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Clinical Investigation

Welcome from the Coordinating Committee

About the Program

Master of Arts

Courses

 

 

 

Master of Arts in
Clinical Investigation Program


Coordinating Committee

Carl Franzblau, PhD
Thomas Moore, MD


Program of Study

The Master of Arts in Clinical Investigation is a rigorous program that meets the needs of health professionals engaged in the full-spectrum of patient-oriented research.  This flexible degree program is designed for a variety of professionals including physicians who will plan and oversee translational research and clinical trials; research nurses;  study coordinators; managers in clincial research and site management organizations (CROs and SROs); and professionals in the pharmaceutical, biotechnology and medical device industries.

The Program consists of:

A minimum of thirty-two credits

(25-26 credits are course courses;6-7 credits are elective courses)

Clinical Investigation Practicum
Thesis

Application

All applicants for admission to the Master of Arts in Clinical Investigation are required to:

  • Submit the results of the Medical College Admissions Test (MCAT) or the Graduate Record Examination (GRE) General Test.
 
  • Have met the requirements for the baccalaureate degree including the following courses:

General Chemistry

Organic Chemistry

Biochemistry

Biology

Physiology

Physics

Please note: Courses in English Composition or Literature (one year) and Humanities (one year) are recommended for admission to the M.A. in Clinical Investigation Program.

  • Applicants whose native language is not English are required to submit results no lower than 550 of the Test of English as a Foreign Language (TOEFL).

Admission Criteria

The overall grade point average (GPA) for acceptance is at least 3.0 with a higher average for the prerequisite sciences.

The average standardized test scores for acceptance are: MCAT scores of 25-30 for the verbal reasoning, biological and physical science tests and “O” for the writing sample; for the GRE, placement in the 70th percentile or above.

Degree Requirements

Master of Arts in Clinical Investigation candidates are required to complete all of the following:

A.   Curriculum

The equivalent of a minimum of eight semester courses equaling at least 32 credits at the graduate level. These must include the following requirements:

GMS CI 670 Biostatistics with Computer, 4 cr.

SPH EB 711 or SPH EB 712 Epidemiology, 3 or 4 cr.

GMS CI 640 Regulatory and Compliance Issues, 4 cr.

GMS CI 675 Design and Conduct of Clinical Trials, 4 cr.

GMS CI 660 Good Clinical Practices, 4 cr.

GMS CI 631 Clinical Trials Management, 4 cr.

GMS CI 790 Seminar in Clinical Investigation, 2 cr.

Total Core Course Credits = 25-26 credits

Students who have completed one or more of the required courses before matriculation may acquire "advanced standing" for that requirement. "Advanced standing" means that the student may waive the requirement but would need to replace the course requirement by taking an elective course(s). The student would not need to retake the course requirement. To waive a course requirement, students must speak to their academic advisor and complete/submit a "Petition for Approval of Advanced Standing."  No transfer credits from other BosU departments or institutions will be accepted.

The remaining 6-7 credits are taken as elective courses

A wide variety of courses in the Division of Graduate Medical Sciences that will count toward elective credit. At least two credits must be taken as an elective course. A maximum of eight credits or two semester courses may be taken as practicum and/or directed study. It is always best to have electives approved by your academic advisor before registering for them.

B.   Practicum

Completion of a minimum of 240 hours of a practicum in clinical trials is required for the degree. The practicum should begin near completion of formal coursework and the student needs to meet with the program director to get practicum approval before he/she begins.

The goal of the practicum direct experience component is to provide the student hands-on exposure to clinical research. The student will work with a mentor and will be actively involved in the development, execution, and evaluation of a clinical research project. During the practicum, it is expected that the student will be exposed to clinical research planning, protocol preparation, interaction with Institutional Review Boards, regulatory requirements, selection of subjects/patients for the clinical trial, study monitoring, and data analysis.

The practicum may be completed with a mentor who is actively conducting clinical research studies within a clinical research or hospital setting. It may be performed under the direction of a clinical research professional within a drug, device, or biotechnology company, a clinical research organization (CRO), or site management organization actively involved in clinical trials. Areas within Boston University School of Medicine that may offer practicum opportunities include Dermatology, Cardiology, Pulmonary, Urology, the General Clinical Research Center and the Goldman School of Dental Medicine.

C.   Thesis

A thesis, also required for the degree, will be based on the experience in the practicum.

The goal of the thesis component is for the student to write about the practicum direct experience. The thesis may take the form of a sample Physician's Investigational New Drug Application (IND) or a sample Physician's Investigational Device Exemption (IDE) for the drug or device under investigation. The thesis could also be a clinical report describing such study components as its objectives, design, protocol deviations, analysis and results, and conclusions. Each thesis is expected to demonstrate the student's understanding of the clinical research process from both a theoretical and a practical point of view. The thesis outline must be pre-approved by the mentor and the program director. A "Thesis Title Approval Card" must be submitted to the Division of Graduate Medical Sciences Office.

There will be two readers for the thesis; the first reader will be a Graduate Medical Sciences faculty member and the second reader may be a faculty member or an appropriate industry mentor upon approval of a "Special Service" appointment. The research project must be well conceived and well focused and the written thesis should be of modest scope.

A thesis committee will be organized to hear the oral thesis defense. The committee will consist of the two readers, one member of the Graduate Medical Sciences faculty, chosen by Drs. Moore and Franzblau and one member suggested by the student and approved by the program director. The student will give an oral presentation on the thesis highlights and be questioned afterwards by his/her thesis committee members in private.

 

 
   

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