Educational Objectives
The certificate program is designed to enhance clinical scientists’ theoretical and practical skills in design, implementation, and interpretation of data from clinical investigations. The certificate will train clinical scientists in five core areas of Clinical Investigation.

Upon completion of the training certificate, students will be able to:

- Critically evaluate strengths and weaknesses in study design
- Read, understand, and critically discuss quantitative methods used in the scientific literature on clinical investigation
- Explore and examine ethical issues and regulatory requirements central to clinical research
- Acquire basic concepts of relational database design for clinical and basic research including development of data collection forms, design of a relational database, data quality control, and importing and exporting collected data across different platform
- Explore experimental and observational designs, alternative approaches to addressing confounding in controlled observational studies, methods for evaluating the effectiveness of patient-level interventions, and methods for evaluating the effectiveness of providers and provider-level interventions

Intended Audience
- Scientists, clinicians, or support personnel fully engaged in clinical investigation
- Regulatory personnel involved in IRBs, DSMBs, and oversight of human subjects research
- Post-doctoral trainees in the clinical disciplines who would like an overview of the requirements of clinical investigation
- Students matriculated in a University degree program are not eligible for the training certificate

Admissions Criteria
Admission to the certificate program may be granted to faculty, trainees, and staff of the medical institutions who are or expect to be fully engaged in clinical investigation. In addition, non-Hopkins affiliated investigators and their staff may enroll with appropriate credentials and prerequisites.

Applicants must submit an application to include evidence of successful completion of a Baccalaureate or advanced degree, evidence of previous or ongoing involvement in the clinical research enterprise, and for those without a degree, a letter of reference from supervisory personnel or employers.

Course of Study
SOCI Training Certificate candidates will complete two required and two elective courses. For the certificate, the courses are to be taken as not-for-credit. The certificate program is not open to University degree students.

Courses and Credit Equalivents

Required courses:
390.676 Design of Clinical Studies (3 credits)**
390.672 Quantitative Analysis of Clinical Data** (3 credits)

**Courses are open to SOCI certificate students ONLY

Students must also complete two of the following:
390.841 Database Design and Implementation in Clinical Research (2 credits)
390.673 Ethical and Regulatory Issues in Clinical Research (3 credits)
390.675 Outcomes and Effectiveness Research (3 credits) Note: Courses are offered on-campus in 2009-10, with the intent to convert much of the course content to the distance-learning format for 2010-11.

Requirements for Successful Completion
SOCI Training Certificate candidates must satisfactorily complete two required courses, and two of three elective courses. The training certificate must be completed within three years of entry to the program.

Faculty Sponsor
N. Franklin Adkinson, Jr., MD

410.550.2051

fadkinso@jhmi.edu

Administrative Contact
Cristina DeNardo

410.502.9734

gtpci@jhsph.edu

Administrative Contact 2
Bobbi Nicotera

410.502.6965

bnicote1@jhmi.edu