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 102 - Introduction to Research Data

1. Describe the role of statistics and informatics in clinical trials.
2. Describe the origin, flow, and management of data through a clinical trial.
3. Describe communication methods to stakeholders about study findings.
4. Review data collection forms for completeness and accuracy.

1. Coordination and Organization of Patient Data for a Clinical Research Project
   1. Clinical data management process for clinical trial
   2. Elements of a data management plan
   3. Appropriate database design and its development
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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 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 to the body as a whole to the names, locations and functions of the major organs of the body systems
3. Describe the terms utilized for the major disease processes including symptoms, diagnosis, diagnostic testing, surgeries, and therapies
4. Define basic terms and abbreviations used in documenting medical records
5. Use common terms and abbreviations in documenting medical records related to the major systems of the body
6. Define the MedDRA System Organ Class and the grading system used in Adverse Event severity.
7. Define an Adverse Event using the CTCAE guidance
8. Describe the Activities of Daily Life Instrument

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, prefixes, and suffixes 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 terminology
3. Terms Pertaining to the Body as a Whole
   1. Terms that apply to the structural organization of the body
   2. Body cavities and the organs contained within those cavities
   3. Anatomical and clinical divisions of the abdomen
   4. Anatomical divisions of the back
   5. Terms that describe positions, directions, and planes of the body
   6. Definitions for new word elements, using them to understand new medical terms
4. Organs of Each System
   1. Disease process and symptoms
      1. Skeletal  System
      2. Muscular System
      3. Nervous System
      4. Respiratory System
      5. Cardiovascular System
      6. Digestive System
      7. Excretory and Urinary System
      8. Endocrine System
      9. Immune and Lymphatic System
      10. Integumentary System
      11. Reproductive System (male and female)
      12. Sensory System
   2. Combining forms and the meaning of the related terminology (using these word parts)
      1. Skeletal  System
      2. Muscular System
      3. Nervous System
      4. Respiratory System
      5. Cardiovascular System
      6. Digestive System
      7. Excretory and Urinary System
      8. Endocrine System
      9. Immune and Lymphatic System
      10. Integumentary System
      11. Reproductive System (male and female)
      12. Sensory System
   3. Application of medical terms for the proper collection of adverse events and medical history
      1. Skeletal  System
      2. Muscular System
      3. Nervous System
      4. Respiratory System
      5. Cardiovascular System
      6. Digestive System
      7. Excretory and Urinary System
      8. Endocrine System
      9. Immune and Lymphatic System
      10. Integumentary System
      11. Reproductive System (male and female)
      12. Sensory System
   4. Special Interest areas:
      1. Congenital, familial, and genetic disorders
      2. Injury, poisoning, and procedural complications
      3. Investigations
      4. Social circumstances
      5. Surgical and medical procedures
5. Understand the System Organ Class Using the MedDRA System
   1. Discover MedDRA
   2. System Organ Class (SOC)
   3. High Level Group Term (HLGT)
   4. High Level Term (HLT)
   5. Preferred Term (PT)
   6. Lowest Level Term (LLT)
6. Apply the Medical Terminology to the CTCAE
   1. Locate a medical condition(s) or disorder
   2. Medical terminology within the CTCAE
   3. Severity of the condition or disorder
   4. Activities of Daily Life instrument

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 - Introduction to Clinical Research Study Protocol

1. Explain Inclusion/Exclusion criteria
2. Explain the difference between standard of care and trial activities in relation to protocol
3. Differentiate among the various types of research designs and concepts, including the protocol elements used in each design.
4. Compile the Regulatory requirements for study start-up.
5. Develop an Informed Consent Form using the Research Protocol.

1. Explain the study background and rationale for a clinical trial
2. Explain the purpose of an Investigators Brochure and instructions for use
3. Describe the key elements contained within essential documents
4. Identify the study hypothesis, objectives, and endpoints for a variety of clinical trials
5. Explain professional guidelines and code of ethics as they apply to the role of the CRC

1. Scientific Approach Applied to Development of Research Protocol
   1. Overall process of clinical research development
   2. Classifications of clinical trial designs in Phases I-V
   3. Regulatory requirements for protocol development as specified in the FDA regulations, IND and ICH guidelines
   4. Development of appropriate research hypotheses specific to each phase of protocol development
2. Key Elements Addressed in a Research Protocol
   1. Background information including a synopsis of the properties of the investigational product
   2. Study objectives and purpose
   3. Study design
   4. Selection of subject and precedent for subject withdrawal
   5. Study procedures and treatment of subjects
   6. Efficacy methods and assessment parameters
   7. Safety assessment parameters
   8. Statistical methods to be used in analyzing data
   9. Statement concerning direct access to source data and documents
   10. Quality control and quality assurance methods
   11. Ethical concerns related to the study including informed consent
   12. Data handling methods
   13. Indemnification statement, insurance requirements and financial arrangements with investigator
   14. Statement of sponsor’s publication policy
   15. Protocol amendments
3. Research Designs and Concepts
   1. Types of research designs
   2. Types of control groups
   3. Ways to randomize for a clinical trial
   4. Ways to blind a clinical trial
   5. Control of bias in clinical trials
4. Ethical Considerations and Issues
   1. Ethical principles consistent with Good Clinical Practices (GCP) and Federal Regulations
   2. Scientifically sound hypotheses and treatment procedures
   3. Rights of study subject
   4. Foreseeable risks and unexpected events
   5. IRB approval and the informed consent process
   6. “Unblinding” rules and procedures
   7. Scientific misconduct
5. Identify the Differences in Study Design Approaches
   1. Prospective
   2. Retrospective
   3. Combination

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 250IN - Clinical Research Site Coordination and Management

1. Coordinate and manage an identified clinical research project from study start-up to study close-out.
2. Explain the elements of the study budget as it relates to the execution of a protocol.
3. Prepare a recruitment plan to recruit and retain study subjects
4. Develop a management plan for the research site project
5. Collect and record data into an electronic data capture system

1. Coordinating an Identified Clinical Research Project
   1. Development of an overall plan for a specified clinical research project
   2. Elements of Project Management
   3. Developing a detailed plan (including time lines) for each phase of the clinical research project
   4. Effective communication needed between project team members and clinical trial management
   5. Decision-making process for accepting and conducting a research project
   6. Importance, design, and use of set timelines in a research project
   7. Study goals and deadlines for clinical research trials
   8. Operational Site Management
   9. Drafting Standard Operating Procedures
   10. Implementing Corrective and Preventive Action Plans
   11. Quality Audits
   12. Quality Controls
   13. Mitigating problems that can commonly occur between clinical research sites and Sponsors/Contract Research Organizations
2. Planning and Preparation of Research Budgets and Contracts
   1. Process involved in the development of a research study budget
   2. Routine calculations associated with the costs of a clinical research trial
   3. Analysis of budget components for a specified clinical trial relative to cost effectiveness
   4. Assisting in the calculations of an overall research project budget, including personnel costs, overhead, and profit margin
   5. Funding sources for clinical research project
   6. Role and responsibility of a clinical research investigator and coordinator in the development of a research contract
3. Application of Regulatory, Legal, and Governing Parameters with a Clinical Research Project
   1. Function, activities, and responsibilities of an Institutional Review Board (IRB)
   2. Requirements for membership on an IRB according to the Code of Federal Regulations, Title 21 (21 CFR 56.107)
   3. Maintaining and retaining of IRB records
   4. IRB submission process and the standard review criteria used by an IRB
   5. “Expedited review criteria”
   6. Communication responsibilities between the investigator and the IRB
   7. Eight basic elements of an informed consent form according to Good Clinical Practice (GCP) and Federal regulations and development of a sample consent form
   8. Study file record retention and requirements
   9. Contractual relationships in a clinical research project or study
   10. Study document checklist
   11. How to complete a form FDA-1572
   12. Elements needed in a current curriculum vitae
   13. Regulatory documents needed prior to shipping investigational supplies
   14. Sample regulatory packet for a clinical research project or study
   15. Regulatory, patent and legal considerations in protocol design
   16. Scientific misconduct and its consequences
4. Management of Research Sites
   1. Basic procedures and tasks needed to implement a clinical study including recruiting, budgeting, and timelines
   2. Qualifications for the investigator, study coordinator, and other site personnel in conducting research in Phase I, Phase II, and Phase III clinical trials
   3. Responsibilities and roles of key personnel participating in the management of a research site
   4. Regulatory/essential documents required of a research site
   5. Databases, logs, and files utilized in the maintenance of a study site
   6. Differences between the roles of a site coordinator and a monitor in the preparation, maintenance, and submission of required reports
5. Recruitment, Enrollment and Retention of Study Subjects
   1. Ethical considerations involved in human experimentation
   2. Subject recruitment plan 
   3. Informed consent from study participants
   4. Subject participation according to established protocols
   5. Collection of specimens for submission to central collection laboratories
   6. Monitoring dosage modifications and treatment calculations for compliance
   7. Identifying and reporting adverse drug reactions according to study guidelines and reporting requirements
   8. Preparation and maintenance of required records and follow-up on protocol subjects
   9. Regulatory document binders; study files and manuals with new studies; amendments; and closure notices
6. Data Collection and Management
   1. Purpose of source documentation
   2. Source document review process
   3. Case report form completion
   4. Characteristics of high-quality data
   5. Case report form corrections, errors and queries
   6. Electronic data capture
   7. Data security
   8. Internal quality assurance
   9. Audit preparation
   10. Archiving data

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 270 - Research Management for Sponsors and CRO’s

1. Identify professional and behavioral skills required of the Clinical Research Associate (Monitor).
2. Discuss the relationship between Sponsor, CRO, and the clinical research site.
3. Develop a plan for data quality assurance.
4. Communicate effectively to CRC during the Site Initiation Visit, Interim Monitoring Visit, and Close-Out Visit
5. Evaluate research data for completeness, compliance, and accuracy
6. Define on-site, centralized, remote, and risk-based monitoring visits

1. Professional and Behavioral Skills of the Clinical Research Associate
2. Processes Involved in the Development of a Research Study Budget
   1. Estimating study costs and a site budget
   2. Analyzing the budget components for a specified clinical trial relative to cost effectiveness
   3. Assisting in the calculations of an overall research project budget, including personnel, costs, overhead, and profit margin
3. Planning a Clinical Research Trial from the Perspective of a Clinical Research Associate   
   1. Types of CROs
   2. Components of a typical bid, proposal, and contract with CRO
   3. Role and responsibility of a Clinical Research Associate in the development of a research contract with a CRO
   4. Delegation of responsibilities and outsourcing to a CRO and considerations for this relationship
   5. Communication between project team members and clinical trial management
   6. Problems commonly occurring between CROs and clients (Sponsors)
   7. Design of study Case Report Forms  (CRF)
   8. Implementation of start-up activities including:
      1. Site recruitment and selection
      2. Essential document collection and approval
      3. Investigational product shipment
   9. Set timelines in a well-coordinated research project
4. Planning, Preparation, and Conduction of Evaluation, Initiation, Periodic Monitoring, and Termination Study Site Visits                                                                                               
   1. Development and critical elements of a monitoring plan for a typical study
   2. Various study visits and development of an agenda for each type
   3. Challenges experienced by a monitor while traveling on site visits
   4. Responsibilities of the monitor and the site personnel for each type of visit
   5. Components needed in a summary report for each type of site visit
   6. The roles and responsibilities of the site coordinator and the monitor relative to subject data documentation and verification
   7. Source documentation
   8. Case report forms
   9. Process for reporting adverse events and serious adverse experiences
   10. Development of a database for each study subject visit
   11. Development of a monitoring report providing feedback to the investigator and site coordinator
5. Effective Management of Research Sites
   1. Basic procedures and tasks needed to implement a clinical study at a given study site
   2. Responsibilities and roles of key personnel participating in the management of a research site
   3. Qualifications for the investigator, study coordinator, and monitor in conducting research in Phase I, Phase II, and Phase III clinical trials
   4. Regulatory documents required of a research site
   5. Development of an investigator questionnaire/survey for recruitment purposes
   6. Development of a study subject recruitment plan
   7. Development of source documentation templates
   8. Development of sample procedures for the management of a research site, including recruiting, budgeting, and timelines
   9. Databases, logs, and files utilized in the maintenance of a study site
   10. Determination of the quality performance of a research site
   11. Different roles of a monitor and the site in the preparation, maintenance, and submission of required reports
6. Evaluation of Research Data for Completeness, Compliance, and Accuracy
   1. Source document verification on typical study cases
   2. Data collection forms for completion and accuracy
   3. Essential document collection during the course of a clinical trial
   4. Assessment of pertinent data for a specified research publication
   5. Review research data for subject safety
7. Preparation for and Conduct of the Sponsor Quality Assurance (QA) Audit
   1. Differences between a monitoring visit and a sponsor audit
   2. Purpose of a QA audit and typical findings
   3. Preparation for a QA audit
   4. Assessment of outcomes of audits
   5. Examples of instances of scientific misconduct

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