Department of Interdisciplinary Studies

IDST 1240 Introduction To Clinical Research

2016: Marilyn Donahue

Course Description

This course is designed to provide students with a basic understanding of what clinical research is and the scientific principles on which it is based. The course starts with a historical perspective on clinical research and then goes on to explore in detail the following topics: purpose and phases of clinical research, clinical trial development and conduct, ethical and regulatory implications, and the roles and responsibilities of all parties involved in clinical research.

Credits/Modes of Instruction

This is a 3-credit undergraduate course in lecture format that relies on regular activities, assignments, and completion of weekly topics.

Prerequisites Successful completion of the following two courses: Dynamics of Health Care in Society and Medical Terminology

Instructor The instructor will be a Rutgers-SHP faculty (or adjunct) member.

Course Goals and Objectives: Goals The goal of this course is to provide students with the fundamentals of clinical research focusing on its purpose, development, regulations, and implications in healthcare.

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Objectives After completion of this course, students will be able to:

1. Describe the purpose and functions of clinical research and how they have evolved over time. 2. Provide a basic explanation of various study designs and utilize this information to evaluate peer-reviewed, published clinical research. 3. Discuss how ethics is relevant to clinical research and describe the ethical principles which guide clinical research. 4. Describe the regulatory and safety measures in place to protect human subjects in clinical research. 5. Identify the various organizations and personnel involved in clinical research and explain their functions and roles. 6. Explain how a clinical trial protocol is developed and implemented. 7. Discuss the critical role of data management in research and what factors drives this process. 8. Describe the processes and entities in place to ensure clinical quality control and drug safety.

Course Requirements for Completion Attendance is required to keep up with the information presented in class. Students will be expected to participate in classroom discussions and group activities. Each course unit will include readings, assignments, and a short quiz. In addition, successful completion of the four course projects will be required. There will be a cumulative final exam based on class content and assigned readings.

Requirements Weight

Attendance/Participation/Group Discussion 10%

Unit Assignments/Homework 10%

Unit Quizzes 20%

Course Projects • Informed Consent Document • Journal Club Presentation • Clinical Trial Protocol Design • Careers in Clinical Research Assignment

40%

Final Examination 20%

Total 100%

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Evaluation, Feedback and Grading Evaluation/Assessment Methods

• Attendance/Participation/Group Discussion – Students are expected to attend all classes and participate in classroom discussions and group activities.

• Unit Quizzes: Students will be required to take a short quiz at the completion of each unit. Content will be based on lectures, readings, and classroom discussions/activities.

• Unit Assignments – Each unit will have specific assignments geared to meet unit objectives. These assignments can be completed as homework or in class, as time permits.

• Course Projects – There will be four major projects due throughout the course. Each project will have specific directions for completion and students are expected to work individually on these projects.

• Final Examination – Successful completion of a cumulative final exam at the end of the course is required. Feedback on Progress Students will receive feedback on their performance on a regular basis. Quantitative and qualitative feedback will be provided for all assignments, quizzes/tests, and projects. Grade Determination The minimum level of satisfactory performance in this course is a ‘C’ or better. To receive a ‘C’ or better, students must first complete ALL course requirements specified above, including meeting the minimum attendance expectation. Based on the evaluations methods and criteria previously described, each requirement is then scored on a 0-100 point scale. The final letter grade is based on the weighted average of all requirements.

Upon successful completion of the course students will be eligible to take the Health Science Careers standardized exam to determine college credit. All students must attain a C (73) or better to earn college credits. Minimum passing standardized exam grade for all students must be at least 70 before calculations of college transcript grade can be determined. The Rutgers grade listed on the student’s transcript will be comprised of 50% of the Rutgers SHP standardized exam grade and 50% of the high school course grade.

Health Science Careers Program Grading System

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Weighted Average of All

Requirements

Final

Letter

Grade

93-100 A

90-92.9 A-

87-89.9 B+

83-86.9 B

80-82.9 B-

77-79.9 C+

73-76.9 C

70-72.9 C-

67-69.9 D+

63-66.9 D

Less than 63 F

Faculty/Student Honor Code

(Refer to your SHP Student Handbook at http://SHP.umdnj.edu/current_students/handbook.pdf)

The faculty of Rutgers-School of Health Related Professions believe that students must observe and support high standards of honesty and integrity in all aspects of education, practice, and research. For this reason, all matriculated and non-matriculated students in this course are expected to abide by the School's Faculty/Student Honor Code and accept responsibility to help ensure that these standards are maintained by reporting violations of the Honor Code observed in others. All violations will be considered with gravest concern and may be punishable with sanctions as severe as suspension or dismissal.

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General Learning Resources Required Textbook(s): Jacobsen, Kathryn H. Introduction to Health Research Methods: A Practical Guide. 2012. Jones and Bartlett Learning, 5 Wall Street, Burlington, MA. 2012. (ISBN:13:978-0-7637-8334-1) Nesbitt, L. Clinical Research: What It Is and How It Works. Boston, MA: Jones and Bartlett Publishers. 2004. (ISBN: 0763731366) Highly Reccomended: J. Dennis Blessing and J. Glenn Forister. Introduction to the Research and Medical Literature for Health Professions, Third Edition 2013. Jones and Bartlett Learning, 5 Wall Street, Burlington, MA 01803 (ISBN: 978-1-4496-5033-3) Gallin, J., Ognibene, F. Principles and Practice of Clinical Research, 2nd Edition. Boston, MA: Academic Press/Elsevier. 2007. (ISBN: 9780123694409)

National Institute of Health “Introduction to the Principles and Practice of Clinical Research” online course offered internationally. http://clinicalcenter.nih.gov/training/training/ippcr.html Archives of chapter lectures are available to all. Uses the Principles and Practice of Clinical Research, 2nd Edition . https://ippcr.nihtraining.com/archive.php?year= 2011 Other Required Learning Resources Various website links will be provided in the Learning Resources section for each unit in the Course Schedule. Students are required to access these websites for completion of assigned readings and activities. New Jersey Core Curriculum Content Standards (CCCS) are referenced and available at these links: http://www.state.nj.us/education/cccs/2014/career/CareerReadyPractices.pdf Career Readiness http://www.state.nj.us/education/cccs/2014/career/91.pdf Career Awareness, Exploration, and Preparation http://www.state.nj.us/education/cccs/2014/career/93.pdf Career and Technical Education http://www.corestandards.org/ELA - Literacy/RST/11 - 12/ English Language Arts Standards/ Science and Technical Subjects 11- 12 th Grade http://www.corestandards.org/ELA - Literacy/WHST/11 - 12/ English Language Arts Standards/ Writing in History, Social Studies, Science & Technology Grades 6-12

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Course Units/Schedule Note: this schedule is a plan only, subject to change by the instructor as deemed necessary to achieve the course goals. Whenever possible, you will be notified in advance of any changes, especially those affecting course requirements or grading.

Unit/ Begin Date

Topical Outline Learning Resources Activities/Assignments Assessments

NJCCCS 21st Century Life and

Careers

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Unit 1 History of Clinical Research • Define clinical research • Explore the evolution of clinical

research from the beginnings of civilization.

• Discuss key historical research cases and how they have contributed to advances in medicine and shaped today’s version of the clinical trial.

• Discuss current research.

Read: • Jacobsen – Chapter 1 • Gallin – Chapter 1: A

Historical Perspective on Clinical Research https://webmeeting.nih.gov/p52141191/

• The Tuskegee Timeline. Centers for Disease Control and Prevention – US Public Health Service Syphilis Study at Tuskegee - http://www.cdc.gov/tuskegee/timeline.htm

• Research Implications. Centers for Disease Control and Prevention – US Public Health Service Syphilis Study at Tuskegee - http://www.cdc.gov/tuskegee/after.htm

Review/Listen: • http://faculty.pingry.org/bpo

prik/documents/TuskegeeEx periment.pdf “Remembering Tuskegee - Syphilis Study Still Provokes Disbelief,

Group Classroom Discussion: Open the class with a discussion of what clinical research is. Explore the students’ perceptions of the following: -What is the definition of clinical research? -What is the purpose of clinical research? - What are the benefits of conducting clinical research? Optional Lesson Extension: Movie “Miss Ever’s Boys” Complete Unit 1 Quiz

9.3.HL BRD.1 Summarize the goals of biotechnology research and development within legal and ethical protocols. CRP5. Consider the environmental, social and economic impacts of decisions (in research).

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Sadness Tuskegee Documentaries: https://www.youtube.com/watch?v= FFWiLKA - 91s 10 minute video https://www.youtube.com/watch?v= qNa8CnC4sSU NOVA episode “The Deadly Deception”

Unit 2

Overview of Clinical Research • Know what research is and is

not. • Define clinical research and its

purpose. • Describe various types of

research study designs including observational studies and clinical trials.

• List and describe the five basic steps of the research process.

• Explain the key elements of the four phases of clinical trials.

Read: • Nesbitt – Chapter 1 • Understanding Research

Study Designs. University of Minnesota – BioMedical Library -

• http://hsl.lib.umn.edu/biome d/help/understanding research - study - designs

• Understanding Clinical

Trials. Clinical Trials.gov- National Institutes of Health - http://clinicaltrials.gov/ct2/info/understand#Q01

• Jacobsen - Chapter 1-29 (Pg. 10)

Step one - Chapter 2 Step two - Chapter 6 Step Three - Chapter 15 Step Four - Chapter 25 Step five - Chapter 29

Homework/Assignment: New Terminology Terms to know: Study Designs Clinical Study Interventional Study Observational Study Case Control Case Series Ecological Study Aggregate Study Meta-analysis Longitudinal Cohort Study Retroactive Cohort Cross-sectional Double-blind Study Randomized Control Trials Population Based Research Complete Unit 2 Quiz

9.3.HL BRD.1 Summarize the goals of biotechnology research and development within legal and ethical protocols. 9.3.HL BRD.5 Determine processes for product design and production and how that work contributes to an understanding of the biotechnology product development process.

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Project

Chose a Clinical Research Article for the Journal Club Project and related assignments

Some Suggested Databases: PubMed CINHAL EbscoHOST Search for and obtain a complete text article

Chose your topic. Log on to research databases, select complete text only filter. Be sure to choose a clinical research article, not an observational or behavioral research article. Download your article and forward your topic and complete article to instructor via email.

CRP2. Apply appropriate academic and technical skills. CRP7. Employ valid and reliable research strategies. CRP8. Utilize critical thinking to make sense of problems and persevere in solving them. CRP11. Use technology to enhance productivity.

Unit 3 Ethics in Clinical Research • Discuss principles of the ethical

framework for clinical research: Value and Validity, Fair Subject Selection, Favorable Risk-Benefit Ratio, Independent Review, Informed Consent, and Respect for Enrolled Subjects.

• Describe the purpose of a Patient Informed Consent Form.

• Identify the key information included in Patient Informed Consent forms. Explain the role and functions of the Investigational Review Board (IRB).

Read: • Nesbitt – Chapter 2 • Jacobsen – Chapter 21 & 22 • Gallin –

Chapters 2 : Ethical Principals in Clinical Research Chapter 5: Institutional Review Boards

• Blessing – Chapter 3,4

Template for Informed Consent Document assignment

http://rbhs.rutgers.edu/hsp/forms/co nsent.html

Project 1: Create an Informed Consent Document based on the article you chose for your Journal Club Project. Homework/ Assignment: Complete Terms to Know. Terms to Know: Ethics Value and Validity Fair Subject Selection Eligibility Criteria Inclusion Criteria Exclusion Criteria Favorable Risk-Benefit Ratio Beneficence Non-malfeasance Justice Respect for Enrolled Subjects Independent Review Informed Consent Institutional Review Board OHRP Office of Human Research Protection

9.3.HL.3 Identify existing and potential hazards to clients, coworkers, visitors and self in the healthcare workplace. 9.3.HL.4 Evaluate the roles and responsibilities of individual members as part of the healthcare team and explain their role in promoting the delivery of quality health care. 9.3.HL.5 Analyze the legal and ethical responsibilities, limitations and implications of actions within the healthcare workplace. 9.3.HL.6 Evaluate accepted ethical practices with respect to cultural, social and ethnic differences within the healthcare workplace.

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Nuremberg Code Belmont Report Plagarism (4 types) Complete Unit 3 Quiz

Unit 4 The Clinical Research Landscape: Regulatory agencies, Research personnel, Research sites, Contract research organizations, the Pharmaceutical industry

• List the various organizations involved in the development and conduct of a clinical trial.

• Describe the role of the Food and Drug Administration in drug discovery and development.

• Identify key clinical research personnel at the study sites.

• Distinguish between governmentsponsored and industry-sponsored clinical research.

• Define the components of the pharmaceutical industry and discuss the challenges under which the components operate.

Read: • Nesbitt – Chapter 3, 9 • Gallin-

Chapter 9 Data and Safety Monitoring Chapter 26 (pg. 350-356) Chapter 37 Pharmaceutical Research

• Blessing – Chapter 11 “Clinical Review” Study Design

Homework/Assignment: Complete Terms to Know Terms to Know: Research Principal Author Principal Investigator FDA IRB Clinical Trial Sponsor CRO Clinical Research Org Study Monitors Terms to Know: Pharmaceutical (Gallin p 546-550) Efficacy Safety Pharmacovigilance Pharmacoeconomics Fast Track Approval Placebo Placebo effect Complete Unit 4 Quiz

9.3.HL.4 9.3.HL.5 9.3.HL BRD.5 Determine processes for product design and production and how that work contributes to an understanding of the biotechnology product development process. 9.3.HL BRD.6 Summarize and explain the larger ethical, moral and legal issues related to biotechnology research, product development and use in society.

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Unit 5 Clinical Research from the Perspective of the Patient

• Explore the reasons that motivate patients to participate in clinical research.

• Explain why certain populations are underrepresented in clinical trials.

• Describe strategies for effective communication with patients in

Read: • Nesbitt – Chapter 7 • Jacobsen – Chapter 19 • Gallin –

Chapter 13 Women and Minorities Lecture from NIH https://webmeeting.nih.gov/p

Class Activity: Vignettes Nesbitt Ch. 7 Ask for volunteers to act out the vignettes in this chapter. Discuss how to manage each of the personalities during a research study.

9.3.HL.6 9.3.HL BRD.6 9.3.HL DIA.4 Explain procedures and goals to the patient/client accurately and effectively, using strategies to respond to questions and concerns. 9.3.HL THR.1 Utilize

clinical research and how this can improve the recruitment process as well as retention.

23416167/?launcher=false&f csContent=true&pbMode=normal Chapter 17 Patient’s Perspective Lecture from NIH https://webmeeting.nih.gov/p 21122676/?launcher=false&fcsContent=true&pbMode=normal

Complete Unit 5 Quiz

communication strategies to answer patient/client questions and concerns on planned procedures and goals. 9.3.HL THR.2 Communicate patient/client information among healthcare team members to facilitate a team approach to patient care.

Class Activity

Ethics Debate Resources for Debate: New York Times & New England Journal of Medicine articles are listed below.

Prepare for and conduct a debate on the ethics of doing research on Pre-term babies. Use debate format from www.HOSA.org Biomedical Debate http://www.hosa.org/sites/defaul t/files/BD13.pdf

9.3.HL.3 9.3.HL.4 9.3.HL.5 9.3.HL.6 9.3.HL BRD.1 9.3.HL BRD.6

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Unit 6

Clinical Trial Protocol and Implementation

• Explain the elements of a clinical trial protocol.

• Develop a concept for a clinical trial and write a protocol concept document to implement it.

• Discuss the processes involved in initiating, maintaining, and closing out a clinical trial.

Read: • Nesbitt – Chapter 4 • Gallin Chapter 32 Writing a

Protocol • Jacobsen – throughout • Blessing – Chapter 5,9

Protocol Guidance: http://rbhs.rutgers.edu/hsp/forms/in dex.html template

Project 2: Design a Clinical Protocol based on the article you chose for the Journal Club project using the template from Rutgers School of Biomedical and Health Sciences.

9.3.HL DIA.1 Communicate key diagnostic information to healthcare workers and patients in an accurate and timely manner. 9.3.HL DIA.2 Assess and report patient’s/client’s health status in order to monitor and document patient progress. 9.3.HL DIA.5 Select, demonstrate and interpret diagnostic procedures. 9.3.HL THR.2 Communicate

Complete Unit 6 Quiz

patient/client information among healthcare team members to facilitate a team approach to patient care. 9.3.HL THR.3 Utilize processes for assessing, monitoring and reporting patient’s/clients’ health status to the treatment team within protocol and scope of practice 9.3.HL THR.4 Evaluate patient/client needs, strengths and problems in order to determine if treatment goals are being met.

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Unit 7 Data Management • Outline the process of patient data

collection in clinical research. • Explain the importance of effectively

monitoring, reviewing, and evaluating patient data.

• Describe various methods of Statistical Analysis

• Describe how the Health Insurance Portability and Accountability Act (HIPAA) regulation applies to research participants.

Read: • Nesbitt – Chapter 5 • Jacobsen Chapter 25 • Blessing – Chapter 14, 15 • Gallin –

Chapter 8: Data Management in Clinical Trials

• HIPAA Research Presentation. U.S. Department of Health and Human Services - http://www.hhs.gov/ocr/priv acy/hipaa/understanding/trai ning/researchppt.pdf

Homework/Assignment: Complete Terms to Know Terms to know: Statistics Odds Ratio (OR) Risk Ratio (RR) Correlation Prevalence Terms to know: Data Validity Reliability Quantitative Data Qualitative Data Feasibility Health Insurance Portability and Accountability Act (HIPAA) Complete Unit 7 Quiz

9.3.HL HI.1 Communicate health information accurately and within legal and regulatory guidelines, upholding the strictest standards of confidentiality. 9.3.HL HI.2 Describe the content and diverse uses of health information. 9.3.HL HI.3 Demonstrate the use of systems used to capture, retrieve and maintain confidential health information from internal and external sources.

Unit 8 Clinical Quality Control and Assurance • Explain the purpose and importance

of quality management. • Identify the steps in preparing for an

Read: Nesbitt – Chapter 6 Quality

Management & FDA

Project 3 Journal Club Assignment Analyze and Critique your

CRP2. Apply appropriate academic and technical skills. CRP5. Consider the environmental, social and

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FDA audit.

Describe the Good Clinical Practice (GCP) guidelines and explain the importance of complying with GCPs in clinical research.

Readiness Chapter 3 p.84-94 GCP

Good Clinical Practice Handbook http://www.niaid.nih.gov/lab sandresources/resources/dmi dclinrsrch/documents/handb ook.pdf

NIH Lecture on the FDA https://webmeeting.nih.gov/p 82113576/?launcher=false&f csContent=true&pbMode=n ormal

chosen research article to the class. Prepare a PPT based on the rubric provided Terms to Know: Good Clinical Practice (GCP) guidelines Complete Unit 8 Quiz

economic impacts of decisions (in research) CRP6. Demonstrate creativity and innovation. CRP11. Use technology to enhance productivity.

Project Journal Club Presentation Individually chosen clinical research article. Rubric

Journal Club Presentation Present your critique of your chosen clinical research article to the class.

CRP2. Apply appropriate academic and technical skills. CRP4. Communicate clearly and effectively and with reason. CRP6. Demonstrate creativity and innovation. CRP11. Use technology to enhance productivity. NJCCCS English Language Arts Standards for Science and Technology: ccss.ela - literacy.rst.11 - 12.1 ccss.ela - literacy.rst.11 - 12.2 ccss.ela - literacy.rst.11 - 12.4 ccss.ela - literacy.rst.11 - 12.5 ccss.ela - literacy.rst.11 - 12.6 ccss.ela - literacy.rst.11 - 12.7 ccss.ela - literacy.rst.11 - 12.8 ccss.ela - literacy.rst.11 - 12.9

Unit 9 Clinical Drug Safety and Adverse Event Reporting

Describe what constitutes a Serious

Read: Jacobsen – Chapters 13 & 22

Homework/Assignment: Complete Review Questions

9.3.HL THR.1 Utilize communication strategies to answer patient/client

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questions

Adverse Event (SAE) and identify the appropriate steps for reporting it.

Discuss the role and functions of Data and Safety Monitoring Boards (DSMB).

Gallin – Chapter 6 (page 75)

Terms to Know:Adverse Events Serious Adverse Event (SAE) Complete Unit 9 Quiz

and concerns on planned procedures and goals. 9.3.HL THR.4 Evaluate patient/client needs, strengths and problems in order to determine if treatment goals are being met.

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Unit 10 Business of Clinical Research • Describe what factors to

consider when establishing and evaluating clinical study budgets.

• Explain the purpose of a Clinical Trial Agreement and discuss the key elements of this document.

Read: • Nesbitt – Chapter 8 • Jacobsen –throughout

textbook

Project 4: Careers in Clinical Research Write paper about a career in research that would be of personal interest. Complete Unit 10 Quiz

CRP5. (re: research budgets) 9.1.12.A.3 Analyze the relationship between various careers and personal earning goals. 9.1.12.A.4 Identify a career goal and develop a plan and timetable for achieving it, including educational/training requirements, costs, and possible debt. CRP7. Employ valid and reliable research strategies. CRP8. Utilize critical thinking to make sense of problems and persevere in solving them. CRP10. Plan education and career paths aligned to personal goals. NJCCCS English Language Arts Standards for Writing: ccss.ela - literacy.whst.11 - 12.1 ccss.ela - literacy.whst.11 - 12.1.d ccss.ela - literacy.whst.11 - 12.2 ccss.ela - literacy.whst.11 - 12.2.a ccss.ela - literacy.whst. 11 - 12.2.b ccss.ela - literacy.whst.11 - 12.2.c ccss.ela - literacy.whst.11 - 12.2.d ccss.ela - literacy.whst.11 - 12.2.e ccss.ela - literacy.whst.11 - 12.4 pccss.ela - literacy.whst.11 - 12.5 ccss.ela - literacy.whst.11 - 12.6 ccss.ela - literacy.whst.11 - 12.7 ccss.ela - literacy.whst.11 - 12.8

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Unit 11 Writing and Publishing in the Health Professions

• Identify what is written in an abstract. • Identify the types of presentations. • Understand the need for disseminating

one’s research findings.

• Understand how to write a wellprepared research paper and the components of a research paper

Read: • Jacobsen – Chapter 29 –

35 These chapters in Jacobsen cover the entire publication process

• Blessing Chapter 18 This chapter is a concise summary of the dissemination of research findings

Homework/Assignment: Discuss the ways research results are shared, and which methods would be attainable for undergraduate students to publish or present their work? Complete Unit 11 Quiz

CRP2. Apply appropriate academic and technical skills. CRP6. Demonstrate creativity and innovation. CRP11. Use technology to enhance productivity.

Ethics Debate Resources: In defense of research on pre-term babies and the study in question New England Journal of Medicine http://www.nejm.org/doi/pdf/10.1056/NEJMoa0911781 May 27, 2010 Original Research Article Oxygen Saturation and Outcomes in Preterm Infants http://www.nejm.org/doi/pdf/10.1056/NEJMc1304827 Correspondence: Letters to the editor http://www3.med.unipmn.it/intranet/papers/2013/NEJM/2013 - 05 - 16_nejm/nejme1304996.pdf Editorial http://www.nytimes.com/2013/04/19/opinion/consent - forms - in - a - clinical - trial - of - premature - babies.html?src=xps Doctors Respond to The New York Times Editorial http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=6306&blogid=140 Bioethics Forum Defends Research http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/38551 Authors defend research In opposition to research on pre-term babies and the alleged lack of informed consent in the study The New York Times http://www.nytimes.com/2013/04/11/health/parents - of - preemies - werent - told - of - risks - in - study.html?src=xps News Article http://www.nytimes.com/2013/04/16/opinion/an - ethical - breakdown - in - medical - research.html Editorial http://pediatrics.aappublications.org/content/129/3/480.full.html Enrollment in study may not be representative http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf Department Health and Human Services (DHHS) Letter of Reprimand Follow-up research http://www.nejm.org/doi/pdf/10.1056/NEJMoa1302298 May 5, 2013 Original Research Article Oxygen Saturation and Outcomes in Preterm Infants BOOST-II Recruitment stopped early https://www.npeu.ox.ac.uk/boost/clinician - updates https://www.npeu.ox.ac.uk/downloads/files/boost/clinition - updates/BOOSTII - Study - Update --- Clinicians --- 2011 - 04.pdf 17

Appendix A New Jersey Core Curriculum Content Standards (CCCS) used in Introduction to Clinical Research.

21st Century Life and Careers / Career Ready Practices Career Ready Practices describe the career-ready skills that all educators in all content areas should seek to develop in their students. They are practices that have been linked to increase college, career, and life success. Career Ready Practices should be taught and reinforced in all career exploration and preparation programs with increasingly higher levels of complexity and expectation as a student advances through a program of study. CRP2. Apply appropriate academic and technical skills. CRP4. Communicate clearly and effectively and with reason. CRP5. Consider the environmental, social and economic impacts of decisions. [in research, in budgets, in career choices] CRP6. Demonstrate creativity and innovation. CRP7. Employ valid and reliable research strategies. CRP8. Utilize critical thinking to make sense of problems and persevere in solving them. CRP10. Plan education and career paths aligned to personal goals. CRP11. Use technology to enhance productivity.

21st Century Life and Careers / Financial Literacy (9.1) 9.1.12.A.3 Analyze the relationship between various careers and personal earning goals. 9.1.12.A.4 Identify a career goal and develop a plan and timetable for achieving it, including educational/training requirements, costs, and possible debt.

21st Century Life and Careers / Career and Technical Education Standards (9.3) / Health Science Career Cluster CAREER CLUSTER: HEALTH SCIENCE (HL) 9.3.HL.3 Identify existing and potential hazards to clients, coworkers, visitors and self in the healthcare workplace. 9.3.HL.4 Evaluate the roles and responsibilities of individual members as part of the healthcare team and explain their role in promoting the delivery of quality health care. 9.3.HL.5 Analyze the legal and ethical responsibilities, limitations and implications of actions within the healthcare workplace. 9.3.HL.6 Evaluate accepted ethical practices with respect to cultural, social and ethnic differences within the healthcare workplace. PATHWAY: BIOTECHNOLOGY RESEARCH & DEVELOPMENT (HL BRD) 9.3.HL BRD.1 Summarize the goals of biotechnology research and development within legal and ethical protocols. 9.3.HL BRD.5 Determine processes for product design and production and how that work contributes to an understanding of the biotechnology product development process. 9.3.HL BRD.6 Summarize and explain the larger ethical, moral and legal issues related to biotechnology research, product development and use in society. PATHWAY: DIAGNOSTIC SERVICES (HL DIA) 9.3.HL DIA.1 Communicate key diagnostic information to healthcare workers and patients in an accurate and timely manner. 9.3.HL DIA.2 Assess and report patient’s/client’s health status in order to monitor and document patient progress.

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9.3.HL DIA.4 Explain procedures and goals to the patient/client accurately and effectively, using strategies to respond to questions and concerns. 9.3.HL DIA.5 Select, demonstrate and interpret diagnostic procedures. PATHWAY: HEALTH INFORMATICS (HL HI) 9.3.HL HI.1 Communicate health information accurately and within legal and regulatory guidelines, upholding the strictest standards of confidentiality. 9.3.HL HI.2 Describe the content and diverse uses of health information. 9.3.HL HI.3 Demonstrate the use of systems used to capture, retrieve and maintain confidential health information from internal and external sources. PATHWAY: THERAPEUTIC SERVICES (HL THR) 9.3.HL THR.1 Utilize communication strategies to answer patient/client questions and concerns on planned procedures and goals. 9.3.HL THR.2 Communicate patient/client information among healthcare team members to facilitate a team approach to patient care. 9.3.HL THR.3 Utilize processes for assessing, monitoring and reporting patient’s/clients’ health status to the treatment team within protocol and scope of practice. 9.3.HL THR.4 Evaluate patient/client needs, strengths and problems in order to determine if treatment goals are being met.

English Language Arts Standards/ Literacy in Science and Technical Subjects/ Grades 11-12. Key Ideas and Details: CCSS.ELA - LITERACY.RST.11 - 12.1 Cite specific textual evidence to support analysis of science and technical texts, attending to important distinctions the author makes and to any gaps or inconsistencies in the account. CCSS.ELA - LITERACY.RST.11 - 12.2 Determine the central ideas or conclusions of a text; summarize complex concepts, processes, or information presented in a text by paraphrasing them in simpler but still accurate terms. Craft and Structure: CCSS.ELA - LITERACY.RST.11 - 12.4 Determine the meaning of symbols, key terms, and other domain-specific words and phrases as they are used in a specific scientific or technical context relevant to grades 11-12 texts and topics. CCSS.ELA - LITERACY.RST.11 - 12.5 Analyze how the text structures information or ideas into categories or hierarchies, demonstrating understanding of the information or ideas. CCSS.ELA - LITERACY.RST.11 - 12.6 Analyze the author's purpose in providing an explanation, describing a procedure, or discussing an experiment in a text, identifying important issues that remain unresolved. Integration of Knowledge and Ideas: CCSS.ELA - LITERACY.RST.11 - 12.7 Integrate and evaluate multiple sources of information presented in diverse formats and media (e.g., quantitative data, video, multimedia) in order to address a question or solve a problem. CCSS.ELA - LITERACY.RST.11 - 12.8 Evaluate the hypotheses, data, analysis, and conclusions in a science or technical text, verifying the data when possible and corroborating or challenging conclusions with other sources of information. CCSS.ELA - LITERACY.RST.11 - 12.9 Synthesize information from a range of sources (e.g., texts, experiments, simulations) into a coherent understanding of a process, phenomenon, or concept, resolving conflicting information when possible. Range of Reading and Level of Text Complexity: CCSS.ELA - LITERACY.RST.11 - 12.10 By the end of grade 12, read and comprehend science/technical texts in the grades 11-CCR text complexity band independently and proficiently.

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English Language Arts Standards / Writing for History/Social Studies, Science and Technology/ Grade 11-12

Text Types and Purposes: CCSS.ELA - LITERACY.WHST.11 - 12.1 Write arguments focused on discipline-specific content. CCSS.ELA - LITERACY.WHST.11 - 12.1.D Establish and maintain a formal style and objective tone while attending to the norms and conventions of the discipline in which they are writing. CCSS.ELA - LITERACY.WHST.11 - 12.2 Write informative/explanatory texts, including the narration of historical events, scientific procedures/experiments, or technical processes. CCSS.ELA - LITERACY.WHST.11 - 12.2.A Introduce a topic and organize complex ideas, concepts, and information so that each new element builds on that which precedes it to create a unified whole; include formatting (e.g., headings), graphics (e.g., figures, tables), and multimedia when useful to aiding comprehension. CCSS.ELA - LITERACY.WHST.11 - 12.2.B Develop the topic thoroughly by selecting the most significant and relevant facts, extended definitions, concrete details, quotations, or other information and examples appropriate to the audience's knowledge of the topic. CCSS.ELA - LITERACY.WHST.11 - 12.2.C Use varied transitions and sentence structures to link the major sections of the text, create cohesion, and clarify the relationships among complex ideas and concepts. CCSS.ELA - LITERACY.WHST.11 - 12.2.D Use precise language, domain-specific vocabulary and techniques such as metaphor, simile, and analogy to manage the complexity of the topic; convey a knowledgeable stance in a style that responds to the discipline and context as well as to the expertise of likely readers. CCSS.ELA - LITERACY.WHST.11 - 12.2.E Provide a concluding statement or section that follows from and supports the information or explanation provided (e.g., articulating implications or the significance of the topic). Production and Distribution of Writing: CCSS.ELA - LITERACY.WHST.11 - 12.4 Produce clear and coherent writing in which the development, organization, and style are appropriate to task, purpose, and audience. CCSS.ELA - LITERACY.WHST.11 - 12.5 Develop and strengthen writing as needed by planning, revising, editing, rewriting, or trying a new approach, focusing on addressing what is most significant for a specific purpose and audience. CCSS.ELA - LITERACY.WHST.11 - 12.6 Use technology, including the Internet, to produce, publish, and update individual or shared writing products in response to ongoing feedback, including new arguments or information. Research to Build and Present Knowledge: CCSS.ELA - LITERACY.WHST.11 - 12.7 Conduct short as well as more sustained research projects to answer a question (including a self-generated question) or solve a problem; narrow or broaden the inquiry when appropriate; synthesize multiple sources on the subject, demonstrating understanding of the subject under investigation. CCSS.ELA - LITERACY.WHST.11 - 12.8 Gather relevant information from multiple authoritative print and digital sources, using advanced searches effectively; assess the strengths and limitations of each source in terms of the specific task, purpose, and audience; integrate information into the text selectively to maintain the flow of ideas, avoiding plagiarism and overreliance on any one source and following a standard format for citation. CCSS.ELA - LITERACY.WHST.11 - 12.9 Draw evidence from informational texts to support analysis, reflection, and research.

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