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Academics

Clinical Trials

Overview

Clinical Trials are a key tool in the evaluation of new strategies for prevention and treatment of disease.  This certificate program focuses primarily on the design and analysis of randomized clinical trials for evaluation of licensed and non-licensed medical products and other health interventions, the regulatory framework for the conduct and evaluation of data from clinical trials, and ethical principles for the conduct of clinical trials. 

Educational Objectives

After completing the certificate, students will be able to:

Eligibility

The certificate program is open to graduate students currently enrolled in any division of the Johns Hopkins University, with the exception of MAS students, who are not eligble to apply until they have completed their primary degree program.  It is open to individuals who are not enrolled in degree programs at JHU.

Admissions Process

Applicants should review the How to Apply page for information about eligibility and special instructions.  The certificate program's review committee will review the applications and notify each applicant of their admissions decision.

Requirement for Successful Completion

The certificate requires at least 18 credit units that consist of core courses in clinical trials, epidemiology, and research ethics, as well as elective courses focusing on specific issues in the design, conduct and analysis of clinical trials.  The required courses in clinical trials include introductory courses in epidemiology, clinical trials design and interpretation and clinical trials methodology.  Students are also required to take at least 2 additional courses relating to clinical trials and 1 course in research ethics.

Each student will work with a faculty mentor to develop a protocol and plan for obtaining consent, e.g., prototype statement, for a randomized clinical trial.  The protocol will be 8 to 10 pages long and accompanied by consent statement(s) or other materials appropriate for obtaining consent for the proposed trial.  Students may complete this requirement in conjunction with a class or sign up for 1 to 2 credits of independent study for this project.  The credits for an independent study to work on the protocol can be counted towards the 18 credits required for the certificate program; in this case, the independent study course would replace one elective class.   Protocols and consent statements developed in the context of a class will be submitted to the student’s certificate mentor for review.

Students are strongly encouraged to participate in the seminars, research in progress meetings, journal club and other activities sponsored by the Center for Clinical Trials.

All required and elective courses must be taken for a letter grade and a 2.75 or better overall GPA for all Certificate courses is required.  The certificate program length is flexible; it varies from student to student, however, the program must be completed within three years. 

The student should review the section of the website that addresses completion before completing certificate program requirements. The student's transcript will not indicate that the certificate was earned until the Notification of Completion has been submitted, verified by the certificate program, and processed by the Registrar. 

Course of Study

Students should check the course catalog to confirm when the courses are offered.  The term and time may change from what is listed in the table below and some courses are only offered every other year. Students should also check for prerequisites and whether instructor consent is required.  

Course No.

Course Title

No. Credits

Online Term

Campus Term

 

Introduction to Online Learning

All students are required to complete this free course before taking other online courses.

0

1,2,3,4

Summer

-

550.860

Academic and Research Ethics at JHSPH

All students are required to complete this free online course during their first term of study.

0

1,2,3,4

Summer

-

Required Courses:  Students must take 3 required courses

Students must take either 340.601 OR 340.721, but not both
340.601Principles of Epidemiology OR5-S, SI

340.721

Epidemiologic Inference in Public Health

5

3

1

340.645

Introduction to Clinical Trials

3

1

2

340.694

Power and Sample Size for the Design of Epidemiologic Studies

1

3,SI

-

Students should take all courses in either Sequence A, B or C

Sequence A:
340.861Clinical Trials:Procedures, Design and Interpretation of Results 33-
Sequence B: 
340.633Data Management in Clinical Trials3-3

340.648

Clinical Trials Management

3

-

4

Sequence C:

340.633

Data Management in Clinical Trials

3

-

3

340.671

Topics in Management in Clinical Trials

2

-

SI

Other Clinical Trials Courses (2 courses required)

140.633

Biostatistics in Medical Product Regulation

2

1

-

140.634Non-inferiority and Equivalence Clinical Trials23-
140.642Design of Clinical Experiments3-3
223.664Design and Conduct of Community Trials4-3
223.690Design and Analysis of Cluster Randomized Trials2-4
223.705Clinical Vaccine Trials and Good Clinical Practice44-
340.606Systematic Reviews and Meta-Analysis6-3
340.686Introduction to Systematic Reviews and Meta-Analysis2-SI
340.840Independent study in Clinical Trials - students interested in pursuing this option should contact a faculty member before registeringVar-1,2,3,4
390.631Principles of Drug Development2-1
One of the following courses, but not both, may be counted towards the certificate program
410.649Introduction to Regulatory Affairs*  -
410.676Food and Drug Law* - 
Ethics (1 course required)
306.665Research Ethics and Integrity: US and International3-3
390.673Ethical and Regulatory Issues in Clinical Research321

SI=Course is offered in the Summer Institute in Baltimore

*Course is offered by the Johns Hopkins Krieger School of Arts and Sciences, Advanced Academic Programs.  Please visit their website for information about timing and registration

Sponsoring Department

Epidemiology

Contact Information

Certificate Program Contact
Name  
Fran Burman
Phone 410.955.3926

Email franburman@jhu.edu

Faculty Sponsor
Name Kay Dickersin

Faculty Co-Sponsor
Name Janet Holbrook

GAINFUL EMPLOYMENT PROGRAM INFORMATION

In accordance with US Department of Education regulations, the JHU Bloomberg School of Public Health is required to disclose graduation rate data, median loan debt data, and other select information for all Title IV eligible gainful employment programs.  To see the most recent data available for this gainful employment program, please view the attached disclosure.