Protocol Implementation

Participant & Clinical Interactions

Individuals’ voluntary participation in research studies is a critical success factor for the research enterprise. But such participation can only be assured when research is conducted in compliance with rules and regulations and to the highest ethical standards.

CTSI is acutely aware of the public’s concerns about the safety of medical research studies, industry’s concerns about protocol compliance and completion, investigators’ complaints about burdensome regulatory and training requirements, and everyone’s concern about lack of reproducibility, and incomplete and unreported results. Consequently, we are committed to the adoption and implementation of innovative policies and infrastructure that improve the quality of human subject protections and promote a culture of responsibility, while streamlining institutional bureaucracy—and minimizing burden and delays—across all participating institutions and organizations.

To this end, CTSI has developed several strategies to ensure that investigators and their study teams are well-trained on regulatory and institutional requirements and good clinical practices (GCP). Altogether, 1300 faculty and staff researchers receive GCP training—advanced and basic—each year.

Beyond the extensive training provided, other checks are in place to ensure compliance:

  • The BU Medical Campus/Boston Medical Center IRB approves, monitors, and reviews biomedical and behavioral research involving humans and assures that each study’s design minimizes risk to subjects. The IRB review process is being streamlined to expedite the start-up of human studies while assuring the highest standards of human subject protection and research quality.
  • Our Quality Assurance (QA) Program has been developed to (1) ensure that rights and safety of human subjects are protected and (2) assure the validity and integrity of the research data. QA audits examine a number of study components including whether all team members have the required qualifications and training, the recruitment and enrollment procedures, study documentation, the completeness of the regulatory binder, whether subjects meet eligibility requirements and documentation of informed consent.
  • As some translational research data are sensitive, CTSI developed the Secure Clinical and Translational Research Network (SCTRN) to enable unstructured data to be stories in a protected area accessed only via virtual desktops. Sensitive data cannot be transferred to a location where it is subject to theft. Approved under the Federal Information Security Management Act, SCTRN ensures rigorous protection of clinical data and is available across the CTSA network.

Overview

The General Clinical Research Unit (GCRU) at CTSI provides resources to faculty at the BUMC, including a controlled and optimal setting for clinical investigators, career development programs, and training for health professionals. The GCRU is currently the setting for a large number of active protocols; it is also part of a national network of 62 academic medical institutions across the country that offer infrastructure and clinical investigation resources. Examples of resources provided by the GCRU include:

  • The ability to conduct pharmacokinetic studies in a controlled environment with both adult and pediatric inpatients and outpatients
  • Resources for timed collection of specimens and other specialized testing (bone density, CT scan, etc.)
  • A private environment to explore patterns of behavior
  • A primary location for the education of future physicians, scientists, and nutritionists in patient-oriented research

CTSI offers resources to investigators in medicine and dentistry funded by various sponsors including federal, non-federal, and industry, as well as those conducting innovative clinical research pilot studies, prior to requesting funding. Experienced medical professionals help by facilitating the day-to-day research activities for physicians, trainees, and participants. The GCRU boasts a highly trained research staff of eight who support inpatient and outpatient, adult and pediatric, medical and dental studies that discover the cause, progression, prevention, control, and cure of human diseases. For specifics on services available, please contact the Director of Clinical Research Operations, Ridiane Denis, at Ridianed@bu.edu or call 617.358.7558.

General and Clinical Research Unit Rates

The GCRU has developed separate fee structures for Investigator-Initiated studies (NIH; DoD; Private Foundations; etc. ) and for Industry Funded studies. The fee schedule includes the various levels of services provided by the GCRU per type of study.

Method of Payment

Following receipt of an approval letter for use of the unit, investigators will be asked to submit a completed GCRU Usage Billing Form, providing an account number which will be charged for services. An invoice for services will be sent monthly to the investigator with five business days for review, after which time the account will be charged by internal journal entry. Fees will be reinvested in program resources to continue support of translational research.

Scheduling

The BU-CTSI web-based scheduling system allows project coordinators to request appointments for participants in studies that use the GCRU.

After approval of the study, coordinators must be authorized to use the online system. A brief (30 minute) hands-on tutorial is offered to familiarize users with the system and to answer any questions.

Visit the CTSI scheduling system website. You will be prompted for your BU Kerberos username and password. For more information, please contact Mary Ann Ingaciola, at mingacio@bu.edu.

Application

Apply to conduct a study in the GCRU
GCRU Application Instructions
Billing and Scheduling Worksheet
Nursing Flowsheet
Lab Template

New Services Offered

Special consideration is given to studies where it is physically impractical for participants to come to the Evans building (e.g participant in hospital). In these cases, services are offered through our “GCRU without walls“, where GCRU staff can go to your participant to provide requested services. For more information, please contact the Director of Clinical Research Operations, Ridiane Denis, at Ridianed@bu.edu or call 617.358.7558.

CPR certification and Phlebotomy training are now available.

  • CPR new certification is $75, and offered on the 2nd and 4th Wednesday of every month, 9:30 – 11:30 am.
  • Phlebotomy new certification 3 day training is $350, and offered on the 3rd week of every month, Wednesday – Friday, 9:00 – 11:30 am.

Register for a training!

Locations & Contacts

Find more information on the Participant & Clinical Interactions faculty and staff here.
Although the GCRU hours of operations are Monday – Friday 7 am – 4 pm, special arrangements can be made for after hour and weekend visits.