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Curriculum For Master's Degree**

Core:

Course Code Course Title* Credit Instructor Term Offered
BPHE 5310P Clinical Trials Overview: Methods & Practice 3 cr

N Jose

Fall & Spring

BPHE 5521P Regulatory & Ethical Requirements in Clinical Investigations 3 cr

P Beers Block

Fall & Spring

BPHE 7610P

Capstone Course (Mentored Fieldwork)** or
IDST 6400 Evidence Based Literature Review or
BPHE 7620 Scientific Writing for the Translation of Medicine

3 cr

L Palladino Kim S Parrott
DW Lechner/ B Tafuto

Fall & Spring

Specialization Tracks:

Clinical Trials Management & Recruitment Sciences Track

BINF 5075E Biomedical Informatics for Clinical Trials Management 3 cr

S Srinivasan

Spring

BPHE 5500P

Multiple Analyses in Clinical Trials or
IDST 6121 Data Interpretation (pre-req for IDST 6400)

3 cr

TBD
S Parrott

Summer
Fall & Spring

BPHE 5510P Overview of Disease Processes and Treatment 3 cr

R Keller

Fall

BPHE 6352P Applied Clinical Trials & GCP 3 cr

P Jester

Spring

BPHE 6510P Clinical Operations 3 cr

L Palladino Kim

Fall

BPHE 6985P Principles of Subject Recruitment and Retention 3 cr

L Palladino Kim

Spring

Regulatory Affairs Track

BPHE 5500P

Multiple Analyses in Clinical Trials 

or IDST 6121 Data Interpretation (pre-req for IDST 6400)

3 cr

TBD

S Parrott

Summer

Fall & Spring

BPHE 5725P

Adverse Event Reporting & Postmarketing Activities

3 cr

J Buckley

Fall & Spring

BPHE 6200P

Concepts of GxPs & Quality Assurance

3 cr

T Lee

Spring

BPHE 6500P

Regulatory Requirements for Medical Devices

3 cr

W Ballesteros

Fall

BPHE 6530P

International Regulatory Affairs

3 cr

M Tice

Fall

BPHE 6800P

Regulatory Writing for Submission & Publication

3 cr

P Beers Block

Spring

Drug Safety & Pharmacovigilance Track*

BPHE 5500P

Multiple Analyses in Clinical Trials 

or IDST 6121 Data Interpretation (pre-req for IDST 6400)

3 cr

TBD

 

S Parrott

Summer

Fall & Spring

BPHE 5510P

Overview of Disease Processes and Treatment

3 cr

R Keller

Fall

BPHE 5725P

Adverse Event Reporting & Postmarketing Activities

3 cr

J Buckley

Fall & Spring

BPHE 5780P

Principles of Pharmacovigilance: Regulations & Drug Safety Reporting

3 cr

J Buckley

Spring

BPHE 6000P

Risk Management Tools

3 cr

S Tepper

Fall

EPID 0672

Pharmacoepidemiology and Therapeutic Risk Management

3 cr

Y Moride

Fall

BPHE 6720

Signal Detection & Quantifying Risk

3 cr

S Tepper / R Landau

Fall

BPHE 7510P

Clinical Pharmacology

3 cr

N Jose

Spring

*a clinical background and an understanding of pathophysiology is preferred if the student desires a position as a Drug Safety Officer. However there are individuals who may fill positions in drug safety departments who are involved with data collection and report writing, and do not necessarily require past clinical experience.

Medical Affairs Track

BPHE 5510P

Overview of Disease Processes and Treatment

3 cr

R Keller

Fall

BPHE 6352P

Applied Clinical Trials & GCP

3 cr

P Jester

Spring

BPHE 6530P

International Regulatory Affairs

3 cr

M Tice

Fall

BPHE 7620

Scientific Writing for Translation of Medicine

3 cr

D Lechner/B Tafuto

Fall & Spring

BPHE 6600P

Advertising & Labeling in Pharmaceutical Medicine

3 cr

P Beers Block/R Patel/L Cooper

Summer

BPHE 6700P

Special Topics in Clinical Trial Sciences

3 cr

N Jose

Spring

BPHE 6610

Strategy,  Insight Generation and Patient Journey

3 cr

N Jose/ T Suto/S Danandjaja

Summer

BPHE 6620

The Practice of Medical Affairs

3 cr

N Jose/ T Suto/S Danandjaja

Summer(starting 2019)

Approved Program Electives

Courses from any of the specialization tracks may also be taken as electives.

BPHE 5110P

Food & Drug Law

3 cr

C Asakiewicz

Summer

BPHE 5750

Six Sigma Methodology

3 cr

S Hudgins

Summer

BPHE 6600P

Advertising & Labeling in Pharmaceutical Medicine

3 cr

P Beers Block/R Patel/L Cooper

Summer

BPHE 6700P

Special Topics in Clinical Trial Sciences

3 cr

N Jose

Spring

BPHE 6830P

Project Management for the Life Sciences Professional

3 cr

L Palladino Kim

Summer

BPHE 7600P

Analyzing Clinical Data to Determine Adverse Events

3 cr

TBD

Summer(not offered 2018)

BINF 5100

Introduction Biomedical Informatics

3 cr

K Kirk

Fall & Spring

BINF 5403

Health Information Systems Design

3 cr

D Mital

Fall

IDST 5110E

Health Services, Issues, & Trends

3 cr

A Tucker

Spring

IDST 5200E

Principles of Transcultural Health Care

3 cr

R Eubanks

Fall

IDST 5215E

Human Resources Management

3 cr

A Heuer

Fall

IDST 5600E

Management & Leadership in Health Care

3 cr

J Reid Hector

Summer & Fall

IDST 6120E

Health Care Policy & Planning

3 cr

M Kilduff

Summer

NUTR 6505E

Ethical Issues in Health Care Practice

3 cr

D Gibson

Spring (not offered until 2020)

IDST 5700

Legal Aspects of Healthcare Administration

3 cr

A Heuer

Spring

NUTR 7510

Nutrition and Pharmacology

3 cr

J Ziegler

Spring

*Course  information including course description, goals, objectives, pre-requisites and textbook information is located athttps://apps.shp.rutgers.edu/projects/courseCatalog/coursecatalog.cfm ;select Degree: MS and Program: Clinical Trial Sciences and click on the RG link for the list of courses and click on the course number for access to the course information.

**Description for Capstone Course

The course is self-directed study producing a prospectively planned and approved health-care related/Pharmaceutical research, educational, clinical, administrative, or community service project designed to support and enhance the student's ability to apply their graduate experience. Students enrolled in the MS in Clinical Trial Sciences who are currently employed in the pharmaceutical industry can conduct their project at their place of employment. Students who are not working and new to the industry may have the option to perform a mentored fieldwork experience, if available. To be eligible, students must have earned a "B" or better in ALL courses up to one semester prior to starting the Capstone course, even if the course has been repeated for a higher grade. In addition, students must have demonstated   demonstrated high ethical standards in their course work. Students who have breeched   breached the Honor Code, Academic Integrity, or displayed any other “Acts of Misconduct” will also not be eligible for fieldwork. In some cases a Criminal Background Check, insurance information, and additional immunizations will be needed.

Students receiving financial aid must take at least 6 credits to qualify for aid in any given term.  Therefore students may wish to save one of their electives to take in conjunction with this 3 credit course. Students must take the lead in identifying a project for this experience but will be assigned a faculty advisor who wil  will work closely with them. Arrangements for this course need to be made at least one semester in advance, since some of the projects will require signing of legal documents which take time. Mentored experiences are available with the US Food & Drug Administration however some projects may exceed 3 credits.  Students interested in this experience will need to save their elective credits until close to the end of their program and apply them to the Capstone course.  Additionally students may need to relocate to Silver Springs Maryland if there are no remote experiences available at the time. Students will be responsible for their living expenses.

Prerequisites:    Core courses for the MS degree plus the majority of individual courses that are required in the student’s specialty track (approximately 21 specialty track credits).

Master's students apply here  online

**Please note, this list represents the most current version of the curriculum.  Enrolled Students should follow the Program Requirments for Graduation signed at the time of acceptance.

 

 

 

 

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