Month XX, XXXX - Rutgers School of Health Related...

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Biopharma Educational Initiative Rutgers, The State University of New Jersey 65 Bergen Street, Room 171 Newark, NJ 07101-17 MS in Clinical Trial Sciences An Industry and University shrp.rutgers.edu/dept/ biopharma/index.html [email protected] p. 973-972-6482/8444 f. 973-972-7228 Course: BPHE7610P Capstone Course Department: Department of Health Informatics, MS in Clinical Trial Sciences Course Description: This Capstone course provides an opportunity for students to integrate knowledge and skills acquired throughout the MS in Clinical Trial Sciences program in a practice setting involving drug development. With their MS track advisor’s approval; students may select a research, educational, clinical, managerial, or service-related experience. The course will be individualized based on identified goals, competencies, and the student’s specialization track. Students may choose from one of the following activities: Option 1. Mentored Field Work experience: students gain work experience in their fields of academic study at an outside academic medical center, research site, pharmaceutical company, or contract research organization, OR at their place of employment that utilizes skills and knowledge acquired in the program, but not part of the student’s job description. Examples include: Perform study coordinator job role activities at a clinical research site. Perform functions of a job role outside their current department within their place of employment. Option 2. Mentored Graduate Project experience: students research a particular topic and prepare a white paper or other deliverable (webinar, abstract and poster) that is of value to an outside academic medical center, research site, pharmaceutical company, or contract research organization, OR Rutgers, The State University of New Jersey 12/14 Health Informatics Rutgers, The State University of New Jersey 65 Bergen Street, Room 171 Newark, NJ 07101-1709 MS in Clinical Trial Sciences An Industry and University shrp.rutgers.edu/dept/ biopharma/index.html [email protected] p. 973-972-6482/8444 f. 973-972-7228 1

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

p. 973-972-6482/8444f. 973-972-7228

Course: BPHE7610P Capstone Course

Department: Department of Health Informatics, MS in Clinical Trial Sciences

Course Description:This Capstone course provides an opportunity for students to integrate knowledge and skills acquired throughout the MS in Clinical Trial Sciences program in a practice setting involving drug development. With their MS track advisor’s approval; students may select a research, educational, clinical, managerial, or service-related experience. The course will be individualized based on identified goals, competencies, and the student’s specialization track.

Students may choose from one of the following activities:

Option 1. Mentored Field Work experience: students gain work experience in their fields of academic study

at an outside academic medical center, research site, pharmaceutical company, or contract research organization, OR

at their place of employment that utilizes skills and knowledge acquired in the program, but not part of the student’s job description.

Examples include: Perform study coordinator job role activities at a clinical research site. Perform functions of a job role outside their current department within their place of employment.

Option 2. Mentored Graduate Project experience: students research a particular topic and prepare a white paper or other deliverable (webinar, abstract and poster) that is of value to

an outside academic medical center, research site, pharmaceutical company, or contract research organization, OR

at their place of employment that utilizes skills & knowledge acquired in the program, but not part of the student’s job description.

Examples include: Produce a white paper on a topic of interest to a professional scientific organization, such as the Drug Information Association (DIA). Lead a process improvement project within their current company.

Option 3. Inquiry-based paper under the guidance of faculty: This choice is reserved for students who demonstrate poor performance (earned below a “C”) on their mentored fieldwork experience. If this should occur, the student will not be offered an outside experience when the course is repeated and instead must write a review article on a topic related to their course of study under the advisement of a faculty member. The manuscript should be in journal format and submitted for publication.

Under certain circumstances the student may choose this option initially if their interest is closely aligned with a faculty members.

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Health InformaticsRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-1709 MS in Clinical Trial Sciences An Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

p. 973-972-6482/8444f. 973-972-7228

Option 4. Write a systematic review in IDST6400 Evidence Based Literature Review. This option is available to students who wish to learn how to conduct a systematic review and develop an understanding of a meta-analyses and evidence based literature review. This option is available in the Fall and Spring semesters only. This course will replace BPHE7610 Capstone Course.

Final deliverables must be approved by the Capstone Course Faculty Advisor, and include the following:

Project Plan Research Paper OR written manuscript for publication in journal-ready format AND/OR

Oral Presentation OR an Abstract and Poster Presentation submitted to a Conference

Credits/Mode of Instruction:3 credits

This course utilizes a Moodle Platform to facilitate communication between students and the course instructor and Capstone Course Faculty Advisors.

Prerequisites:Core courses for the MS degree plus all individual courses that are required in the student’s specialty track.

Students must begin to identify their proposed Option no later than one semester prior to starting this course. There is administrative paperwork that students must fill out, as well as, contracts that need final approval. Please reference Appendix A. All of this takes time, and if begun late, may substantially delay initiation of the course and graduation. In addition, there are only a limited number of fieldwork experiences available each semester and there is no guarantee of placement.

There must be an identified Preceptor who agrees to serve as a content advisor for the students deliverables and will be responsible for supervising his/her effort, as well as, for providing feedback on his/her performance to the student and Capstone Course Faculty Advisor.

If the student prefers a mentored fieldwork or graduate project experience at an outside location, they must have earned a grade of B or better in all courses up to one semester prior to starting the course and have not violated the Student Honor Code.

Instructor:Lisa Palladino Kim, MS, can be reached through the Course Management System e-mail built into the course (via Moodle email). Students may also contact Professor Kim via the phone at 973-972-1856 or by email [email protected]. All communication will be returned within 48-72 hours. Professor Kim will also perform the role of Graduate Course Coordinator.

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

p. 973-972-6482/8444f. 973-972-7228

Course Goals and Objective/Outcomes:

Goals: Intended to provide students with the opportunity to perform a prospectively planned research, educational, administrative, or community service activity that will enhance their ability to either apply their knowledge to real-life situations or to further their knowledge through in-depth research on a topic of interest.

Objectives/Outcomes:

Students will develop their own objectives and competencies in conjunction with their Preceptor based on their own specialty tracks and interests.

Upon completion of the Capstone Course, the student will have: Integrated and applied concepts, principles, and skills obtained through coursework to

an identified project or fieldwork experience. Evaluated or self-assessed performance on tasks identified by a preceptor and/or course

faculty advisor. Disseminated experiences and project in the form of either an oral presentation OR

poster presentation, and/or written paper OR manuscript for publication in journal-ready format.

Course Requirements:

1. Option Selection: Student must take the lead in identifying a project and/or location for this experience. Assistance will be provided by the Capstone Course Coordinator particularly in regards to establishing a contractual relationship with selected institution and in assisting with the writing of project/experience objectives. Contracts must be signed prior to beginning any course work.

2. In addition to having a Capstone Course Coordinator/Instructor, students will be assigned a Preceptor and a Course Faculty Advisor to provide guidance and input during the course.

3. Attendance and participation in all web sessions and discussions are required. This includes, but is not limited to, a midterm summary of experiences and discussions with other classmates in Moodle.

4. All students will be responsible for completing a Final Deliverable, to be determined by student in collaboration with the Course Faculty Advisor and Preceptor.

Role of the Capstone Course Coordinator, Course Faculty Advisor, Preceptor, and Student:

1. Capstone Course Coordinator/Instructor (Coordinator): Prior to the course: Work with the student to identify the fieldwork or graduate project

site, if applicable; facilitate course contract process and approve the objectives for the

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

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p. 973-972-6482/8444f. 973-972-7228

contract.

During the course: Discuss the student’s progress with the Preceptor and Course Faculty Advisor; provide feedback to the student throughout the process, when applicable; review final deliverable(s) and assist Course Faculty Advisor in grading; submit course grades. In addition, perform the Instructor role and manage the discussion/posting requirements on Moodle.

In addition, perform the Course Faculty Advisor role, if necessary.2. Course Faculty Advisor (Course Advisor):

During the course: Provides high level guidance on deliverables, addresses any conflicts or concerns that might arise, and discusses student progress. Course Advisor will grade the main deliverables and assist in scheduling an oral presentation on adobe (if selected as the appropriate forum) near the end of the semester. 

3. Preceptor: A point person assigned from the contracted outside institution or at the student’s current employment.

Prior to the course: Collaborate with the Student and Coordinator to generate fieldwork and/or graduate project objectives for the course contract.

During the course: Create a learning experience environment for the student by: guiding the student through the institution’s processes and providing specific content guidance around course deliverables. The Preceptor will provide feedback to the student at the midterm of the experience and at the end of the experience. The Preceptor will formerly evaluate the student using the student evaluation form, but informal feedback is expected weekly.

4. Student: Each student is responsible for the following: In collaboration with the Preceptor, obtain all relevant materials, e.g. policy manuals,

textbooks, course outlines, treatment manuals, or anything else required for the fieldwork or graduate project experience.

Adhering to all applicable policies and procedures (hours, schedules, security requirements, phone usage, behavior and dress codes, etc.) of the collaborating institution or agency.

Providing the Preceptor with a set schedule of the days/times he/she will be present and participating in project activities (attendance and punctuality are mandatory; if absence or lateness is unavoidable, the Preceptor must be contacted immediately).

Attending related classes, demonstrations, meetings or seminars related to their fieldwork or project role.

Submitting all developed materials, procedures, protocols, reports, etc. for review, revision and approval to the Preceptor, if applicable, and Course Advisor well in advance of any scheduled meetings or presentations.

Developing a product(s) (Final Deliverable(s)). Where possible, the product should be of value to both the collaborating institution and the student.

Submit all required Waiver forms, self-assessment and site evaluation.

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

p. 973-972-6482/8444f. 973-972-7228

Rehearsing for Oral Presentation if applicable: This is not required but highly recommended.

Evaluation/Assessment:Below is the MS in Clinical Trials grading scale found on the Biopharma website under Grading Policy. Please review the policy and note that students must have a minimum GPA of 3.0 or above to graduate from the program. Grades for assignments, discussions, project plan, and student evaluation will be posted in the grade book.

A 90-100B+ 86 - 89B 80-85C+ 76-79C 70-75F below 70

Grading in this course is based on earning points with the maximum possible equal to 100.

Grading: Please also refer to the grading rubric in the Moodle course for more details.

Summary:The student will spend up to 270 hours completing the graduate project or field work experience.

Grading Summary Points AwardedProject Plan 20 pointsMid-semester summary 10 pointsDeliverable 50 pointsStudent Performance Evaluation 20 pointsTotal Project Points 100 points

Grade Details: 1. Project Plan (20 points)

Completion of the Project Plan and all related activities as specified in the Project Plan (timeliness, communication with points of contact, type of activities, goals and objectives)

2. Submit mid-semester summary regarding status of project plan. (10 points) Instructions found in Moodle

3. Key Deliverable(s). (50 points) Please refer to the grading rubric in the Moodle course for more details.

Deliverables are: Research Paper OR written manuscript for publication in journal ready format, and/or Oral Presentation OR an Abstract & Poster Presentation in summation to a conference ready format

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

p. 973-972-6482/8444f. 973-972-7228

Organization Subject knowledge Graphics Mechanics Elocution This includes only 2 rounds of draft deliverable(s) reviewed from Course Advisor.

4. Student Performance Evaluation-Appendix C (20 points) Student practice is consistent with professional guidelines Student practice is consistent with legal and ethical guidelines Competencies are at least at entry level

Late Policy:Students who are late to turn in assignments or discussions will be penalized 1 points per day for every day they are late unless prior arrangements have been made with the instructor or legitimate extenuating circumstances occur. The instructor reserves the right to request documentation on a case by case basis.

In Progress and Incomplete Grades: If the Capstone Course Coordinator and Course Faculty Advisor agree that due to reasons beyond the student’s control that the mentored fieldwork or project experience requires more than one semester to complete, the student will earn an In Progress (IP) grade at the end of the first semester. If a student does not complete the graduate course experience after two semesters due to reasons beyond the student’s control, the (IP) will revert to an Incomplete (I) and the student will have one year after receiving the Incomplete to complete the fieldwork or project experience. After the one year, the (I) will automatically revert to an (F) if the experience has not been completed.

Unsatisfactory Performance/ProgressStudents will receive a written warning if performance is unsatisfactory following the midpoint of the semester. The warning letter will be sent via the course e-mail. The student will also be counseled to meet with the instructor/preceptor/ advisor to determine a strategy for improving performance in the second half of the semester.

Course Failure:If a student fails a mentored fieldwork or graduate project experience, they will not be allowed to repeat it. The student will be assigned to a faculty member and complete an inquiry based or review article in journal format for publication.

Faculty/Student Honor Code:(Refer to your SHRP Student Handbook at http://shrp.rutgers.edu/current_students/pdf/Handbook.pdf The faculty of RBHS-Rutgers School of Health Related Professions believes that students must observe and support high standards of honesty and integrity in all aspects of education, practice, and research. For this reason, all students in this course are expected to abide by the School’s Faculty/Student Honor Code and accept responsibility to help ensure that these

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

p. 973-972-6482/8444f. 973-972-7228

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.

Students have the responsibility for personal and professional integrity and honesty in all academic activities. As future clinical research professionals, students must adhere to the high standards of professional and ethical conduct.

Computer Requirements:For hardware and software requirements and technology support see the following URL:http://shrp.rutgers.edu/tech4sure/student_services.htm

Computer requirements include the following: Screen resolution: Recommended: 1280 X 1024; Minimum: 1024 X 768 High-speed internet access Browser Requirements: See moodle homepage for up-to-date information on

browsers Headsets with a microphone will be needed for live audio conferencing sessions

Moodle Help: The student should contact the Moodle Support Staff at 973 972-8676, 9 AM – 7 PM or email [email protected]

Accommodations:Students are encouraged to discuss requests for accommodation with the Instructor/ Coordinator and Course Advisor.  Students requesting accommodations must also include a Student Services Counselor from SHRP’s Office of Student Services. This department will assist students with disabilities in reasonable accommodations. Students are encouraged to visit the OSS’s website: http://shrp.rutgers.edu/current_students/shrp_oss_home.html Information about supported education services is also available.

Required and Recommended Resources:Readings will be individualized and tailored by the Preceptor.

Course Evaluation:At the end of the course, students will be asked to evaluate the site and preceptor. Student feedback is valued and will be submitted anonymously. The evaluation will be posted in our course management system.

Course Schedule/Details:This schedule is a plan only and 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.

Prior to the Course:

1. At least one semester before student begins the Mentored Field Experience Course:

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

p. 973-972-6482/8444f. 973-972-7228

Fill out Appendix A Capstone Course Proposal Form to indicate which Option is of interest. Scan and email it to the Capstone Course Coordinator, Lisa Palladino Kim, at [email protected]

In collaboration with the Coordinator: Discuss possible placements and/or assist in the search for a placement location

or preceptor that meets the student interests. Complete contract requirements. Please note: Students cannot move forward

until contracts have been signed. Register for BPHE 7610, after contract is signed or as indicated by the

Coordinator. Depending on your course location, then:

At an outside company At current place of employmentComplete the CITI and HIPPA trainings and submit both certificates to the Coordinator and Preceptor.

http://rbhs.rutgers.edu/hsweb/education/ index.html

https://ethics.umdnj.edu/mtrxprod/ Ethics_Template/frontpage.cfm?goto=https://ethics.umdnj.edu/mtrxprod/Ethics_Apps/MATRIX/index.cfm

Arrange for Background Check, if required by Preceptor:

http://shrp.rutgers.edu/ prospective_students/admissions/CBC.html

Determine if an IRB application is necessary and if yes, complete eIRB tutorial

http://rbhs.rutgers.edu/hsweb/ eIRB/material.html

2. For outside company placements only, once contract has been signed but prior to starting course:

Submit proof of Health Insurance, if required by Preceptor Submit Health Immunizations, if required by Preceptor. Student will not be permitted to

begin course work until he/she have received clearance from the health department at the site or receive notice of compliance from Student Health.

Forms are located at:o http://shrp.rutgers.edu/prospective_students/admissions/

admissions5_immunization.htmlo http://shrp.rutgers.edu/prospective_students/admissions/documents/

WebImmunizationRecord.pdfo http://shrp.rutgers.edu/prospective_students/admissions/documents/

HISTORY_PHYSICAL_FINAL.pdf

3. Once semester begins, students will be expected to spend up to 270 hours at an institution.

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

p. 973-972-6482/8444f. 973-972-7228

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Week Student Assignments in addition to assignments provided by contracted institution. Details on Moodle supersede this document.

One

1. Review: Course documents including, but not limited to, grading rubric,

syllabus, requirements per deliverable Project Plan Overview

2. Draft: Start creating Project Plan (Appendix B), including how often student will meet regularly with Course Advisor and/or Preceptor and when final deliverables will be delivered.3. Post Discussion: Introduction, including placement location, contract objectives, and first week experiences.

4. For Students Who Are Performing a Project at Their Work Site, file with the IRB if required:

http://rbhs.rutgers.edu/hsweb/eIRB/help.html https://eirb.rutgers.edu/eIRB/Rooms/DisplayPages/LayoutInitial?

Container=com.webridge.entity.Entity[OID[AC482809EC03C442A46F2C8EEC4D75D3]]

Four

1. Review: Guidelines for oral/poster presentations and written paper/manuscript for publication2. Draft: Start creating deliverables Note: The Students specific deliverables will be approved by Course Advisor, in collaboration with Preceptor.

Six1. Submit: Final Project Plan for grading. Note: Course Advisor may provide feedback on a maximum of two draft versions prior to submitting for final grade.

Eight

1. Review: PPT slide announcement sample and instructions, inviting students and faculty to attend your oral presentation, if applicable.2. Schedule: If applicable, schedule your oral presentation, in collaboration with your course Advisor and/or Preceptor,.3. Submit: Prepare and submit mid-semester summary of activities in the Moodle drop down box; instructions found in Moodle course4. If applicable, fill out graduation forms (at least eight weeks prior to expected graduation date)

http://shrp.rutgers.edu/current_students/Forms/form.html

Ten

1. Disseminate: If applicable, fill out power point template slide announcing the presentation, and submit to the program assistant (Arlene Deas [email protected]) for distribution to faculty and students. Template can be downloaded from Moodle.

Twelve-Fourteen

1. Disseminate: Send solid draft of deliverables to Course Advisor and/or Preceptor for feedback.2. Continue: Enhance and finalize deliverables.3. Present: Present power point slide deck, if applicable.

Fifteen

1. Submit: Final deliverables for grading Completed Appendix C: Self Evaluation Completed Appendix D: Site (Preceptor) Evaluation Signed waivers as appropriate (copyright or waiver to share

project)2. Review outside of Moodle space:

Course Advisor will discuss with student the overall evaluation of the student (including Preceptor feedback)

Student will discuss with Course Coordinator overall evaluation of the course and experience

3. Students Who Are Performing a Project at Their Work Site: Close out

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-17

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This course material is copyrighted and all rights are reserved by Rutgers University. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any form or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the express prior written permission of Rutgers University.

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Appendix A: CAPSTONE COURSE PROPOSAL FORM

The Graduate Capstone Course and Evidence Based Literature Review courses are intended to provide students with the opportunity to perform a prospectively planned research, educational, administrative or community service activity that will enhance their ability to either apply their knowledge to real-life situations or to further their knowledge through in-depth research on a topic of interest. Students have three options for completing this requirement: 1. Research and write a scholarly paper with advisement from the faculty, 2. Perform a graduate project or fieldwork experience at their current place of employment or 3. Perform a graduate project or fieldwork experience at an outside academic medical center, research site, pharmaceutical company, or contract research organization.

The fieldwork option provides an opportunity for students to integrate knowledge and skills acquired throughout the program in a practice setting intricately involved in drug development. Experiences will be individualized based on identified goals and competencies, and the student’s specialization track. Assistance will be provided by the Capstone Course Coordinator with regards to establishing a contractual relationship with the site and assisting with the development of project objectives. However, students are expected to take an active role in identifying a company or entity near their place of residence. Since legal contracts need to be signed with the site prior to the first day of the experience, it is necessary for the students to begin identifying a site at least one semester in advance. In some cases a Criminal Background Check and additional immunizations will be needed. In addition, students are required to have a B or better in ALL previous coursework since entering the Clinical Trial Sciences Programs, even if courses have been repeated secondary to failed grade.

NAME: DATE:

A#: TRACK:

PREVIOUS DEGREES & MAJOR:

EXPECTED TERM & YEAR FOR CAPSTONE COURSE:

I can confirm my Rutgers Graduate Track advisor is in agreement with the timing of this course.

For students seeking to register for this graduate project course in the summer and who typically obtain financial aid for fall/spring, please confirm with us your plans in regard to financing prior to registering as summer is an optional term and not typically covered by financial aid.   Please select one:

I typically seek financial aid and I am aware of my options in the summer   I typically seek financial aid but I am unaware of the summer options          I do not typically seek financial aid   

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-1709

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shrp.rutgers.edu/dept/biopharma/index.html [email protected]

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EXPERIENCE REQUESTEDI plan on performing an in-depth research paper with a Faculty Advisor in the following area: For this option, the student will be asked to register for IDST6400 Evidence Based Literature Review (offered in the fall and spring semesters only)

I plan on performing a project or work experience at my place of employment under the guidance of a manager/supervisor, also known as the Preceptor. Please provide the name and contact information of the Preceptor.

I can confirm I have received a B or above on all previous Master of Science courses and would like a fieldwork experience in the following areas:

TIME PERIOD OF AVAILABILITY FOR FIELDWORK EXPERIENCE

Full days: which days

Morning only: which days

Afternoon only: which days

ABILITY to TRAVEL

Hometown:

Distance willing to travel:

HAVE YOU IDENTIFIED A SITE:Name and other Contact Information at site:

Please fill in this form and email to Professor Lisa P. Kim at [email protected] Rutgers, The State University of New Jersey

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CAPSTONE PROJECT WRITTEN PLAN(TO BE COMPLETED AND APPROVED PRIOR TO INITIATING THE PROJECT)

All of the following sections MUST be completed in detail BEFORE a student is permitted to begin the Capstone Project. Furthermore, your plan must be approved by your project advisor and your site preceptor (if applicable) BEFORE you are permitted to begin work on your project. Note: depending upon the specific graduate project, the components of the plan may be modified. However, modifications can only occur with permission of the advisor.

Cover Page (to include the following):

Proposed project title or position description and dates Name and address of project site (collaborating institution or agency) Student's name, phone number and e-mail address Preceptor’s name, title, phone and e-mail address Advisor’s name, title, phone and e-mail address Submission and approval signatures and dates if requested by advisor

 Rationale for Project OR paper:

Provide a concise rationale for conducting the project. Describe why the project site was selected. Explain any remuneration arrangements. 

Project Objectives(s): 

In clear, concise and measurable terms, state the expected outcome(s) of the project. List objectives in logical sequence when there is more than one to be accomplished. Justify each objective with a short rationale. Indicate how the project contributes to the student's program or career goals.

 Activities and Timelines:  (Provide realistic timelines in the event of delays)

Specify methods to be used to accomplish each objective. Indicate the target date for each major activity. List activities in chronological order. If the advisor indicates that the projects involves “research” or otherwise requires

Institutional Review Board (IRB) approval, then the activities and timelines should be reflective of this. Note that IRB submission and approval can take several months to obtain, and that the project cannot begin until such approval is confirmed.

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 Resources: 

Identify factors (human and non-human) that are required to properly complete the project.

Indicate the availability of the resources.

 Constraints:  

Identify factors that may hinder the accomplishment of each objective. Propose strategies to overcome any anticipated constraints. 

Communication/Presentation of Results:  

Indicate the way in which the results will be disseminated to those individuals involved or potentially interested in the project outcomes (e.g. advisor, preceptor, collaborating institution, other students, etc.). Where appropriate, students are encouraged to disseminate the results via a scholarly outcome such as a poster and/or manuscript submission.

An oral presentation and/or written paper are required. Under certain circumstances a poster presentation submission to a conference may substitute for the written paper. The type of presentation is to be determined in collaboration with the student’s advisor.

Evaluation: 

Specify what evidence will be used to demonstrate completion of the project. Indicate criteria to be used for the evaluation of the project outcomes. Conduct a self-evaluation of the project process and final product.

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-1709

MS in Clinical Trial SciencesAn Industry and University Collaboration

shrp.rutgers.edu/dept/biopharma/index.html [email protected]

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Appendix C Self-Assessment

NAME:

Please answer either Always, Frequently, Some of the Time, Seldom, Never

1. Sought personal excellence:

Always Frequently Some of the time Seldom Never

2. Self-directed and productive:

Always Frequently Some of the time Seldom Never

3. Expanded personal knowledge

Always Frequently Some of the time Seldom Never

4. Took full advantage of the learning opportunities

Always Frequently Some of the time Seldom Never

5. Demonstrated Professional Behavior

Always Frequently Some of the time Seldom Never

6. How happy are you with the final product? Please explain

7. What helped or hindered your progress?

8. If you had this experience again, what would you change in terms of your performance?

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MS in Clinical Trial SciencesAn Industry and University Collaboration

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Appendix D Site Evaluation

Student Name:___________________________________________

Specialization Track: ______________________________________

Name of Fieldwork Site: _____________________________________

Address:____________________________________________________________________________

Mentor’s Name: ____________________________________________

I. Type of Experience:

II. Orientation:

1. Did you receive information from the facility prior to your arrival ____ Yes ____No

2. Did you receive an on-site orientation ____Yes____No

3. What else could have been provided during the orientation?

III. Experience:

1. Was this experience conducive to your growth as an emerging professional ____Yes ____No

2. List your specific duties.

3. What suggestions could you offer to improve the experience?

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MS in Clinical Trial SciencesAn Industry and University Collaboration

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4. Describe any special learning experiences you encounter.

5. Discuss any logistical details associated with this experience that may be helpful to students in the future, such as parking, costs, etc.

IV. Assessment of Instruction

1. Did the Mentor facilitate good communication?

2. Was the Mentor available to answer any questions?

3. Did the Mentor provide constructive feedback on your performance?

4. Did the Mentor add to your learning experience?

V. Overall Summary

1. Overall, how would you rate this experience: check one

_____Excellent _____Good _____Fair _____would not recommend

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Biopharma Educational InitiativeRutgers, The State University of New Jersey65 Bergen Street, Room 171Newark, NJ 07101-1709

MS in Clinical Trial SciencesAn Industry and University Collaboration

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APPENDIX EPreceptor/Advisor Evaluation of Student:

Student: __________________

Dates of Experience:________________________

Company/Organization if applicable: __________________________________________

Address/Contact Information: _______________________________________

_______________________________________________________________

Company Supervisor/contact Information: _____________________________

________________________________________________________________

Domain Criteria

1

Unacceptable

2

Needs Improvement

4

Exemplary

Points

earned

Timeliness Missed 20% or more of meetings; significant delay in meeting deadlines

Missed /late for 10% of meetings; missed deadlines by few days to one week

On time for all meetings with advisor/preceptor

All deadlines met based on project plan

Manages Communication & Contacts

Ignores communication from Preceptor/Advisor

Responds to queries from Preceptor/Advisor by one week

Exhibits timely response to all emails and communication from preceptor; contacts advisor to inform of any unforeseen illness or anticipated tardiness

Respect & collegiality

Ignores suggestions made by Preceptor/Advisor

Somewhat receptive to suggestions made by Preceptor/Advisor but with push back; adjusts deliverables superficially

Receptive to suggestions & feedback and adjusts deliverables accordingly, or if not, discusses differences in a collegial manner

Self-Initiative Rarely takes initiative Occasionally takes initiative in planning & carrying out the project

Almost always takes initiative in planning & carrying out the project

Strives for a high level product

Accepts mediocre work Makes an effort to produce above average work

Strives for Excellence

Total

Adapted from Rubric for Assessing Professional Development

www.uvm.edu/~socwork/msw/pdfs/Rubric.pdf

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