The Master of Arts in Clinical Investigation (MACI) 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 clinical research and site management organizations (CROs and SROs); and professionals in the pharmaceutical, biotechnology and medical device industries.

The program consists of 3 components:

• Minimum of 32 graduate credits—18 required and 14 elective
• Clinical investigation practicum— Hands-on involvement in a clinical research project
• Thesis—Written research paper about the practicum

Degree Requirements

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

A minimum of 8 semester courses equaling at least 32 credits at the graduate level. These must include the following 18 credits in coursework:

• GMS CI 675 Designing Clinical Research Studies 4 cr
• GMS CI 631 Clinical Trials Conduct and Management 4 cr
• GMS CI 670 Biostatistics with Computer 4 cr
• GMS CI 640 Regulatory and Compliance Issues 4 cr
• GMS CI 790 Seminar in Clinical Investigation 2 cr

A minimum of 14 credits in elective coursework: A wide variety of courses offered in the Division of Graduate Medical Sciences will count toward elective credit. A minimum of 14 credits must be taken as electives, directed study or practicum. Up to 4 credits may be taken as the practicum. Please ensure that your electives are approved by your academic advisor before registering for them.

Please note: 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 BU departments or institutions will be accepted.

Practicum

Completion of a minimum of 240 hours of a practicum in clinical trials is required for the degree. The practicum usually begins near completion of formal coursework. The student is required to meet with the program director or assistant director to receive 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 also 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 (SMO) actively involved in clinical trials. Areas within Boston University School of Medicine that may offer practicum opportunities include Dermatology, Cardiology, Pulmonary, Psychiatry, the General Clinical Research Center, and the Goldman School of Dental Medicine.

**It is the responsibility of the student to identify/select a practicum site. The Assistant Director will assist in this process, but it is ultimately the student’s responsibility to ensure that a practicum mentor and site is selected on a timely basis.

At the completion of the practicum, the student will write a one to three page summary of activities accomplished during the practicum. This description will be reviewed by the mentor, signed that both agree that the practicum was successfully completed, and then submitted to the MACI Director as documentation of objectives achieved.

Thesis

Students in the MACI program are required to complete a research thesis that provides a culminating experience and applies the principles and methods learned in the coursework to a real-life clinical study.

The goal of the thesis component is to demonstrate the student’s understanding of the clinical research process from both a theoretical and a practical point of view. Students conduct their thesis research in wide variety of settings, including academic medical centers and local drug or device companies.

Students generally identify their research mentor and develop their thesis proposal while they are completing their course work or practicum. The thesis research must involve the analysis and interpretation of data. Students are encouraged but are not required to conduct primary data collection. The thesis proposal, research mentors and thesis readers must be approved by MACI Program Director Dr. Fish.

Thesis Readers: Each student must select at least 2 readers for their thesis. One of the readers must be a subject expert. If either of the readers are not faculty within the GMS Division, a Special Appointment Form must be completed and submitted to the GMS Office, along with the reader’s CV, for approval. PLEASE NOTE: A Special Appointment Form must be completed for each non-GMS Faculty reader. The research mentor cannot be a reader.

Note: Readers Outside of BU: If one of the readers is not faculty at BU, they must be assigned as a second reader and the Special Appointment requirements apply.

The research project must be well conceived and well focused. The written thesis should be of modest scope and should meet the current standards of publication in referred journals. The completed thesis must be approved by the thesis readers, at least one of whom is considered an expert in the field of research. Once the final draft is approved by the readers, the student gives a short oral presentation on the thesis research to the thesis readers, research mentor, MACI students and faculty members, and any other interested parties. The purpose of the oral presentation is to demonstrate the student’s ability (1) to describe clearly the thesis research question, methods, and results, (2) to demonstrate his/her understanding of study design and analytic principles and methods, and (3) to place his/her research into a clinical context. The presentation is followed by a question and answer period.

Additional Information

Students are required to abide by the rules and regulations of the Division of Graduate Medical Sciences:

Credit toward a degree will only be obtained from a passing grade (A to B-).

Grades of I and C+ or lower are interpreted as failures. A student receiving such grades in a total of 8 credit hours is terminated. A student receiving a failing grade will not be permitted to take a make-up examination.

A degree candidate, after completing all departmental course requirements, must register each regular semester as a continuing student and pay the continuing student fee until all remaining degree requirements are completed.

Please visit the Division of Graduate Medical Sciences website catalog at www.bumc.bu.edu/gms to view detailed administrative policies and procedures.

Study Options

The MACI program can be completed on either a part-time or full-time basis depending on your goal.

Most of the courses take place in the late afternoons or early evenings to account for those who work during the day.

Full-Time

The program is designed so that a full-time student completes his/her coursework in 3 semesters. Practicum and thesis components of the program should begin near completion of the coursework and the time frame for finishing them will be determined on a student-by-student basis by the program director or assistant director.

A full-time student is enrolled in 12–18 credits per academic semester (Fall and Spring). The full-time tuition for the 2010–2011 academic year is $39,314/year ($19,657/semester).

Part-Time

Part-time students must register for at least 4 but not more than 11 credits each academic semester until all course requirements are fulfilled. The part-time tuition for the 2010–2011 academic year (Fall and Spring) is $1,228 per credit.

Continuing Student

Students who have completed all departmental course requirements (32 credits) must register each subsequent semester as continuing students until all requirements for the degree have been completed. The Full- and Part-time Continuing Student fee: $2,456 per semester.

Non-Degree Option

A number of individuals who are uncertain as to whether they want to enroll in the program have the option of taking a few of the MACI courses as a non-degree student, and may then make their decision about completing the MACI application process. We allow the transfer toward the MACI degree of up to 2 MACI courses taken as a non-degree student. Applicants must submit a copy of the Application for Admission, indicating the specific objectives of the studies/courses sought. In addition, the applicant must submit (with the application) the nonrefundable application fee.

Non-degree costs: $1228 per credit; plus a $40 registration fee; plus a $10 program fee; plus a $50 application fee.

Please contact Natasha Hall at 617-638-5217 or at tashah@bu.edu for more information on the non-degree application process.

Nondegree applicants are not eligible for University sources of financial aid or aid that requires matriculation in a degree program.

Boston University School of Medicine currently supports two successful programs under the Division of Graduate Medical Sciences: the Master of Arts in Medical Sciences and Master of Arts in Clinical Investigation Programs. A review of curricula, student interests and goals, emerging careers for professionals with a background in the medical sciences, and clinical research suggested the need for a Master of Arts in Medical Sciences and Clinical Investigation Dual Degree Program. This program is now available to incoming students beginning in the Fall 2010.

A number of the students in the Medical Sciences Program who take the Clinical Investigation electives in that concentration do so to gain a clinical research background prior to attending medical school. Some students elect to pursue a MA in Medical Sciences and an MA in Clinical Investigation with the intent of pursing clinical research related career opportunities in academic institutions, or in pharmaceutical, biotechnology, or medical device industries. The dual degree option would give these students an opportunity to gain training that will serve them well as clinician- researcher.

Curriculum

The 50-credit Dual Degree Program in Medical Science and Clinical Investigation offers complementary curricula with a strong background in the medical sciences and research design and implementation. The model curriculum for the dual degree program (below) can be modified to meet specific student needs.

This unique program includes curricula in medical sciences and all of the key elements in clinical investigation offered in a dynamic hospital and medical school environment. The Program is designed as a two-year full-time experience although accommodations can be made for students who need more time to complete the dual degree. Senior faculty with clinical and research expertise will both instruct and mentor students throughout the program. A research thesis, completed during the second year of the program, is designed to demonstrate research skills. Students will also complete 240 hours of a clinical practicum in either an academic institution or in industry.

In addition to core coursework, graduates will develop fine-tuned clinical research skills as part of their successful completion of their practicum and research thesis. The dual degree program is appealing to those students who are interested in pursuing careers in the areas of academic medicine, health, and clinical research in either an academic or industry setting. Students completing the Program will be awarded a Master of Arts Degree in Medical Sciences and a Master of Arts Degree in Clinical Investigation.

Model Dual Degree Master of Arts in Medical Sciences and Master of Arts in Clinical Investigation

Option 1

(Required courses in bold)

Total Credits: 50 credits

Year 1 Fall Semester—17 credits

• BI 751 Biochemistry (6 cr)
• PH 730 Physiology (4 cr)
• AN 705 Medical Histology A (3 cr)
• CI 675 Design Clinical Research (4 cr)

Year 2 Fall Semester—8 credits

• CI 640 Regulatory and Compliance (4 cr)
• CI 670 Biostats with Computer (4 cr)
• CI 791 Practicum (0 cr)

Year 1 Spring Semester—17 credits

• PH 730 Physiology (2 cr)
• CI 631 Clinical Trials Management (4 cr)
• CI 790 Seminar in Clinical Investigation (2 cr)
• AN 706 Medical Histology B (3 cr)
• PH 750 Endocrinology (2 cr)
• PA 510 Immunology (2 cr)
• MS 640 Intro to Biomed Info (2 cr)

Year 2 Spring Semester—8 credits

• Elective (4 cr)
• Research or elective (4 cr)
• Thesis/Defense

Option 2

(Required courses in bold)

Total Credits: 50 credits

Year 1 Fall Semester—18 credits

• BI 751 Biochemistry (6 cr)
• CI 640 Regulatory and Compliance (4 cr)
• CI 675 Design Clinical Research (4cr)
• PM 730 Intro to Medical Pharmacology (4 cr)

Year 2 Fall Semester—8 credits

• CI 670 Biostats with Computer (4 cr)
• Elective/Research (4 cr)
• CI 791 Practicum (0 cr)

Year 1 Spring Semester—18 credits

• GMS PH 740 Physiology (6 cr)
• GMS AN 700 Medical Histology (6 cr)
• GMS PH 748 Endocrinology (2 cr)
• GMS PA 710 Immunology (2 cr)
• MS 640 Intro to Biomed Info (2 cr)

Year 2 Spring Semester—6 credits

• CI 790 Seminar Clinical Investigation (2 cr)
• CI 631 Clinical Trials Management (4 cr)
• Thesis/Defense

Overview

Clinical investigation is the fastest growing discipline in the burgeoning medical device and pharmaceutical industries. Keeping pace with the ever-increasing body of knowledge and new regulatory procedures generated by advances in clinical research is critical to career success.

The Boston University “Live” Graduate Certificate in Clinical Investigation—designed and offered by the Boston University School of Medicine—is an opportunity for clinical researchers, health professionals, and those interested in clinical research to gain an in-depth understanding of the scientific fundamentals of human research. Courses in the curriculum provide an in-depth look at a number of the key elements in clinical investigation, including: trial design and conduct, clinical research regulations, good clinical practices of research, and the critical evaluation of clinical research in the medical literature.

The “Live” certificate program consists of four courses:

• GMS CI 675 Designing Clinical Research Studies
• GMS CI 640 Regulatory and Compliance Issues
• GMS CI 790 Seminar in Clinical Investigation
• GMS CI 660 Good Clinical Practices in Clinical Research

Upon completion, students will have developed essential skills and understanding involving the elements and importance of good clinical research design, implementation, and practices. Clinical and health professionals of all varieties—including physicians, research nurses study coordinators, managers in clinical research and site management, and professionals in the pharmaceutical, biotechnology, and medical device industries, as well as CRO and SMO organizations—will benefit from this opportunity to:

• Earn a graduate certificate from Boston University’s School of Medicine, a leading research institution
• Complete a valuable professional credential in just four full semesters of study
• Apply a portion of the credits earned toward a Master of Arts in Clinical Investigation (MACI)
• Increase skills and knowledge in clinical investigation

Overview

Clinical investigation is the fastest growing discipline in the burgeoning medical device and pharmaceutical industries. Keeping pace with the ever-increasing body of knowledge and new regulatory procedures generated by advances in clinical research is critical to career success.

The Boston University Online Graduate Certificate in Clinical Investigation—designed and offered by the Boston University School of Medicine—is an opportunity for clinical researchers, health professionals, and those interested in clinical research to gain an in-depth understanding of the scientific fundamentals of human research. Courses in the curriculum provide an in-depth look at a number of the key elements in clinical investigation, including: trial design and conduct, clinical research regulations, good clinical practices of research, and the critical evaluation of clinical research in the medical literature.

The certificate program consists of four online courses:

• GMS CI 675 OL Designing Clinical Research Studies—Fall Semester
• GMS CI 660 OL Good Clinical Practices—Fall Semester
• GMS CI 640 OL Regulatory and Compliance Issues—Spring Semester
• GMS CI OL Critical Evaluation of the Medical Literature—Spring Semester

Upon completion, students will have developed essential skills and understanding involving the elements and importance of good clinical research design, implementation, and practices. Clinical and health professionals of all varieties—including physicians, research nurses study coordinators, managers in clinical research and site management, and professionals in the pharmaceutical, biotechnology, and medical device industries, as well as CRO and SMO organizations—will benefit from this opportunity to:

• Earn a graduate certificate from Boston University’s School of Medicine, a leading research institution
• Complete a valuable professional credential in just four full semesters of study
• Apply a portion of the credits earned toward a Master of Arts in Clinical Investigation (MACI) (Note: The MACI program is comprised of campus-based courses and is not available in an online format.)
• Increase skills and knowledge in clinical investigation

Tuition and Fees:

• Tuition: $925/credit hour = $3700/course
• Technology fee: $ 50/credit = $ 200/course
• Registration fee: $ 40
• Total cost per course: $3940/course