COVID-19 Research Resources
A curated list of research resources around guidelines, policies, and procedures related to COVID-19, drawn from Harvard University, affiliated academic healthcare centers, and government funding agencies

Access the resources of four clinical research centers. Connector

HC Connector Sites

Beth Israel Deaconess Medical Center

The Harvard Catalyst Connector (HC Connector) at Beth Israel Deaconess Medical Center (BIDMC) provides a wide array of services and facilities to investigators, including: bed and board; routine and specialized nursing care; routine and specialized nutrition services; research coordination services; assistance with specimen collection, measurement and long term sample storage; and outpatient interview rooms, examination rooms, and specialty testing labs. Research support may be provided within our research unit or by our staff in other locations in the hospital.

The HC Connector at BIDMC is located on the East Campus of the Beth Israel Deaconess Medical Center on the eighth floors of the Gryzmish and Feldberg buildings. The CRC provides space for inpatient, outpatient, laboratory, and administrative support activities.

The inpatient unit consists of eight beds in two double rooms and four single rooms. All have private restrooms, and one has a private shower.

The outpatient area consists of 12 rooms. Of these, two are general purpose outpatient rooms with beds and private bathrooms, one is an examination/minor procedure room, and one is designated as an interview room. Other rooms on the outpatient wing include a DXA room, a room equipped for neurological testing, dental studies, transcranial magnetic stimulation studies, and a syncope and falls-in-the-elderly laboratory.

The sample processing laboratory service processes samples for analysis at various laboratories, including the investigator's own lab if requested. Point of care testing is done under the hospital's CLIA certification. The laboratory is an access-restricted area where all samples are tracked to maintain chain of custody. Samples are stored at room temperature or in a monitored and alarmed refrigerator, -20 C freezer, or -80 C freezer short term. Access to long term use of -80 C freezers is available.

Access to administrative space includes a conference room, investigator's resource room (an office space for investigators to use while their participant's visit is occurring on the CRC), and use of the statistical programs on three computers located near the statistician's office.

Nursing at HC Connector at BIDMC provides comprehensive care, assessment, and teaching to research participants on the unit and throughout BIDMC as requested. Working collaboratively with the investigator, nurses develop standardized study-specific worksheets, orders, and lab processing instructions to enhance the consistency of data collection. Nurses also work in tandem with staff from other units where research is occurring, to provide a high quality experience for participants and investigators.

The HC Connector at BIDMC has an active Metabolism & Nutrition Research unit with expertise in body composition measurement, bone density, and metabolic testing. Located on the outpatient unit is a metabolic kitchen for preparation of nutrient-controlled meals as well as study-specific testing meals. The Metabolism & Nutrition Research unit also provides state-of-the-art nutrition computing facilities with programs for nutrient analysis, semi-quantitative food frequency analysis, and design and specification of research diets. Services include DXA, anthropometric measurement, indirect calorimetry, weighed meals, diet design, nutrient analysis, nutrition counseling, and education.

More information is available on the BIDMC Clinical Research Center page.

HC Connector at BIDMC Contacts:

CRC Director/Lead MRO
Janet Mullington, PhD
Email
617-667-0434
CRC Sample Processing Laboratory
617-667-8626
Administrative Director
Michelle Beck, MBA
Email
617-975-7600
Nurse Director
Mona Lauture, RN
Email
617-667-3354
Metabolism & Nutrition Research Director
Joanna Radziejowska, MS, RD, LDN
Email
617-667-3586
CRC Front Desk
617-667-3351

Boston Children's Hospital

The Harvard Catalyst Connector (HC Connector) at Boston Children's Hospital (BCH)/CTSU is an eight-bed unit centrally located within the main building of Boston Children's Hospital on Pavilion 6, and is organized to support the management of children participating in clinical research. The HC Connector at BCH offers over 5,000 square feet of ambulatory/outpatient space, and is adjacent to the inpatient research space, as well as part of the CAT/CR program located in an adjoining building. The outpatient unit has four private exam rooms, three consult rooms, and one special treatment testing room, as well as a metabolic kitchen. The research nurses of the HC Connector at BCH are experienced pediatric research RNs, CPR certified, proficient with IV insertion and maintenance, and experienced with timely collection and bedside processing of blood, urine, and other body samples.

The HC Connector at BCH's Metabolism & Nutrition Research unit has a research dietitian on staff who is experienced with developing/planning meals for research studies. The Center has its own metabolic kitchen to accommodate feeding studies and individual weighed meals. The research dietitians also perform anthropometry, bioelectric impedance analysis, indirect calorimetry, dietary analysis, air displacement plethysmography (BodPod), and nutrition education and/or counseling.

The HC Connector at BCH offers investigators the following research equipment: a Hologic Model-A Discovery Dual Energy X-ray Absorptiometry machine for measurement of bone density and/or body composition, a BIA for body composition evaluation, a portable ultrasound for measurement of bone density, and an Orthometrix model XCT 3000 peripheral quantitative computed tomography (pQCT) scanner to assess bone density.

In addition to the onsite processing laboratory, the HC Connector at BCH has both a processing and short-term storage laboratory (200 sq. ft) located next to and above the Children's Hospital Clinical Laboratories.

More information is available on the BCH Clinical Research Center page.

HC Connector at BCH Contacts:

Interim CRC Director
David Williams, MD
Email
617-355-8246
Administrative Director
Hernan Santana
Email
857-218-5628
Nurse Director
Lucinda Williams, MSN, RN, PNP, NE-BC
Email
857-218-4383
Metabolism & Nutrition Research Director
Leigh Keating, MS, RD
Email
617-732-7783
Medical Research Officer
Lise Nigrovic
Email
617-355-5862
CRC Front Desk
617-355-7861

Brigham and Women's Hospital

The Center for Clinical Investigation (CCI) is the home of Harvard Catalyst at Brigham and Women's Hospital. The CCI supports investigators and facilitates clinical research to accelerate discoveries for better health. Our mission is to maximize our investigators' ability to conduct clinical research as effectively and accurately as possible by providing a cost-effective option for commonly needed research services, as well as specialized support options, to meet the needs of investigators through the life cycle of a research protocol. Investigators that use CCI services are supported by National Institutes of Health (NIH), federal agencies, foundations, academic centers, hospital departments, and industry, and conduct protocols across a wide variety of therapeutic areas.

Our support to investigators spans the lifecycle of a protocol including Research Innovation Design and Analysis Services, Research Development and Execution Services, and Research Clinical Operations.

Research Innovation Design and Analysis

Early Stage Design and Innovation Services

Our integrated team of experienced and practical clinical research investigators, clinical operations staff, clinical project managers, biostatisticians and regulatory experts help investigators design research and write protocols that maximize data discovery from the study and reduce overall costs, without jeopardizing the integrity of primary and secondary objectives. Our research-experienced innovation team and interdisciplinary group of advisers conduct scientific and strategic evaluation of research projects for commercial viability. These services are focused on accelerating the transition of innovation in devices, diagnostics, therapeutics, and medical software from pre-clinical/prototype to first-in-human clinical trials.

Regulatory Affairs Services

CCI facilitates global regulatory affairs services for all stages of pharmaceutical, biologic, and medical device product development and lifecycle management, including consulting services for clinical trial applications, marketing applications, medical devices, medical writing, publishing and submissions, lifecycle management, preclinical and chemistry, manufacturing and controls consulting, agency interactions, strategic consulting, and intelligence and quality review.

Documenting pharmaceutical quality/chemistry, manufacturing, and controls; obtaining scientific advice and protocol assistance; following the FDA's Physician Labeling Rule; adhering to scientific guidelines implementing regulatory requirements.

Insight on FDA regulatory environments, smooth transitions from exploratory to confirmatory stages of investigational drugs, expedited submissions for possible acceleration of the developmental process, facilitated approval of applications to conduct clinical trials of new drugs, responses to regulatory body requests for information.

Biostatistics Services

Biostatisticians provide statistical collaboration by performing the analyses and writing the methods and results sections of manuscripts and answering any questions that arise in the editorial review process. Informal consultations are also available.

The CCI Biostatistics Consulting Service provides support for small, single center studies and multicenter international clinical studies. This support is available to the research community for statistical consulting on issues such as study design, data analysis for protocol development and grant applications, design support for pilot projects and grants, and data analysis for abstracts, manuscripts, and presentations. This service provides an alternative for investigators who traditionally may have resorted to finding independent biostatisticians through local resources like the Harvard School of Public Health.

Data Management Services

Our data management team works with investigators to evaluate concepts and practical methods to support planning, collection, storage, and dissemination of data in clinical research. Our team can help investigators deploy a data capture system, design case report forms (CRF), set-up and validate a study database, review and verify data, and provide data in a format ready for submission to regulatory authorities through final database lock.

Research Development and Execution

Clinical Project Management Services

The CCI has an experienced project management team that can be involved in all stages of the protocol life cycle. The project management team prepares study materials such as the protocol, case report forms, and informed consent documents. Our project managers are experienced in establishing the necessary documentation for IRB and/or Ethics Committee approval. The team is also instrumental in preparing and supporting protocols during initial meetings with the FDA and other regulatory bodies. They conduct pre-investigational visits to train site staff on the protocol, study materials, applicable regulations, and Good Clinical Practice. The team produces frequent reports and communications to keep investigators apprised of data accrual and quality on a site-by-site basis and keep the study team on track.

Research Coordination Services

The Research Coordinator Network (RCNet) provides investigators with a source for reliable and experienced research coordinators for clinical investigation. Coordinators are on hand to work simultaneously on a variety of protocols throughout the hospital, on a part- or full-time basis. Research coordinators are well-versed in the intricacies of IRB and FDA regulations, as well as sponsor-related documentation, and support protocol development and applications, subject recruitment and screening, and subject visit coordination and support, and data collection. RCNet staff are also familiar with the BWH facility and are prepared to assist new investigators in training new or inexperienced research staff.

Research Clinical Operations

Implementation Services

The CCI operations team works with investigators throughout the phases of a protocol, providing support on resource planning and pricing, ancillary support pricing, resource application guidance, Harvard Catalyst funding application guidance, site implementation and start-up guidance, scheduling support, and project management support. Our operations team is experienced in developing a deep understanding of protocol needs and crafting custom operational solutions.

Clinical Research Facilities

Inpatient

Dedicated inpatient research space embedded in the BWH campus is supported by research-experienced staff and can accommodate complex research requirements and ensure the safety of research subjects. Inpatient visits are supported by nurses, nurse practitioners, physician's assistants, and dieticians and direct research pharmacy support. Clinician staff are expert in carrying out sophisticated clinical research activities including clamps, infusions, and chemo-certified drug administration. The unit's location within BWH ensures the safety of patients should any serious adverse events occur. A simple processing laboratory is co-located with the unit and is available 24x7. Additional resources for study teams include meeting space, computers, and scheduling support.

Tower 9A includes six inpatient beds outfitted for telemetry monitoring for inpatient or specialized outpatient studies. Tower 9A units are available for inpatient studies as well as outpatient procedures that require more than 12 hours of intense nursing support.

Tower 9B boasts start-of-the-art technology to monitor subjects for studies requiring environmental standardization. It offers five suites outfitted for telemetry monitoring and designed to carry out studies in which nearly all environmental cues (e.g., environmental standardization of temperature, light, and outside stimuli) can be controlled. Each suite is constructed on an independent "floating" cement floor platform and is self-contained, soundproof, lightproof, and specifically designed with an anteroom for added temporal isolation. This facility also contains a highly sophisticated computer system to control and monitor many environmental factors (light, temperature, humidity, sound) and physiologic functions (blood, saliva, and urine sampling, EEG/sleep recording, neurobehavioral performance testing). This intensive physiological monitoring is often used in support of sleep research.

Outpatient

Our outpatient clinical research infrastructure provides cost-effective and convenient access to dedicated clinical-research space. Each of our three outpatient clinics is supported by our outpatient clinician team of phlebotomists, research nurses, nurse practitioners, physician's assistants, and dieticians. A simple processing laboratory is co-located with each clinic. Additional resources for study teams at each location include meeting space, computer workstations, and scheduling support.

Ambulatory Clinical Center (ACC) is located at 221 Longwood Ave. This clinic includes a waiting room, five patient-friendly examination rooms, phlebotomy chair, staff workstation area, a metabolic kitchen, patient dining room, conference area, and a specimen processing and storage laboratory. The ACC is ideal for minimally invasive, lower-risk studies.

Clinical Trial Center (CTC) is conveniently located in the heart of the BWH campus in Building A4, Elevator C off the Pike. This clinic houses a reception area, four exam rooms, phlebotomy chair, and a small laboratory for processing and storing specimens. Each exam room also functions as an infusion center, equipped to deliver controlled-rate intravenous infusions to patients with appropriate hemodynamic monitoring. This unit supports more complex, invasive research studies.

Clinical Trial Hub (CTH) is our newest facility in the Hale Building for Transformative Medicine. Opened in 2017, this clinic hosts a reception area, three exam rooms, a consult room, an infusion suite, and a small laboratory for processing and storing specimens. The infusion suite offers three bays equipped to deliver controlled-rate intravenous infusions to patients with appropriate hemodynamic monitoring. This clinic supports longer, complex research visits which often include infusions.

Sample Processing Laboratories
We offer on-site 24x7 simple processing support and preferred pricing access to diagnostic laboratories. On-site services for high quality, standardized routine processing are available at all of the CCI's research units. Our technicians perform specimen processing and shipping services, sample handling and processing, basic sample handling, labeling, serum separation, and blood sample centrifugation. The Lab also offers short-term specimen storage. Advanced services include PK study support, PBMC isolation and other specialized processing. For ancillary support, the CCI has negotiated preferred rates for investigators for ancillary support at partnership labs, including a commercial laboratory, BWH BRAC Labs, or BWH Stat Labs. (Analysis is performed, and results obtained through the partner labs.)

Walk-in Phlebotomy
CCI has established walk-in phlebotomy and processing services as a means to help study teams accelerate research activities. Walk-in phlebotomy and processing services are available at the Clinical Trials Hub (CTH – BTM3040, 60 Fenwood Rd) from 8:00am - 2:00pm, Monday through Friday. Walk-in services will be available to all current and future approved studies at the CCI.

Pediatric and Newborn Research Center
CCI collaborates with the BWH NICU to facilitate access to the BWH NICU's research footprint and cutting-edge neonatal care for studies in pediatric newborn medicine. Pediatric Newborn Medicine's NICU facility supports research for new ideas to improve neonatal care, including lung disease, neonatal neurology, and infant development. Recruitment and enrollment success is built upon a family-centered approach for research engagement including education of clinical staff and a personalized welcome and research orientation for all families with an infant admitted and eligible for potential research opportunities.

Radiology and Imaging
CCI collaboration facilitates investigator access to research imaging services, image scheduling, image acquisition, and image storage, at BWH.

Clinical Support Services

Highly experienced research clinicians offer clinical excellence across a variety of research protocols and methods.

Advanced Services (mid-level practitioners)
Nurse practitioners and physician's assistants collaborate with designated physicians and research team members, participate in the informed consent process, and provide education for patients considering enrollment or enrolled in a clinical trial. Mid-level practitioners provide exemplary patient care and work with investigators to define and perform clinical responsibilities in study visits including monitoring toxicities, assessing clinical responses, medical histories, and physical exams.

Nursing
Research-experienced nurses provide assessment and monitoring, infusions, IV placement, timed bloods, OGTTs, collaboration with BWH Investigational Drug Service, investigational drug administration, and patient education. Our nurses ensure participant safety and informed consent, integrity of protocol implementation, and accuracy of data collection and recording. Services are offered in both outpatient and inpatient units, and off-site as well.

Nutrition
Research dieticians provide education, training, and mentorship for investigators, students, and colleagues in areas of nutrition research methodology, study design, and implementation. Metabolic and nutritional services offered include anthropometry, bioelectrical impedance analysis, calorimetry, nutrient-controlled meal development and preparation, and food record analysis in support of both inpatient and outpatient studies.

IPM Circadian Technicians
Intensive Physiologic Monitoring (IPM) circadian (sleep) technicians are specifically trained for the high-intensity schedule of events in IPM protocols. Our technicians manage event schedules, utilize data collection systems, monitor and documents IPM participants throughout wake and sleep periods, collect, measure, and aliquot samples, and administer and monitor IPM participant completion of written assessments.

Phlebotomists and Laboratory Technicians
Laboratory technicians are experienced with many research techniques and activities and support visits by providing phlebotomy, automated BP/HR/O2 Sat/RR/ECG, specimen collection, and specimen basic processing services. All our technicians are International Air Transport Association (IATA) certified to ship biological specimens both domestically and internationally using any courier (e.g., FedEx, UPS). Lab techs are also experienced in working with many pharmaceutical companies and commercial testing labs.

Clinical Skills Training Center
Phlebotomy Training: Training for study staff who draw blood for clinical research studies and consists of three parts: a lecture on phlebotomy procedures, an observed phlebotomy on a simulation device, and practice venipuncture on a simulation device.

EKG/Vital Signs Course: Introduce the concepts of vital sign monitoring, anatomical landmarks, fundamental physiology of vital signs, EKG lead placements and safety guidelines. Vital signs included are temperature, pulse, respiration rate, and blood pressure. Underlying the demonstrations of taking vital signs and performing EKGs will be the concepts of standard precautions, patient identification, interpersonal communication, and accurate documentation.

Investigational Drug Services (IDS)
CCI staff facilitates coordination with IDS for pharmaceutical services and guidance in support of all research groups and investigators. IDS ensures delivery of high-quality pharmaceutical care, adhering to all laws and regulations while minimizing the risks associated with participation in an investigational drug trial. Services include drug handling and control, compliance with FDA, state, and hospital requirements, assistance in proper and accurate record keeping, establishment of randomization procedures and schemes, providing drug information and education, preparing sterile and non-sterile compounding, minimizing problems with the availability, preparation, and storage of study drugs, and promoting and assuring patient safety. Investigational drugs and study-related information are accessible 24 hours a day, seven days a week.

HC Connector at BWH Contacts:

CCI Director

Lindsey Baden, MD
Email
617-525-8418

CCI Associate Directors

Gail Adler, MD, PhD
Email
617-732-5666

Tanya Laidlaw, MD

Francisco Marty, MD
Email
617-525-8418

Daniel Pallin, MD, MPH
Email
617-525-6614

Peter Stone, MD

Jonathan Williams, MD, MSc

Administrative Director

Yemi Talabi-Oates, MBA
Email
617-732-7031

Research Innovation Design and Analysis Services Manager

Meredith Letendre

Research Development and Execution Services Manager

Shana Haynes-Harp BS, MSA, DHSC

Research Clinical Operations Manager

Hermine Osseni
Email
617-732-8007

Please email us with questions or to request access to resources.


Massachusetts General Hospital

The Harvard Catalyst Connector (HC Connector) at Massachusetts General Hospital (MGH) Inpatient Unit occupies ~6,500 sq. ft. on the 13th floor of the White building. There are five inpatient rooms, including a negative pressure room. In addition, one room is fully equipped for sleep studies with continuous EEG monitoring and blood drawing. The White 13 Clinical Research Center (CRC) is certified for IV conscious sedation.

The HC Connector at MGH Outpatient Unit consists of seven chairs. The inpatient rooms are also available for outpatient visits as needed, providing increased flexibility to accommodate longer, more complicated outpatient visits.

The HC Connector at MGH at the Charlestown Navy Yard (CNY) satellite is an outpatient-only unit and includes five chairs, an exercise treadmill, a metabolic kitchen, and a processing lab. CNY investigators have access to physiological monitoring equipment in the MRI bays. The CRC nurses are trained to perform arterial line blood draws in the MRI.

Nurse Practitioners are available to assist investigators as needed, i.e. signing orders for PhD investigators, and completing admissions, discharges, and monitoring of participants while on the unit. Nurses are available to perform off-unit visits and to support clinical research activity in other areas of the institution and in the community.

HC Connector at MGH Contacts:

CRC Director
David Nathan, MD
Email
617-726-2875
Associate CRC Director, Pediatrics
Madhusmita Misra, MD/MRO
Email
617-726-5790
Administrative Director
Lynelle Cortellini
Email
617-724-8420
Nurse Director
Kathryn Hall, MS, RNCS, ANP-BC
Email
617-726-3295
Director, Metabolism & Nutrition Research
Jane Hubbard, MS, RD, LDN, CBDT
Email
617-724-2830
CRC Front Desk
617-726-3294