PROGRAM DESCRIPTION      top

The goal of the MGH Clinical Research Center (CRC) is to provide a clinical research infrastructure for clinical investigators who conduct patient-oriented research. The CRC can be used by investigators who are supported by the National Institutes of Health, other federal, state and local agencies, foundations, individual departments or by the private sector. The CRC is also an appropriate site for pilot studies that may lead to future NIH support. However, it is not intended to be the sole source of research support.

The clinical research support provided by the CRC includes inpatient and outpatient facilities, a core laboratory that performs non-routine, sophisticated analyses and procedures, a biostatistics core that can help with study design, data analysis, a Metabolism and Nutrition core that prepares research meals and performs nutritional measurements, anthropometry, metabolic measurements, exercise testing and body composition studies; and the necessary support personnel, such as research nurses, research bionutitionists, administration, informatics core manager, biostatisticians and others.

The investigations carried out in the CRC can include studies of normal and abnormal human physiology and studies of the cause, prevention, progression, treatment control and cure of diseases that afflict individuals from all backgrounds. Protocol applications to the CRC must adhere to NIH guidelines regarding inclusion of children, women and representation of all races and ethnicities. Collaborations between basic and clinical scientists are encouraged.

The CRC provides a unique environment for mentored training of health professionals in clinical research. Resources are provided to translate basic scientific discoveries into new diagnostic and therapeutic methods that improve health care.

The the NIH institute of NCATS serves as a catalyst for discovery for investigator-initiated studies. The NCATS provides a comprehensive range of human, technological, and other resources to enable biomedical research advances in approximately 80 sites around the country. In order to promote the mission of the NIH, the NCATS seeks scientific knowledge that will lead to better health and reduced illness and disability for our nation's citizens. The NCATS supports CRCs around the country in order to ensure continued important clinical research in a variety of clinical areas. We submit an annual report and financial status report to the NCATS in order to provide information to the NCATS on our scientific and financial progress and our activity level. We are funded from our competitive renewal grant application, in addition to non-competitive grant renewals submitted in intervening years.

The CRC is funded by a grant from the NCATS, an institute of the National Institutes of Health (NIH). The CRC grant is not intended to replace the usual mechanism of grant in aid for biomedical research by investigators or to substitute for departmental facilities which serve individual research needs. The CRC is also not intended to fund clinical research studies fully. Funding for non-clinical aspects of the research studies should be provided by peer-reviewed or non peer-reviewed sources. In some cases, the CRC is a resource to help in the gathering of preliminary data needed to obtain additional support.

In the process of achieving its primary objective, the CRC serves as a resource for the teaching and training of medical students, residents, fellows, and other health care professionals in the skills of clinical investigation. The CRC funds research fellowships to train future clinical investigators.

OUR LOCATIONS         top

Main CRC at Massachusetts General Hospital
Located on the Main Campus, on the 13th floor of the White Building, 55 Fruit Street. For driving direction, public-transportation,map and parking, please click here.

The Biomedical Imaging Center
Located in the Charlestown Navy Yard (CNY) Campus of MGH, in Building 149. For driving direction and parking, please click here.

FAQ           top

The CRC Advisory Committee (CAC)

What is the CRC Advisory Committee?
The CAC provides advice and direction to the CRC. CAC meetings are held every other month. The GAC discusses policy issues regarding the operation of the CRC, use of CRC resources, and submitted protocols and amendments.

Who are members of the CAC?
CAC members are appointed by the Principal Investigator. They include MGH staff who are generally active in clinical investigation.

GENERAL INFORMATION for NURSING AND BIONUTRITION/METABOLIC PHENOTYPING CORE   top

What are the specialized clinical skills that the protocol nurse and protocol research dietitian possess?
They are experienced in a full range of clinical specialties, including pediatrics, oncology, cardiovascular, psychiatry, endocrinology, neuroendocrine, reproductive endocrine, infectious disease, neurology and biomedical imaging and others.

Who designates the protocol nurse and protocol research dietitian to your protocol?
The Nurse director, Kathryn E. Hall assigns the protocol nurse. The Bionutrition/MPC director, Ellen J. Anderson, assigns the protocol research dietitian.

What are Unit Operations?
Unit Operations includes the unit environment, ie supplies, equipment, medical records, support staff.

How do I request a chart?
Charts are requested from the Operations Associate (OA) at the front desk.

Whom should I contact regarding subject-specific Doctor’s orders?
Please contact the study coordinator for the study.

Whom should I contact regarding general Doctor’s orders?
The assigned protocol nurse and assigned protocol research dietitian. Revised doctor’s orders must be e-mailed to Faith Fortune. She will place them on the shared network drive and notify nursing, bionutrition/MPC and administration that they have been submitted and that the orders need to be reviewed and approved.

Will the CRC provide study-specific supplies?
No. This is the responsibility of the study team.

NURSING   top

How do I follow-up with lab specimens?
Please contact the Nurse Director, Kathryn E. Hall MS, APRN, BC.

How long may I keep my lab samples on the CRC?
The samples that are stored in the CRC refrigerator or freezer must be removed from the CRC within 1 week.

What special skills can the nurses provide?
The nurses provide expert knowledge of clinical trials. The protocol nurse will have full understanding of your protocol and will be able to assist in the implementation of your study on the CRC.

The research subject’s nurse will do an assessment of the subject before and during the study. They will monitor the subject’s response to interventions, conduct frequent blood sampling and processing, and general monitoring of your research subject. The nurse will communicate with the investigator and study staff, assuring maintenance of the subject’s health status and integrity of the protocol.

There is a nurse practitioner on staff if one is needed for the conduct of the protocol.

METABOLISM AND NUTRITION RESEARCH   top

What special skills can the research dietitians provide?
The research dietitians provide special knowledge of clinical trials. The assigned protocol research dietitian will have strong familiarity with your study and will assist you in getting your study started on the CRC. The research dietitians can complete metabolic cart measurements, prepare special weighed meals, perform exercise physiology testing and determine nutrient intake(s).

How do I utilize a research dietitian for my study?
Request bionutrition services in the Turbo application. There are specific questions about the type of services needed in the Turbo application.

How do I arrange for a meal tray?
Inpatient research subjects will be provided with a meal tray as part of their inpatient stay. If there are special needs for the meal (i.e. low salt, low cholesterol, modified carbohydrate, etc.), these must be reflected in the Doctor’s Orders. A meal tray for a long-term outpatient visit should be requested as part of the protocol application.

How do I receive access to the scheduling program?
Complete and e-mail a CRC New User Form to Faith Fortune. Faith will then enter the new user into the Staff Application Program and will then notify the user via email with the User Number and Password to the program. The Instructions for Request Appointment will be attached to the email.

What is the process for scheduling my subject’s visit?
All requests for inpatient days or outpatient visits must be submitted through the Turbo scheduler. Requests are reviewed and processed to match space and staff for optimum utilization.

How do I cancel a subject visit?
Cancel the visit through the Turbo system. This is critical for ensuring the smooth processing of all scheduling requests and accurate reconciliation of our census.

How long should it take to receive a response to a scheduling request?
You should receive a response to your request within 48 business hours.

How do I request a space-only visit on the CRC?
Please indicate this on your Turbo schedule request.

How do I request a special room (sleep room, Laminar air flow) for my study?
Indicate this on the Turbo application. You should also indicate this in the comment field when you submit a request for an individual visit.

TURBO PROGRAM AND PROTOCOL SUBMISSION   top

How do I use the Turbo program?
To learn more on how to use the Turbo program, please schedule a time to meet with Faith Fortune for a one-on-one training session.

How do I make a revision to my Turbo file?
Please contact Faith Fortune to receive the most updated turbo file for editing.

Please see instructions in the How to Apply section.

What do I need in order to submit a new protocol to the CRC or a Core Only protocol?
The Protocol Submission Requirements document describes the process and can be found on our website in the How to Apply section under the Info for Investigators, or you may contact Faith Fortune for a copy of the document.

PROTOCOL APPROVAL   top

How long is the study approval process?
Studies are generally approved on the CRC by CAC within 60 days. Approval of a study could be affected by a late HRC approval and/or delays in responses from the CRC reviewers and/or investigator.

What is the process for approval of a protocol?
There is a separate document detailing this on our website. In summary, the CRC protocol team, including scientific reviewers, reviews the protocol and provides comments on a critique sheet. The critique sheet is edited and then forwarded to the Principal Investigator for response to the comments. Approval is contingent on completion of completion of finalizing study orders, computer systems for scheduling visits and visit preparation. Once this process has been completed, an approval letter will be sent to the PI from Faith Fortune. Scheduling commences when study is approved.

Will the CRC application process be coordinated with the HRC application?
There are plans to coordinate these efforts. In addition, the Turbo application is in the process of being reviewed and revised for clarity and ease of submission while still capturing information that we are required to collect for our sponsor.

What is the protocol review process for “core-only” protocols?
Core-only protocols (i.e. Core Lab, Metabolism and Nutrition, Biostatistics, Biomedical Imaging etc.) undergo a review that is limited to the Core group, administration, and scientific reviewers.

CRC ANNUAL REPORT SUBMISSION   top

What is the CRC Annual Report?
An Annual Report must be prepared by the CRC in accordance with NIH guidelines. Each November, CRC Administration distributes a form reflecting current requirements to all Investigators with active protocols which had patient activity or active Core use during the current funding year 5/01/__ - 4/30/__. It is an NIH requirement that the annual report documents be completed.

Who needs to complete the CRC Annual Report?
Any principal investigator with a protocol that was active with subject activity or used a CRC Core during the CRC grant funding period of May 1st to April 30th of each grant year.

FINANCIAL QUESTIONS   top

When do the CRC outpatient and inpatient fund numbers change?
These fund numbers change every year on May 1st.

Why do the CRC’s fund numbers change every year?
The CRC’s funding is renewed through a yearly non-competitive renewal. As a result, the funds need to be managed on a year-to-year basis.

How do I obtain the CRC fund #?
Contact the Administrative Director, Ed Andrews, at 617-726-6885 or ebandrews@partners.org.

What is the significance of the different NCATS protocol categories?
An “A” study is an investigator-initiated protocol. These are most often NIH-sponsored studies, but an A study could also be funded by foundations, departmental funds, other governmental agencies or private sponsors. A studies take priority over D studies when the CRC is space-constrained.

A “D” study is a non-investigator-initiated protocol. These are generally supported by private sponsors, such as pharmaceuticals, biotechnology or medical device companies. The CRC cannot pay for ancillaries or bed days for "D" studies.

A Scatter bed is an inpatient study that is for an approved protocol, but conducted on another unit of the hospital.

How much will the CRC support in ancillaries for my study?
The CRC grant permits coverage up to $75 per outpatient visit or $100 per inpatient day. This amount is calculated on a per-visit average and could be subject to change, based on budgetary limitations. We will also notify investigators late in the CRC grant year if there will be additional funds available. If this is the case, the additional funds would be distributed on a priority basis. The research rate for ancillaries is the same for A and D studies.

Will the CRC pay for some offsite visits?
Yes, the CRC will pay for ancillaries for offsite visits if there is prior approval from CRC Administration.

What if our research subject receives a bill for a study visit?
Please fax [617-724-3299] or deliver the bill to White 1301 or invoice to the CRC administration and we will investigate. If it is appropriate for the CRC to pay for services on this invoice, we will provide the fund # to the billing agency. If it is not a service covered by our grant, we will notify you of this as well.

Will the CRC pay for professional fees?
CRC regulations prohibit our funds from being used for payment of professional fees.

Will the CRC pay for subject payments?
The CRC will pay for subject payments under certain conditions and if there are funds available. Please contact the Administrative Director for any questions.

CORES   top

How do I utilize a biostatistician for my study?
Check off “Biostatistician” on the resource section of the Turbo application.

What support can the biostatistician provide?
The biostatistician can provide sample size calculations, training and education, study design, data analysis and manuscript production.

How can the biostatistician assist with the Data Safety Monitoring Board (DSMB)?
A biostatistician can serve as a member of a DSMB, or can provide a statistical report to the DSMB.

How do I utilize the Biomedical Imaging Center?
Check off “Biomedical Imaging Core” on the resource section of the Turbo application.

Please see the Biomedical Imaging Core

How do I utilize the Core Lab?
Check off “Core Lab” on the resource section of the Turbo application.

Will the Core Lab pay for kits?
The Core Lab doesn't’t have the funds to pay for kits. The investigator must provide kits for processing lab samples in the core lab.

RESEARCH SUBJECT ADVOCATE (RSA) PROGRAM   top

What is the role of the RSA program?
The role of the RSA is to evaluate individual protocols and the overall program to ensure the highest level of research subject safety.

How do I access the RSA?
Please contact the RSA Director:
Dr. Enrico Cagliero:
617-726-1847
ecagliero@partners.org

What is a CRC Data Safety Monitoring Plan (DSMP)?
This plan is required for every study. The investigator will identify the demographics of the study and the expected risk of the study. For further information and assistance with outlining a DSMP, please see the Data and Safety Monitoring Guidelines.

How do I apply for use of the CRC Data Safety Monitoring Board (DSMB)?
You may request the DSMB through the DSMB application associated with Turbo application.

FUNDING SOURCE    top

INSTITUTIONAL REVIEW BOARD (IRB)      top

Please visit their website at http://healthcare.partners.org/phsirb/home.htm for information on the Partners Human Research Committee

CRC ADVISORY COMMITTEE (CAC)        top

Membership on the CAC is open to key CRC staff and select MGH investigators. CAC members are responsible for approving key issues and reviewing new protocol submissions.

NURSING       top

Contact: Kathryn E. Hall, MS, APRN, BC

Each active protocol conducted on the CRC with a nursing component has a Protocol Nurse, who:

• Participates in the review of protocols in the CRC Advisory Committee approval process
• Collaborates with study team to develop research data collection tools, case-report forms (CRFs) and teaching tools.
• Reviews Study Orders to implement the study protocol and ensures protocol integrity.
• Educates CRC staff for protocol integrity.
• Conducts regular evaluation of protocol progress with Principal Investigator, study staff, and CRC clinical staff.
• Promotes clear communication among CRC staff and research personnel.
• Conducts nursing assessments for all study volunteers.
• Designs a plan of care that ensures subject safety, maintenance of subject's health state, prompt determination of adverse events, protocol integrity and a plan for self-care and follow-up at completion of visit and protocol.
• Monitors subjects' physiological and psychological status throughout the study.
• Collects and processes clinical laboratory samples.
• Administers study medication and observes subject's response.
• Implements protocol teaching (initial and ongoing); evaluates study participant’s understanding to promote study compliance and maintenance.
• Collaborates with all disciplines involved in conduction the study, coordinating study and care activities.
• Conducts ongoing assessment and evaluation of protocol compliance and subject response.
• Active communication with study staff and investigator to evaluate findings and modify plan of care and protocol when necessary.
• Designs and conducts research for nursing questions that support and extend the study questions.
• Participates in preparation of study findings for presentation and publication.
• Uses the clinical resources of MGH Patient Care Services to support care of the subject.
• Participates in research protocol review with membership on Partners HRC committees and MGH Patient Care Services collaborative governance committees.

METABOLISM AND NUTRITION RESEARCH       top

Contact: Ellen J. Anderson, MS, RD

The metabolism and nutrition research is a core resource within the Harvard Catalyst, Clinical Translational Science Center (CTSC), Participant and Clinical Interactions Resource (PCIR). The MPC supports subject routine and research meals; nutrition intake data collection and analysis; and metabolic assessments using a variety of modalities. The MPC inpatient, outpatient, and/or extended off-site facilities and personnel provide investigators a specialized infrastructure of high quality nutrition services that might otherwise be unavailable or prohibitively expensive.

The metabolism and nutrition research is comprised of experienced research registered dietitians (RDs) and support staff. The highly trained RDs collaborate with the Principal Investigator with writing grant applications including research design and budget planning, as well as developing a comprehensive plan for the study review and implementation procedures. As an integral study team member, the RD educates the clinical research staff regarding the nutrition component of the study protocol, and interpretation of nutrition data. Data review and manuscript preparation are additional services available upon study completion.

• Collaborates/consults with Principal Investigator on research study design.
• Collaborates with research team to develop research forms, including data collection forms, subject education, assessment of compliance, and activity assessment.
• Educates and evaluates study volunteer on protocol specifics to optimize compliance.
• Develops/implements specialized weighed meals, controlled for single and/or multiple nutrients.
• Performs anthropometric measurements including stature, weight, skinfold, impedance and circumference for determination of body composition.
• Determines energy expenditure using indirect calorimetry.
• Determines bone mineral density and body composition using DEXA.
• Analyzes nutrient intake from calorie intakes, food records, 24-hour recalls and food nutrient questionnaires.
• Provides standard and research meals to inpatient and outpatient volunteers.
• Participates in protocol meeting(s).
• Evaluates protocols initially and on an on-going basis with team members including CRC staff, investigators and study staff.
• Monitors quality assurance, including equipment calibration, anthropometric measurements, nutrient analysis, and food preparation.
• Maintains nutrition census, including meals served and assessments completed.
• Compiles nutrition data spreadsheets and statistical analyses which may include nutrient intake, anthropometric data activity.

CORE LABORATORY        top

Contact: Lorna Lampert, Laboratory Supervisor

The primary functions of the Core Laboratory are to provide sophisticated support for ongoing CRC protocols and to develop or validate new methods for this purpose. In addition, the laboratories may provide clinical research training for investigators, fellows, students and lab technicians.

• Provides Principal Investigator with timely and accurate laboratory determinations, not otherwise available through other clinical labs.
  
• Conducts special processing and assay methods. For assays we offer, please click here.
  
• Provides clinical laboratory research training for Principal Investigator, post doctoral fellows, students and lab technicians.

BIOMEDICAL IMAGING CORE       top

Contacts:
TBD.
Phone: TBD.

• Support clinical research studies located at the Charlestown Navy Yard campus including provision of exam rooms, expert nursing staffing of exam rooms and imaging facilities, including the MRI and MEG scan suites.
  
• Support for physiological data acquisition in exam rooms and imaging facilities, including the MRI and MEG scan suites.
  
• Specialized statistical consultation and support for biomedical imaging studies.
  
• Support for medical imaging analysis and data management.

• For more detail, please visit the biomedical imaging core web site

BIOSTATISTICS       top

Contact: Dianne Finkelstein, Ph.D.

• Assists in the planning, design and evaluation of clinical research.
  
• Consults and may collaborate, with investigators on study design, implementation, analysis, interpretation and dissemination of results.
  
• Develop new statistical methods as needed for specific projects.
  
• Trains clinical researchers in the principles of study design and analysis.

  Web-based sample size calculation program – from David Schoenfeld, Ph.D.
  Click Here

INFORMATICS       top

A clinical investigator must be able to publish his/her scientific findings. This requires that data be (1) collected accurately, (2) monitored appropriately, (3) secured, (4) managed effectively, and (5) accessible through the following means:

• Ensures current technology are employed to meet CRC’s goals.
  
• Assist in the organization and analysis of research data.
  
• Design and develop methodologies that meet standards.

Administration        top

Contact: Edwin B. Andrews

• Provide support to the CRC Advisory Committee.
  
• Process new applications and amendments.
  
• Coordinate protocol review with all disciplines and sciences.
  
• Provide budgetary support per the CRC grant.
  
• Review and approve ancillary requests for individual protocols.
  
• Develop annual budget for sponsor.
• Provide annual financial and project reporting to the CRC sponsor.
  
  

   

CONTACT US          top

For immediate clinical operation issues, please contact:
617-726-3294 White 13
617-726-0807 CNY

Address:
MGH Clinical Research Center (CRC)
Massachusetts General Hospital
55 Fruit Street - White 13
Boston, MA 02114
617-726-4272

Program Director: David M. Nathan, M.D.
Phone: 617-726-2875
Fax: 617-726-6781
dnathan@partners.org

Administrative Director: Edwin Andrews, MPA
Phone:617-726-6885
Fax: 617-724-3299
ebandrews@partners.org

Administrative Manager: Deborah Gandre
Phone: (617) 724-9487
Fax: (617) 724-3299
dgandre@partners.org

Administrative Coordinator: Faith Fortune
Phone: (617) 726-6886
Fax: (617) 724-3299
ffortune@partners.org

Metabolism And Nutrition Research Director: Ellen J. Anderson, MS, RD
Phone: (617) 724-2830
Fax: (617) 726-7563
eanderson1@partners.org

Biostatistics Director: Dianne Finkelstein, Ph.D.
Phone: (617) 726-66111
Fax: (617) 724-9878
dfinkelstein2@partners.org

Core Lab: Lorna Lampert, Laboratory Supervisor
Phone: (617) 726-3692
Fax: (617) 726-6781
llampert@partners.org

Nursing Director: Kathryn E. Hall, MS, APRN, BC
Phone: 617-726-3295
Fax: 617-726-7563
khall7@partners.org

RSA Director: Enrico Cagliero, M.D.
Phone: 617-726-1847
Fax: 617-726-1871
ecagliero@partners.org

Biomedical Imaging Core