Clinical Research Resources
The Boston University Clinical and Translational Science Institute (BU CTSI) Division of Clinical Research Resources supports researchers who have studies that involve human subjects. The division offers a physical location for implementing studies with human subjects, called the General Clinical Research Unit, and resources for recruitment, accessing clinical data and implementing studies. Our experienced staff also assists with study design and biostatistics, and offers education and consultation regarding regulatory issues.
Resources for Clinical Research
The division offers resources for clinical studies at Boston University Medical Center and ensures the proper use of these resources. We have supported translational research in a number of ways, including offering:
- A general clinical research unit, an outpatient unit on Evans 8
- A dental general clinical research unit
- Research staff to support studies beyond these physical locations
- Participant recruitment and retention consultations and tools
- A registry of participants interested in participating in research studies
- Access to the Boston Medical Center Clinical Data Warehouse
- Telephone interpretation
Click here for more information about research units, here for information about data warehouse access, and here for recruitment resources. For additional information please contact George T. O’Connor, Director, BU Profile Division of Clinical Research Resources at firstname.lastname@example.org.
Regulatory Knowledge and Ethics
We also ensure investigators understand and observe regulatory and ethical responsibilities as they conduct research. Our skilled staff offers education in these areas and can provide one-on-one or small group consultations and trainings.
Examples of our services include:
- Assistance with IRB applications
- Assistance with submissions of INDs and IDEs to the FDA
- Consultation on navigating research regulatory processes
- Investigator and participant education
- Study monitoring and assistance with implementing high quality clinical study processes
- Support for establishing data safety monitoring boards
Study Design and Biostatistics
The Study Design and Biostatistics Core assists researchers with study design, biostatistics and data management. Core members work closely with many types of investigators, including:
- Basic science researchers
- Researchers who test the safety, efficacy and effectiveness of new drugs and devices,
- Researchers who follow large samples of patients in observational studies to identify risk factors for disease
Our team is experienced with designing and analyzing clinical trials and observational studies, and is skilled in applying statistical genetics. We have assisted over 500 highly successful research projects at Boston University Medical Campus, including the Framingham Heart Study.
Our highly skilled team offers:
- Considerable experience in study design, innovative computer technology, data management and statistical methodology
- Access to on-going research developments in statistical methodologies, data collection, data management and computer technology
- Pedagogical activities encompassing principles of data management, biostatistical analysis, design and analysis of clinical trials, statistical genetics and statistical computing
- Physical facilities, equipment and computational resources
- Statistical consultation services through the Biostatistics Consulting Group of the Department of Biostatistics (for those not conducting research through the BU CTSI)