Consultations
DCR provides a variety of consultations and services to assist investigators and staff with specific projects. All consultations up to 6 hours are free. Additional information about service fees beyond initial consultation can be discussed at project initiation.
Bioinformatics
The goal of the Massachusetts General Hospital Bioinformatics Consortium is to provide bioinformatics and wider genomics service, consulting, education, and training for biological, preclinical and clinical investigators at MGB. Combined with our wet-lab capabilities for next-generation sequencing, the Bioinformatics Consortium provides a fully integrated resource for genomics studies in both preclinical and clinical settings. We help our partners design and execute experimental or clinical data generation and management, as well as implement best practices for quantitative analysis in order to produce powerful and relevant biomedical data.
Ruslan Sadreyev, Ph.D
Biostatistics
The mission of the Biostatistics Center is to engage in impactful trans-disciplinary collaborations involving quantitative methods in public health and biomedicine. Our faculty and staff develop, evaluate, and apply rigorous statistical and data science methods across a broad spectrum of research areas. These include studies in cancer, cardiology, emergency medicine, psychiatry, pediatrics, infectious diseases, neurology, and many other areas of clinical and translational research. We have shared expertise in methods for clinical trials, observational studies, clustered and longitudinal data, missing data, survival analysis, machine learning, genetics and genomics, implementation science, and precision medicine applications. We always welcome new collaborations!
Andrea Foulkes, ScD
Biostatistics for K Awardees
Our faculty are passionate about helping junior investigators design appropriate statistical methods and approaches for career development grants, or K grants, to answer their scientific questions and further their research careers.
Hang Lee, PhD
Clinical Research Education
The Center for Clinical Research Education (CCRE) develops and maintains a comprehensive curriculum for clinical research. We also support the wider MGH and MGB research communities through developing educational material, hosting educational events, and providing consultations instructional design and teaching strategies. Learn more about our services on the Education page.
Jamie Quinkert, PhD
Community Outreach and Access
The Center supports investigators in establishing connections with MGB’s community health centers to broaden and enhance clinical trial recruitment efforts. Faculty members can advise and collaborate with investigators interested in recruiting participants or forming partnerships within local communities. They also guide the development of comprehensive recruitment plans and the creation of outreach materials.
Julie H. Levison, MD
EHR Data Acquisition
Our team supports researchers in designing studies and acquiring, cleaning, and integrating health record data from various sources, including Epic, Research Patient Data Registry (RPDR). Snowflake(Electronic Data Warehouse- EDW), and COVID-mart and the MGH and BWH Primary Care Longitudinal Cohort (PCLC). We assist with data extraction for specific variables, cohort identification, and troubleshooting data discrepancies, ensuring comprehensive and accurate datasets for your research needs.
To start working with the DCR, download the analysis plan template, example, and example appendix before requesting your consultation.
To start working with the DCR, download the analysis plan template, example, and example appendix before requesting your consultation.
James B. Meigs, MD, MPH
Finding Research Collaborators
The DCR is a hub of MGH and has deep institutional knowledge of the research being done, and we are happy to facilitate connections with investigators across the institution, the system, and Harvard Catalyst.
Takara Stanley, MD
Grant Writing (non-K)
Our experienced faculty offer grant writing consultations for investigators making the transition from career development grants, or K grants, to their first independent investigator grant, or R grants.
David M. Nathan, MD
Takara Stanley, MD
K Grant Writing
Our faculty offer grant writing consultations for aspiring investigators writing career development grants, or K grants. These consultations include advice on identifying appropriate mentors, career development plans, specific aims, and the mechanics of grant writing.
Karen Miller, MD
Manuscript Proofing Support Service
The DCR CCRE team can support investigators requiring help with comparing their manuscripts with iThenticate. Investigators can utilize the helpful tip sheet to run reports on their own or reach out to the CCRE team for help with running these reports. Please submit a DCR consult request at dcr.mgh.harvard.edu to select if you will be using the tip sheet or requiring help to run the report. Please note that iThenticate and other AI tools should be used in addition to your own expert review.
Jamie Quinkert, PhD
Ava Truant
Munn Center for Nursing Research
The Munn Center supports nursing research initiatives that advance clinical practice and optimize quality patient-centered outcomes. The Munn Center also supports the MGH Clinical Research Nurse Collaborative. Checkout the Munn Center’s website to learn more.
Jennifer Cahill, PhD, RN
Nursing Research
Experienced clinical research nurses of the Translational and Clinical Research Centers are available to provide an array of resources and support.
Kathy Hall, NP
Omics Research
The Omics Unit in the DCR assists investigators in genetic and genomic study design and execution. Omics consultations from the DCR are designed to assist investigators in genetic study design and execution, human subject protection, career advice and resource identification. The Omics Unit also focuses on emerging technologies for metabolomic and proteomic profiling of human samples, with the goal of optimizing sample throughput, cost and breadth of analytical coverage.
Jordan W. Smoller, MD, ScD
Participant Recruitment and Retention
The Participant Recruitment and Retention Unit (PRRU) helps study teams enhance participant recruitment and retention efficiency and effectiveness in clinical trials. Faculty provide coaching, training, and guidance to study teams to address barriers to participation, ensuring a broader representation of participants and maintaining participant engagement throughout the study. The unit also provides expert instructional design support in developing multimedia tools and direct, hands-on study coordinator support for screening and recruiting participants.
Andrew Nierenberg, MD
Vidya Iyer, MBBS
Patient-Centered Outcomes Research
The Patient-Centered Outcomes Research (PCOR) Unit of the DCR was established to address the research needs and funding opportunities provided by the creation of the Patient-Centered Outcomes Research Institute (PCORI). The PCOR Unit seeks to facilitate research through proposal preparation consultations, outcome measure support, and stakeholder engagement assistance to help investigators who are navigating the waters of the Patient-Centered Outcomes Research Institute or conducting PCOR studies.
Andrew Nierenberg, MD
Philanthropy Education
The Philanthropy Education Unit coordinates meetings between past and present investigators at MGH to brainstorm the best ways to raise philanthropic support for clinical research projects. The unit also provides educational opportunities for junior investigators to share best practices for obtaining philanthropic support, approaching potential donors, and working with the MGH Development Office.
Lee Cohen, MD
Project Management
Project Managers (PMs) provide administrative support throughout the clinical trial continuum from study start-up to study close-out.
Project Managers assist investigators in administrative, regulatory, financial, study and data monitoring, data management, and study conduct activities, following ICH GCP guidelines, FDA, sponsor, and MGB policies and regulations.
For any additional Project Management service not listed here, please email dcrccre@partners.org
A comprehensive list of services includes:
- Protocol feasibility assessment
- Protocol development and writing
- Administrative assistance with FDA IND/IDE application submissions, including single IND or Expanded Access Protocol (EAP) submissions
- IRB submissions: initial study submission, responding to queries and tracking the application status, continuing review, and protocol amendment submissions
- Contracting with sponsors
- Budget management
- Data Management: Case Report Forms build, REDCap database build and validation, data abstraction and entry
- Safety reporting
- Navigating the clinical trial review and approval process at MGB
- Training and onboarding new study staff
- Regulatory compliance checks: Preparing for internal and external audits, QI/QA audits, development of SOPs, Corrective and Preventive Action Plans (CAPA)
- Study coordinator services (pre-screening, screening, recruitment, study visit coordination, and data entry).
Francine J. Molay, MS
Rupali Ranade, MBBS
Qualitative and Mixed Methods Research
Qualitative and mixed methods research helps investigators study the “why” and “how” of questions related to healthcare and biomedicine. The DCR’s Qualitative and Mixed Methods Research (QMMR) Unit provides Consultations with investigators and research teams on qualitative and mixed methods research, including study design, data collection, data coding, analysis and interpretation, dissemination of results, and the development of research proposals and protocols. Please note that access to qualitative research software must be requested through MGB Research Information Computing and Science.
Elyse Park, PhD, MPH
Research Design
Our faculty support investigators in all stages of designing and planning studies involving health record data. We provide expert guidance on selecting appropriate study designs, defining research questions and hypotheses, identifying variables, choosing data collection methods, and addressing potential biases. We specialize in observational studies, pilot study development, IRB policy guidance, and feasibility trial design.
To start working with the DCR, download the analysis plan template, example, and example appendix before requesting your consultation.
To start working with the DCR, download the analysis plan template, example, and example appendix before requesting your consultation.
James B. Meigs, MD, MPH
Research Ethics
The mission of the Research Ethics Consultation Unit of the DCR is to assist investigators in considering and resolving ethical and IRB review issues and to work to improve the quality of IRB submissions. The Research Ethics Unit’s services include guidance in planning and conducting human subjects research, assistance addressing potential ethical issues, and discussion of practical solutions to potential ethical issues. Topics and examples of service include: the consent process and specific considerations, appropriate and effective recruitment plans, disclosure of findings or results, enrollment of vulnerable subjects, research involving digital health device or social media, and best practices in IRB applications, communications, and responses to review.
Survey Research
The Survey Research Unit provides expertise in all aspects of survey design, implementation, analysis and reporting. The Survey Research Unit provides consultations to leaders and investigators on survey design and development, sampling strategies, data collection and response rate enhancement, provides survey consultations and advice for all aspects of study design, execution and interpretation of survey data. Program faculty and staff have led hundreds of surveys in local, regional, national, and international contexts, including surveys with patients and health professionals in more than 20 different languages.
Esteban Barreto, PhD
TCRC: Nutrition Research
The Metabolism and Nutrition Research Unit within the TCRC is a fully featured research unit that collaborates with investigators on study design; assists investigators with grant preparation; boasts facilities to prepare standard and specialized research meals; collects and analyzes nutrition intake data; and performs metabolic assessments using a variety of modalities.
Jane Hubbard, MS
Translational Medicine
The Translational Medicine Group provides consulting support to assist investigators in bringing new novel compounds from bench to bedside, including clinical and pre-clinical protocol development and planning, IND and NDA assistance, and vendor identification.
Mason W. Freeman, MD
Virtual Drop-In Sessions for CRCs
Are you a clinical research coordinator? Do you have questions about MGB or MGH clinical research processes or systems, or whom to contact and next steps?
We are here to help. Come to the DCR’s Virtual Drop-In Sessions for CRCs! Get answers to all of your clinical research operations questions from experienced members of the DCR and chat with your fellow CRCs.
Drop-in sessions are hosted on MS Teams bi-weekly on Wednesdays from Noon to 1:00 PM.
Francine J. Molay, MS