Design Your Study

"Getting Started" services support early development of study questions and design. There are five steps:

I.  Pre-protocol Development Meeting
II.  Community Engagement and Research Consultation
III.  Specimen Banking at Mount Sinai
IV. Data Mining at Mount Sinai

I.  Pre-protocol Development Meeting – The Office of Research Services will conduct a pre-protocol development meeting to address seven key areas for protocol development. ORS will help you develop your plan to address these issues or facilitate your access to Mount Sinai experts that can get you started.

• Scientific rationale and background
• Clinical characterization and sample recruitment, inclusion/exclusion criteria, recruitment plans
• Research design and analysis
• Data management and monitoring
• Patient safety and Data Safety Monitoring Committee
• Ethical considerations
• Budget development

Have a question on starting your study? For more information or to schedule a meeting, e-mail research.services@mssm.edu.

II.  Community Engagement and Research Consultation – The Centers for Community and Academic Research Partnerships' Center for Education and Training offers a consultation service to work with investigators on community-relevant research projects for issues from subject recruitment to full-partnered research. Through training and mentorship we provide support for selecting research topics, finding mentors, protocol development, time management, community engagement, and project management.

For more information, contact Crispin Goytia at 212-824-7323

III.  Specimen Banking at Mount Sinai – Are you planning a project that will include specimen collection, or would you like to know more about specimens that are available in Mount Sinai specimen banks?

IPM Biobank DNA Specimens – The Mount Sinai Biobank is a large collection of DNA and plasma samples that are stored in a way that protects patients' privacy, allowing research to be performed on de-identified clinical information from Mount Sinai's data warehouse system. For more information, click here.

Cancer Center Tissue Bank – Mount Sinai maintains a tissue bank of fixed and frozen tissue and fluids for patients who have signed consent. The specimens are stored in a way that protects patient privacy, while allowing research to be performed on de-identified clinical information from Mount Sinai's data warehouse system. For more information, click here.

Help with specimen banking – Biorepository Cooperative and Histology Service - The facility provides basic histology services, with capability to process, embed, and section fixed and frozen tissues for the Mount Sinai community. The facility will prepare unstained slides suitable for a variety of applications (histochemistry, immunohistochemistry, in situ hybridization, LCM), as well as hematoxylin and eosin sections for routine light microscopic evaluation.

The facility currently supports functions for tissue procurement, from both consented and anonymized collections. Pathologists in charge of procurement can be contacted for consultations to determine investigator requirements for human tissues in translational research, and then arrange procurement as feasible. For more information, click here.

IV.  Data Mining at Mount Sinai – Are you planning a project that will require data mining to identify potential populations?

Mount Sinai Data Warehouse – The Data Warehouse collects data generated by Mount Sinai's many patient care and business transactional computer systems. The source data are transformed into consistent and (where possible) standard formats, and stored in a large Oracle database. Master data (tables of diagnoses, caregivers, facilities, drugs, implants, etc.) that may differ among systems are aligned in the Data Warehouse. Tools are available to produce reports and/or datamarts supporting clinical and translational research, quality of care initiatives, and process and financial improvement projects. For more information, click here.

Research Databases – If you need help designing or developing a custom database for your research project, contact researchit@mssm.edu.

Community Engagement Public Health Databases
The Center for Community and Population Data Studies is in development under the leadership of Larry C. Kleinman, MD. This Center is intended to meet the needs of both community members and researchers who wish to ask questions that can be answered through the analysis of secondary data. Though housed in the Centers for Community and Academic Research Partnerships (CCARP), the Data Center is also a component of the Center for Bioinformatics and the Biostatistics, Ethics, and Research Design Program. It has three main functions:

1. Provide an accessible data resource for researchers, community partners, and faculty members.
2. Develop the data resource by obtaining databases, indexing them, and relating them to permit analyses to cross various databases, and develop user-friendly methods and procedures to access the data.
3. Expand the range of studies that can be accomplished using secondary data through the development and expansion of research methods and information science. We have a long-term goal of working with other CTSA-funded institutes to develop methods to identify which other neighborhoods and communities are comparable to our key communities of interest (Queens and East Harlem) to allow future studies of community factors to more easily cross neighborhood boundaries.

Individuals interested in contributing to the development of the Center or in using its resources should contact Dr. Kleinman at lawrence.kleinman@mssm.edu.