BADERC Clinical Research Core

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.


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.

The Clinical Core allows investigators access to the resources of a premiere diabetes clinical research center which has led both seminal multicenter and investigator-initiated observational diabetes studies and diabetes clinical trials. Leveraging these resources including the director and assistant director’s mentorship on protocol development, the extensively trained research nurses and coordinators, as well as the well-equipped facility itself has allowed me to successful compete for funding to join multicenter consortia as well as successfully execute investigator-initiated studies of glycemic physiology in pregnancy.
Camille Powe, MD, BADERC Member

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
  • 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
  • Safety monitoring
  • Quality monitoring
  • Regulatory reporting
  • Analysis and statistical support
  • Communication of clinically relevant results to participants
  • Dissemination
Study closeout


Type of Cost
Protocol Implementation
Consultation with RN manager re study start up and feasibility
  • Manger reviews application for study to be conducted at the BADERC CRC, study protocol, and study manuals if available.
  • Meet with PI to decide on feasibility to conduct at BADERC CRC
  • Discusses with PI the specific services that would be needed
  • Manager determines staff level, time and skill level required
Consultation, Management, Supervision and Training staff time
Consultation with Dietician regarding nutritional aspects of protocol
Hiring of study staff, as needed
  • Manager prepares job description and interacts with HR
  • Manager orgainizes interview teams and plans orientation
  • Operations Manager assists in HR/Orientation
Training of study staff appropriate to task, as needed*
  • Review of protocol and materials
  • Specific study certification
  • Hospital trainings
  • Competency assessment
Supervision of study staff, study progress, problem solving
  • Manager oversees study visits, procedures, attends staff meetings with PI and team when available, higher amount of time spent during study planning, training and start up, changes to maintenance once up and running smoothly
Research Assistant/Coordinator services
  • Phlebotomy
  • Tube prep and labeling
  • EPIC orders
  • Blood processing and short term storage
  • Shipping to outside labs
  • EKG
  • Urine samples
  • Vitals, height/weight, other procedures within scope as per protocol
  • Prep of source docs visit checklists and red cap if needed
  • IRB prep and submissions
  • Regulatory binder maintenance
  • Data entry
  • Pick up meds from pharmacy
  • Scheduling and reminders calls
  • Enrolment, AE, deviation inventory logs
  • Laboratory support
  • Recruitment plan by senior coordinator*, and actual recruitment
Study staff time
RN services
  • IV starts and blood draws
  • Medication dispensing
  • Consulting with pharmacy for med labeling, packaging, EPIC build
  • Procedures/visits requiring nurse time as applicable per protocol
  • OGTTs
  • Medical history and med review
  • Participant education
  • Review of labs
Study staff time
  • Developing a plan
  • Perform data analysis
  • Assist with manuscript preparation
Study staff time
  • Exam room space
  • Cube space
  • Phone, computer, copier, printer, centrifuges
  • Assistance from office manager for study operations
  • Conference room space for meetings
  • Study specific tasks, to be negotiated
  • Standard supplies (some space for storage of supplies available)
  • Financial services:
    • Develop a budget for each study
    • Consultation with grants manager for cost planning/estimation preferable before budgets submitted to funders
    • Financial oversight (spend rates, etc)
    • Invoicing for services rendered
Operating cost Annual Fee $2,500

Last Updated on June 21, 2022