’s office hours. TTUHSC EP Office of Academic and Disability Support Services, Hector Noriega, MA, Assistant Director for Academic and Disability Support Services, hector.noriega@ttuhsc.edu, 915-215-6018.

 

Religious Observances (TTUHSC EP HSCEP OP: 77.12, Religious Holy Day Observance and Need for Student Absence (https://elpaso.ttuhsc.edu/opp/_documents/77/op7712.pdf)

 "Religious holy day" means a holy day observed by a religion whose places of worship are exempt from property taxation under Texas Tax Code §11.20.A learner who intends to observe a religious holy day should make that intention known in writing to the instructor prior to the absence. A learner who is absent from classes for the observance of a religious holy day shall be allowed to take an examination or complete an assignment scheduled for that day within a reasonable time after the absence.

 

Instructor’s Expectations

You will be expected to log into the Canvas course regularly to be aware of possible announcements/reminders and to pace your progress in the course. Course participants are expected to maintain an online environment conducive to learning, which includes “netiquette” (Internet etiquette). The following site includes basic rules for Online Discussion Netiquette. Ensure that your e-mail messages, discussion board postings, and other electronic communications are thoughtful. Diverse opinions we welcome in this course. The following are prohibited:

• making offensive remarks in e-mail or the discussion board
• using inappropriate language or discussing inappropriate topics online
• spamming
• hacking,
• using TTUHSC El Paso or Canvas e-mail or discussion board for commercial purposes
• using all caps (considered shouting in online communications)
• cyber-bullying or online harassment of any type

 

Disclosure

This syllabus is intended to give the participant guidance in what is covered during the IFDP 20 and will be followed as closely as possible. However, the OFD reserves the right to modify, supplement and make changes as the program needs arise or change.

 

Communication Plan

• You may expect a reply from the instructor within two business days.
• Please use the Canvas course message tool or the TTUHSC El Paso email system for all communication.

 

Technical Difficulties

• Online Help
• Computer problems
• Server problems
• Lost/corrupt/disappeared files

 

Technical Support

• TTUHSC EP Canvas/IT support

https://elpaso.ttuhsc.edu/som/curriculum/itresources.aspx

• Contact Help Desk

https://elpaso.ttuhsc.edu/elpaso/it/institutional-technology-services/computer-support-services/contact.aspx

• Hours and Contact Info

https://elpaso.ttuhsc.edu/elpaso/it/institutional-technology-services/computer-support-services/contact.aspx

 

Telephone

Call 915-215-4111

Option 1: Helpdesk
Option 2: Classroom Technology
Option 3: EMR

 

E-mail

Submit your question to elp.helpdesk@ttuhsc.edu
Provide as much detail as possible.

 

Walk-in

CSB Basement, Rm B-08A
7:00 AM - 6:00 PM

MEB 2nd floor, Rm 2160
8:00 AM - 5:00 PM

 

Clinical Trials Course Contact Information

 

Support	Name/Family Name	E-mail
eLearning Innovation Team (Lead Analysts)	Raul Alvarez Lopez, BS Marco A. Rodriguez, MS, MEd	raul.alvarez@ttuhsc.edu  marcoa.rodgriguez@ttuhsc.edu
Administrative Support	Consuelo Rosales, BS	consuelo.rosales@ttuhsc.edu