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.

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.

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

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

Costs

Service	Type of Cost	Rates
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	$200.00/hour
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		$100.00/hour
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	$50.00/hour
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	$100.00/hour
Biostatistician Developing a plan Perform data analysis Assist with manuscript preparation	Study staff time	$100.00/hour
Resources
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

David Nathan, MD, PhD

Director

Mary Larkin

Co-Director

Last Updated on June 21, 2022