Course Descriptions

CRC 101 - Foundations of Clinical Research

1. Explain the evolution of the requirements for informed consent from research participants.
2. Identify the principles and content of the key documents that ensure the protection of human participants in clinical research.
3. Describe the ethical issues and safeguards concerning vulnerable populations.
4. Explain the phases and purposes of clinical studies as part of the drug development process.
5. Identify and apply the professional guidelines and code of ethics that apply to the conduct of clinical research.

1. Identify necessary skills and attributes of the clinical research coordinator (CRC).
2. Prepare an organizational chart depicting a typical research team.
3. Identify medical, pharmaceutical, and research related terminology and acronyms

1. Evolution and History of Clinical Research and the Protection of Human Subjects in Clinical Research 
   1. Tuskegee Syphilis Study
   2. World War II human experiments
   3. Nuremberg Code
   4. Human Radiation Experiments
   5. 1960’s Thalidomide Tragedy
   6. Kefauver-Harris Amendment
   7. Milgram Study
   8. Declaration of Helsinki
   9. Beecher article, New England Journal of Medicine
   10. Belmont Report
   11. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical/Behavioral Research
   12. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
   13. Sub-committee on Health and Science               
2. Evolution and History of the Clinical Research Process
   1. U.S. laws governing the development and marketing of drugs and devices
   2. Bioresearch Monitoring Program
   3. Federal regulations and International Community for Harmonization (ICH) guidelines
3. Overall Process of Clinical Research Development of Drugs, Devices and Biologics
   1. Government agencies and international initiatives involved in clinical research
   2. New drug and biologic development and marketing approval process
   3. Medical device development and marketing approval process
4. Informed Consent        
   1. Elements of consent: Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) and International Community for Harmonization (ICH)
   2. Comprehension
   3. Autonomy vs. coercion
   4. Documentation
   5. Exceptions to consent
   6. Health Insurance Portability and Accountability Act (HIPAA) compliance
5. Components of Clinical Trial Designs for Phases I through IV
6. Selected Common Medical and Pharmacologic Terms Used in Clinical Research
   1. Identification
   2. Definition
   3. Abbreviation
   4. Appropriate utilization of common medical terms and abbreviations
7. Members of a Clinical Research Study Team: Roles, Responsibilities and Interdependencies
   1. Study coordinator
   2. Clinical pharmacist
   3. Statistician
   4. Project leader/manager
   5. Auditor
   6. Clinical investigator
   7. Clinical research associate/monitor
   8. Data manager
   9. Medical officer
   10. Medical writer
   11. Regulatory affairs personnel
   12. Basic Scientist (Translational research)
   13. Epidemiologist
   14. Contracts and Legal personnel
   15. Quality Control and Quality Assurance officer
   16. Bioinformatics Programmer
8. Skills and Performance Expectations of the Clinical Research Coordinator      
   1. Professional demeanor
   2. Application of knowledge and experience
   3. Team player
   4. Communication skills
   5. Attention to detail
   6. Professional dress
9. Organizations Involved in the Clinical Research Process
   1. Pharmaceutical, biotech and medical device companies
   2. Clinical research organizations
   3. Site management organizations
   4. Institutional review boards
   5. Investigative sites
   6. Academic research organizations
   7. Research laboratories
   8. Research funding agencies (e.g., private foundations, governmental agencies and non-governmental agencies)
   9. U.S. FDA and other regulatory agencies
   10. Data Safety and Monitoring Board
   11. National Institutes of Health
   12. National Cancer Institute
10. Basic Clinical Trial Ethical Considerations in the Conduction of a Clinical Trial
    1. Pre-trial Ethical considerations
       1. Study design
       2. Selecting a comparison treatment or intervention
       3. Randomized trials
       4. Inclusion/exclusion criteria
       5. Working with vulnerable populations
    2. Ethical considerations during trial
       1. Recruitment
       2. Barriers to recruitment
       3. Confidentiality and privacy
       4. Compensation for research-induced injury
       5. Monitoring the study
       6. Issues relating to confidentiality and disclosure
    3. Post-Trial ethical considerations
       1. Authorship
       2. Obligation to inform
11. Professional Research Associations and Their Respective Roles 
    1. Society of Clinical Research Associates (SoCRA)
    2. Association of Clinical Research Professionals (ACRP)
    3. Drug Information Association (DIA)
    4. Regulatory Affairs Professional Society (RAPS)
    5. Society of Clinical Data Management (SCDM)

CRC 110 - Clinical Research Common Terminology

1. Describe the component parts of medical terms using basic prefix, suffix, and combining forms to build medical terms
2. Relate the terms that describe the body to the names, locations, and functions of the major organs of the body systems
3. Define abbreviations and terms used in documenting medical records using the SOAP Method
4. Define an Adverse Event using the CTCAE guidance

1. Basic Word Structure
   1. Analyze medical words by using the tools of word analysis by dividing them into component parts (prefixes, combining forms, and suffixes)
   2. Medical terms related to the structure and function of the human body (in the context of how the body works in health and disease)
   3. Spelling and pronunciation of medical terminology
   4. Medical words divided into their component parts
   5. Meaning of basic combining forms of the medical language
2.  Prefixes and Suffixes
   1. Define prefixes and suffixes
   2. Analyze words using prefixes and suffixes with combining forms to build and understand medical terminology
3. Use of the SOAP Method to build, define, pronounce, and spell medical conditions of the
   1. Integumentary System
   2. Musculoskeletal System
   3. Nervous System
   4. Sensory System
   5. Endocrine System
   6. Lymphatic and Hematologic Systems
   7. Cardiovascular System
   8. Respiratory System
   9. Gastrointestinal System
4. Applying Medical Terminology
   1. Medical History Collection
   2. Patient Education
   3. Presentations
   4. Adverse Event Collection
      1. Common Terminology Criteria for Adverse Event (CTCAE)
      2. Activities of Daily Life Instrument (ADL)
      3. System Organ Classification (SOC)
      4. Medical Dictionary for Regulatory Activities (MedDRA)
   5. Clinical Research Reporting
   6. Quality Assurance and Quality Control

CRC 201 - Clinical Research Regulatory Compliance

1. Discuss the historical events that precipitated the development of governmental regulatory processes for investigational products
2. Identify Good Clinical Practice (GCP) Guidelines
3. Summarize the principle methods of balancing risk and benefit through selection of study participants
4. Differentiate between a sponsor audit, an IRB audit, and an FDA inspection
5. Identify the key steps in the drug development/device approval process

1. The Role, Function, and Organization of the Food and Drug Administration (FDA)
   1. Brief history of the FDA
   2. 3-part mission of the FDA
   3. Definitions for major product characteristics
   4. FD&C Act, Code of Federal Regulations, FDA and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidance
   5. How to contact and interact with the agency
   6. Agency role in oversight of clinical studies
2. Compliance with Good Clinical Practices
   1. Overview of ICH Guidelines E.6
   2. Monitoring of clinical research-sponsor obligations and expectations
   3. Routine GCP audits associated with sponsor marketing applications
   4. Handling, understanding, and responding to FDA Form 483
   5. FDA GCP “for cause” audits
   6. FDA’s fraud policy
   7. Regulatory sanctions for noncompliance
3. Regulatory Documentation Requirements for Clinical Studies
   1. Completion of Form FDA 1572 (Investigator’s commitment)
   2. Required Investigator and sub investigator information
   3. Institutional Review Board Approvals as required
   4. Types of studies that require Financial Disclosures
   5. Informed Consent and Re-consent process
   6. Preparation and maintenance of Site Regulatory Binders
   7. Study medication storage and accountability
   8. Archiving of study-related documentation
   9.     Documents required before drug can be shipped
4. Safety Reporting
   1. Routine adverse event reporting
   2. When is an AE a SAE?
   3. SAE reporting obligations to the sponsor, IRB, and other investigators
   4. How to submit 7- and 15-day IND safety reports for SAEs
   5. How to prepare follow-up reports and conduct ongoing safety review
   6. Termination of clinical studies for safety reasons
   7. Use of the Med Watch and Council for the International Organization of Medical Science (CIOMS) safety reporting forms
   8. Drug Safety Monitoring boards
   9. New FDA safety initiatives

CRC 202 - Investigational Product Development and Regulation

1. Explain the Investigational Products Development Process
2. Describe the roles and responsibilities of those involved in the Investigational Products Development Process
3. Explain the purpose of pharmacovigilance
4. Summarize the methods of safety monitoring
5. Describe the management and training approaches to mitigate risk

1. Analyze case studies and current events to appreciate ongoing issues & concerns
2. Apply applicable laws, regulations, and guidelines to recommend possible solutions

1. Introduction to the Drug Development Process
   1. Key elements of a drug development project
   2. Role of various personnel involved
   3. Basics of project management skills and their use in clinical projects
   4. Current status of biomedical industry and future trends
   5. Government and non-government agencies involved in regulating medical products and life cycle
   6. Steps from Research & Development to post-marketing
2. Introduction to Food and Drug Administration (FDA) Regulatory Process
   1. US FDA vs. international regulators
   2. Overview of FDA
      1. Organization and responsibilities
      2. Laws, regulations, guidance
   3. FDA applications (IND, IDE, NDA, BLA, etc.)
   4. Fees for FDA review
   5. FDA enforcement processes
      1. Audits
      2. Documents  
      3. Warning letters
      4. Penalties
      5. Interaction with FDA
3. Clinical Trial Applications
   1. Clinical trial approval applications
      1. Investigational New Drug (IND)
      2. Investigational Device Exemption (IDE)
   2. Key components of clinical trial approval applications
   3. Basic principles of Good Lab Practices (GLP)
   4. Basic principles of Good Manufacturing Practices (GMP)
   5. Logistics of an FDA application review process and its role in the clinical project planning
4. Good Clinical Practices (GCP)
   1. US and international standards for conduct of clinical trials
   2. Roles and responsibilities of various personnel involved in clinical trials (physicians, nurses, pharmacists, ethicists, advertisers, and investors)
   3. FDA Audits
   4. Bioresearch Monitoring Board
5. Adverse Event Management in Clinical Trials
   1. Best practices for safety monitoring and management of adverse events in a clinical trial project.
   2. Safety reporting requirements
   3. Time-lines for reporting to regulators

CRC 230 - Clinical Research Design

1. Explain the basic and complex types of research methods and how they relate to clinical trial design.
2. Apply ethical principles of research to clinical trial protocols and data collection procedures.
3. Describe how statistics and informatics relate to trial objectives, data analysis, and interpretation.
4. Discuss the evaluation and interpretation of clinical trials results.
5. Explore elements to present research findings.

1. Identify Study Question, Objectives, and Procedures
2. Select an Optimal Study Approach to answer the Study Question.
3. Design the trial and create a data collection plan.
4. Discuss elements of Data Analysis
5. Communicate research findings.

1. Scientific Approach Applied to Development of Research Protocol
   1. Overall process of clinical research development
   2. General Principles of investigational product regulation
2. Development of appropriate research hypothesis specific to each phase of protocol development
   1. Selecting a Research Question
   2. Reviewing the Literature
   3. Defining Study-Specific Aims
      1. Background information including a synopsis of the properties of the investigational product
      2. Study objectives and purpose
      3. Study goals and endpoints
      4. Selection of subject and precedent for subject withdrawal
3. Selecting a Study Approach
   1. Overview of research designs
   2. Case Studies
   3. Cross-Sectional Studies
   4. Case-Control Studies
   5. Cohort Studies
   6. Experimental Studies
   7. Qualitative Studies
   8. Correlational Studies
   9. Synthesis Research
4. Designing the Study and Data Collection
   1. Research Protocols
   2. Ethical Considerations
   3. Ethical Review and Approval
   4. Population Sampling, Sample Size, and Power
   5. Collecting Quantitative and Qualitative Data
   6. Developing Questionnaires and Assessments
5. Analyzing Data
   1. Data Management
   2. Descriptive and Comparative Statistics
   3. Regression Analysis
   4. Qualitative Analysis
   5. Additional Analysis Tools
6. Reporting the Findings
   1. Posters and Presentations
   2. Article Structure
   3. Citing

CRC 240 - Pharmacology for Clinical Trials

1. Summarize the drug development process from a pharmaceutical perspective.
2. Define pharmacology terminology.
3. Explain the principles and process of clinical pharmacokinetics.
4. Discuss factors that influence drug absorption, drug distribution, drug metabolism, and drug excretion.
5. Independently research drug-related information from reference sources.
6. Categorize drugs based on indication and mechanism of action.
7. Identify the effects of pharmacogenetics and their relationship to drug
   development.
8. Discuss common medical diagnoses and the related common
   drug treatments (brand and generic), including the drug actions and side effects.
9. Evaluate the most prevalent and serious adverse effects associated with common prescription and over-the-counter drugs.

1. Pharmacokinetics
   1. Half-life
   2. Drug Vehicle
   3. Therapeutic range
   4. Steady-state
   5. Bioavailability
   6. Routes of administration
   7. Absorption, distribution, metabolism and excretion (ADME)
2. Pharmacodynamics
   1. Effects of drug
   2. Mechanism of drug action
   3. Dose and concentration response
   4. Selectivity of drug action
3. General Concepts and Terminology
   1. Explanation of drug metabolism
   2. Drug interactions
   3. Biotransformation pathways
   4. Pharmacogenetics
   5. Prodrugs
4. Adverse Reactions
   1. Reactions
      1. Adverse reactions
      2. Serious adverse reactions
   2. Allergic reactions to report
   3. How to report
5. Drug Development
   1. Target identification
   2. Screening for lead compounds
   3. Animal testing
   4. Investigational new drug (IND) application
   5. Phase - dose finding
   6. Phase II - assessment of response rate in different populations or pathologies
   7. Phase III - assessment of response compared to standard of care)
   8. NDA FDA review
   9. Phase IV - after market testing
6. Common Medical Diagnoses and Drug Treatments
   1. Diabetes
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   2. Hypertension        
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   3. Cholesterol and triglycerides
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   4. Heart disease
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   5. Pulmonary disease
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   6. Osteoporosis
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   7. Gastrointestinal diseases
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   8. Depression/anxiety/insomnia
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
7. Drugs Used for Multiple Diagnoses/Indications 
   1. Steroids    
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   2. NSAIDS
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   3. Pain relievers
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
8. Over-the-Counter Drugs (OTC’s) and Supplements
   1. OTC’s
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
   2. Supplements
      1. Importance of documentation
      2. Interactions with prescription medications

CRC 245 - Data Management and Informatics

3 Credits, 3 Contact Hours
3 Lecture periods 0 lab periods

Essential knowledge of the organization and management of research data, and effective presentation of data in reports. Topics include how data are acquired and managed during a clinical trial, including source data, data entry, queries, database structures, data management systems, quality control, and quality assurance. Also includes data confidentially and security; and preparation of case report forms.

Recommendation: Completion of CRC 101   and MAT 106   or other college-level statistics course approved by the program director. If any recommended course is taken, see a financial aid or Veteran’s Affairs advisor to determine funding eligibility as appropriate.
Information: Upon completion, students will be able to organize, enter, and review clinical research data within an electronic data capture system. Textbooks and materials are not required for this course.
Course Learning Outcomes

1. Examine the role of statistics and informatics in clinical trials.
2. Explain the origin, flow, and management of data through a clinical trial.
3. Explore best practices and resources used for data collection, capture, management, and analysis.
4. Explore communication methods to stakeholders about study findings and reporting.
5. Develop processes for data quality assurance.
6. Evaluate data collection forms for completeness and accuracy.

1. Clinical data management process for clinical trial
2. Elements of a data management plan
3. Appropriate database design and its development

II. Various Data Collection and Data Capture Procedures

1. Various schemes and methods of data collection
2. Methods of randomization and documentation procedures
3. Various methods for data capture

III. Designing Data Collection Forms

1. Relevant data and outcome parameters
2. Methods to capture baseline and follow-up data
3. Appropriate closed-end questions to capture unambiguous data

IV. Reviewing Data Collection Forms

1. Completeness and accuracy
2. Advantages and disadvantages of single entry versus double entry
3. Data validation methods and the role of database definition in validation
4. Computerized checks, data queries, and appropriate methods for data correction
5. Common errors and omissions on case report forms
6. Function of quality assurance related to clinical data management

V. Collecting Pertinent Data to Assist in Specified Research Publication

1. Basic principles of coding dictionaries and their function
2. Appropriate method for handling expedited safety reporting for investigational drugs and devices
3. Appropriate method for handling safety reporting for marketed drugs and devices
4. Content of periodic update reports to the IRB
5. Structure and content of an integrated study report filed with a regulatory agency in support of a request for marketing approval
6. Methods for database changes, and appropriate timing for changes once a clinical trial is started

VI. Reviewing Research Data for Subject Safety

1. Patient case report forms, data listings, and instances of deviation from the approved study protocol
2. Patient case report forms, data listings, and subjects who received concomitant medication, or experienced concurrent illness during the study, or had secondary diagnoses
3. Patient case report forms, data listings, and subjects who died or experienced serious adverse events, or withdrawals from the study due to adverse events
4. Patient case report forms, data listings, and subjects with significant (as defined in the protocol and analysis plan) deviations from a defined normal limit in laboratory parameters

VII. Generating a Final Study Report and Publications

1. Regulatory requirements for a final study report
2. Required elements of a final study report
3. Generate draft sample final study report
4. Structure and content of a paper prepared for peer-reviewed journal publication of clinical research data

CRC 250IN - Clinical Research Site Coordination and Trial Implementation

1. Describe the roles and responsibilities of the clinical investigation team as defined by Good Clinical Practice Guidelines
2. Develop the operational efficiencies necessary to conduct a clinical trial.
3. Develop a recruitment plan to recruit and retain study subjects
4. Describe the methods used to identify and manage safety issues.
5. Develop a management plan for a research site project
6. Demonstrate maintenance of records for investigational products and research specimens.

1. Study Start-Up Review
   1. Site and Sponsor Feasibility Assessment Procedures
   2. Start Up-Related Meetings and Agreements
      1. Pre-Study Qualification Visit
      2. Site Initiation Visit
      3. Investigator Meeting
      4. Confidentiality Agreements
      5. Clinical Trial Agreements
   3. Planning and Preparation of Research Budgets and Negotiations
      1. Process involved in the development of a research study budget
      2. Routine calculations associated with the costs of a clinical research trial
      3. Assisting in the calculations of an overall research project budget, including personnel costs, overhead, and profit margin
2. Coordinating a Clinical Research Project
   1. Development of an overall plan for a clinical research project
      1. Elements of Project Management
         1. Developing a detailed plan (including time lines) for each phase of the clinical research project
         2. Effective communication between project team members and clinical trial management
   2. Operational Site Management
      1. Drafting Standard Operating Procedures
      2. Site and Staff Training Procedures and Documentation
      3. Study-related Equipment Maintenance
      4. Implementing Corrective and Preventive Action Plans
   3. Mitigating problems that can commonly occur between clinical research sites and Sponsors/Contract Research Organizations
   4. Recruitment, Enrollment and Retention of Study Subjects
      1. Subject recruitment plan 
      2. Required IRB Approvals of Advertisement Materials
      3. Informed Consent Procedures
   5. Study Participant Visits
      1. Data Collection and Management
         1. Characteristics of high-quality data
         2. Good Documentation Practices and ALCOA+
      2. Preparation and maintenance of Data
         1. Standard of Care vs. Study specific data
         2. Protocol Timeline
         3. Source documentation and review process
         4. Case report form completion, corrections, errors
         5. Collection of specimens for submission to central collection laboratories
         6. Investigational Product Maintenance
         7. Monitoring dosage modifications and treatment calculations for compliance
         8. Identifying and reporting adverse events
         9. Quality controls and audits
      3. Adverse Events and Reporting
         1. AE, SAE, and Events of Interest
         2. UADE, SUSAR
         3. Process for capturing and assessing AE
         4. Investigator oversight
         5. Reporting and Follow-up
   6. Application of Regulatory, Legal, and Governing Parameters with a Clinical Research Project
   7. Investigational Product Control, Storage, and Dispensing.
      1. Safety Profile of IP
      2. Proper storage, dispensing, and handling of IP
      3. Proper IP destruction procedures
      4. Applicable State and Local Regulations
      5. When IP becomes compromised.
   8. Site Master Files
      1. Essential document checklist
      2. Administrative vs. Patient-related Essential Documents
      3. Source Documents and Case Report Forms
   9. Monitoring Visits
      1. Monitoring Plan
      2. Source Data Verification
      3. Interim Monitoring Visits
      4. Risk-Based Monitoring Approaches
      5. Monitoring letters
      6. Protocol Deviations and Violations
      7. Data Queries and Corrections
      8. Misconduct and Fraud
3. Study Close-Out Procedures
   1. Communication to Participants
   2. Communication to IRB
   3. Communication to Sponsor/CRO

CRC 260IN - Lab Skills and Professional Practice

1. Describe principles of good leadership, management, and mentorship.
2. Describe effective communication methods.
3. Demonstrate aseptic techniques with the current Center for Disease Control (CDC) guidelines on universal precautions
4. Demonstrate performance of vital signs.
5. Demonstrate the process of running a twelve lead electrocardiogram.
6. Describe clinical research coordinator laboratory processes including IATA procedures for shipping dangerous goods, specimen quality assurance.
7. Describe body systems as it pertains to phlebotomy, preparation of a patient, equipment used and procedures in drawing blood.
8. Demonstrate techniques using vacutainer methods and quality assurance standards for phlebotomy
9. Describe ethical behaviors in the workplace.

1. Research Subject Communication
   1. Professional communication and behavior
      1. Professional situations
      2. Tact
      3. Diplomacy
      4. Courtesy
      5. Responsibility
   2. Therapeutic relationships
      1. Impartial behavior
      2. Effective responses to cultural differences
      3. Empathy
   3. Recognizing and responding to verbal and nonverbal communication
      1. Positive body language
      2. Listening skills
      3. Eye contact
      4. Barriers to effective communication
      5. Identifying needs of others
   4. Evaluating and understanding communication
      1. Observation
      2. Active listening
      3. Feedback
   5. Interviewing techniques
      1. Interviewee  (subject, family member, other)           
      2. Setting (office, telephone, hospital)
      3. Guiding, controlling and ending interviews
         1. Using questions – exploratory, open-ended, direct
         2. Legal restrictions
2. Research Subject Encounter
   1. Clinical treatment setting vs. research protocol setting
   2. Subject History
      1. Role of the Principal Investigator
      2. Components of a standard medical chart
   3. Patient Diary
   4. Medication Changes
      1. Subject reporting
      2. Documentation
   5. Adverse Events & Serious Adverse Events
      1. Subject reporting
      2. Documentation
   6. Vital Signs
      1. Performing
         1. Body Temperature
         2. Pulse Rate
         3. Blood Pressure
         4. Respiratory Rate
      2. Recording
3. Electrocardiography
   1. Review of the anatomy and physiology of the heart
   2. Function of the EKG machine
   3. Proper use of the EKG machine
   4. Normal anatomy of the chest wall for proper lead placement
   5. Lead placement and other clinical practices
   6. Practicing EKG
4. Clinical Research – Laboratory
   1. Laboratory Issues for Clinical Research
      1. Role of the Clinical Research Coordinator
      2. Variety of clinical trial settings
      3. Laboratory specifications within study protocols
   2. Phlebotomy - blood collecting
      1. Review of the circulatory system
      2. Veins suitable for phlebotomy
      3. Minimizing biohazard exposure
      4. OSHA safety standards
      5. Blood collecting equipment and supplies
      6. Preparing subjects for blood collection & proper infection control
      7. Steps in venipuncture process
      8. Complications associated with blood collection
      9. Proper postpuncture care
      10. Practicing venipuncture on medical mannequins
   3. Specimen Processing, Storage and Shipping
      1. Quality assurance and control
      2. Proper disposal of needles, sharps and medical waste
      3. Appropriate procedures for processing blood containers
      4. Infectious substance shipping guidelines per IATA procedures

CRC 273 - Clinical Trial Operations

3 Credits, 3 Contact Hours
3 lecture periods 0 lab periods

Knowledge of Clinical Operations in order to run a clinical trial.  Elements discussed include the financial, personnel, legal, and procedural aspects of implementing, monitoring, conducting, and managing a clinical trial.  

Corequisite(s): CRC 250IN  
 

1. Describe the necessary steps to implement a clinical trial.
2. Describe the elements of a study budget as it relates to the execution of a protocol.
3. Explain the variety of electronic clinical technologies and tools used to automate, enhance, and streamline clinical study conduct.
4. Describe the Management and Training approaches to mitigate risk during a clinical trial.
5. Identify the legal responsibilities and accountabilities of conducting a clinical trial.

A. Site and Protocol Feasibility

B. Site Approval Processes

C. SOPs

D. Approval from Stakeholders

II. Developing a Research Study Budget

A. Developing a Study Plan

B. Elements of a Study Budget and the Protocol

1. Estimating study costs and a site budget

2. Analyzing the budget components for a specified clinical trial relative to cost effectiveness

3. Third Party Vendors, Certificates, and Credentials

4. Assisting in the calculations of an overall research project budget, including personnel, costs, overhead, and profit margin

5. Components of a typical bid, proposal, and contract

III. Management and Training Approaches  to mitigate risk

A. Delegation of Responsibility

1. Roles of Study Team Members

2. Staff Qualifications

3. Training and Documentation

4. Updating the Delegation Log during the trial.

B. Corrective and Prevention Action Plans

1. Risk Assessment

2. Root Cause Analyses

C. Implementation Analysis and Operational Considerations

1. Site recruitment and selection

a. Dedicated Personnel

a. Advertising Strategies

b. Pre-Screening and Screening Strategies

2. Investigational product shipment and storage

a. Procedures for accepting IP

b. Storage considerations

c. Product Accountability

d. Participant Instructions

e. Quarantine Considerations

D. The well-coordinated research project

1. PI Oversight

2. Study Procedures

a. Administrative

b. Clinical

3. Training

a. Implementation

b. Record-keeping

c. Maintenance of 

4. Facilities

a. Safety

b. Ergonomics

5. Equipment

a. Maintenance and Calibration Records

b. Inventory

6. Office and Clinical Supplies

7. Data Collection and Entry

a. Personnel and Responsibilities

b. Timeliness of Data Entry

c. Queries

d. Good Documentation Practices

8. Trial Compliance

a. IRB

b. DSMB

c. FDA 

IV. Legal Responsibilities, Liabilities, and Accountabilities  

A. Clinical Trial Agreement (CTA)

1. Execution of the CTA and the trial.

2. Insurance or Indemnification and the CTA

3. Mitigating Risk and Liabilities

a. Business Risks

b. Regulatory Sanctions

c. Civil Penalties

d. Criminal Prosecution

CRC 275 - Leadership for Health Professionals

2 Credits, 2 Contact Hours
2 lecture periods 0 lab periods

Focuses on theory and concepts associated with self-leadership and professionalism and implementation strategies. Includes organizational strategies, effective communication, professional and leadership theories for ethical decision-making in the delivery of quality healthcare. 

Information: Based on proven strategies, this course will help you learn, appreciate, and use your talents and strengths as new professionals and individual leaders.
 

1. Apply the principles and practices of leadership and mentorship to the clinical setting.
2. Demonstrate cultural competency to improve communication and study engagement with a diverse patient population
3. Synthesize ethical and professional conflicts and how they can be mitigated or prevented.
4. Role-play using the clinical professional guidelines and codes of ethics

1. Develop personal leadership values, strengths, and weaknesses
2. Define Unconscious Biases
3. Role-play Crucial Conversation Techniques
4. Articulate the behavioral practices (patterns of action) of effective professionals

A. Active Listening

1. Types of Listeners

2. Techniques

3. Barriers to Active Listening

4. Exploring other types of Listening

   a. Critical

   b. Empathetic

   c. Results-centered

   d. Expansive

B. Writing Professionally

1. Reports and Medical Records

2. Email and electronic communication

3. Patient Education

C. Speaking Effectively

         1.  Patient Education

         2. Team and Peers

         3. Cultural Diversity

         4. Crucial Conversations

D. Presentations and Public Speaking

1. 10:20:30 Rule

2. Perfect Presentation

3. Building Confidence

II. Fundamentals of Collaboration

A. Working Cooperatively

B. Accountability

III. Information and Media

A. Facts, Stats, and Data

B. Ethics

C. Misinformation

IV. Emotional Intelligence

A. Self-Awareness & Self-Regulation

B. Motivation

C. Empathy

D. Social Skills

V. Anatomy of Exceptional Leadership

A. The other Q’s

1. IQ

2. FQ

        B. 3-H Leadership

CRC 291 - Clinical Research Coordinator Internship

1. Apply research project coordination concepts and practices to clinical trial projects in a    research setting.
2. Demonstrate appropriate use of research and medical terminology.
3. Simulate the recruitment, enrollment and retention procedures for study participants.
4. Perform the review of study participant’s file data for completeness and accuracy. 
5. Demonstrate professional workplace behavior, i.e. appearance, attitude, communication and respect for team members and study participants. 
6. Analyze and critique, in writing, internship experiences at the research sites.

1. Observing and Performing Clinical Research Activities at the Different Research Sites
2. Participating in and Implementing New or Ongoing Clinical Research Activities
3. Completing Selected Clinical Research Compliance Evaluation Activities
4. Adjusting Applications of Knowledge, Practices, Protocols, Procedures and Behaviors as Recommended
5. Completion of Assignments Designated by Site Mentor and Instructional Faculty
6. Participation in Self-Assessment of Performance with Site Mentor/Instructional Faculty

CRC 296 - Clinical Research Independent Study: Clinical Project