BADERC Clinical Research Core

David Nathan, MD, PhD

Director

Mary Larkin, RN, MSN

Co-Director

Purpose:

The BADERC Clinical Research Center will provide the services necessary for Center investigators to develop, design and carry out their funded individual human research projects efficiently, effectively, and cost-effectively.

Facilities:

Located in ~4,000 square feet of space specially equipped to perform human research on the MGH main campus, the BADERC CRC will provide space and all of the resources necessary to help BADERC investigators carry out their research studies. The current staff includes physicians, behavioralists and nurse investigators, research nurses and nurse practitioners, research dietitians, research coordinators and assistants, and administrative staff. Staff are cross-trained on studies, which provides seamless staffing of studies at all times. Research staff are trained in phlebotomy, sample processing, and other relevant research skills. A comprehensive training program in research methods is provided for all new research staff and refresher courses are offered. Appropriate competencies are tracked. All staff complete HIPAA and other MGH and MGB required training.  Most of the specialized equipment necessary to carry out diabetes/metabolic clinical research is available on site. Other resources, procedures and equipment, such as inpatient research beds, and DEXA equipment, are done on the MGH TCRC, part of the Harvard Clinical Translational Science Center, located on the main MGH campus one block from the BADERC CRC. The Diabetes Clinical and Research Assay Laboratory and BADERC core laboratories, which perform a variety of clinical and research tests, provide assay support.

Core Services:

  • Study planning/design
    • Planning consultation
    • Statistical support
    • Feasibility assessment
    • Identify populations
    • Budget planning and management
    • Methods
    • Protocol development
    • Pre-planning
    • Regulatory approvals
    • Interventions
  • Implementation
    • Development of procedure manuals
    • Hiring and training
    • Equipment
    • Interventions
    • Outpatient space
    • Site management
    • Study procedures/data acquisition and storage
    • Lab space/services
    • Recruitment and retention
  • Monitoring
    • Safety monitoring
    • Quality monitoring
    • Regulatory reporting
  • Results
    • Analysis and statistical support
    • Communication of clinically relevant results to participants
    • Dissemination
  • Study closeout

Cost:

A schedule of fees will be made available once this Core is established in the new funding cycle.