Resources for Duke Investigators

CTSI provides support to investigators and research teams through all aspects of the research continuum, from preclinical research to randomized clinical trials to point-of-care and community-based studies.

Many of these are supported through the Duke Clinical & Translational Science Award (CTSA).

Please remember that research supported by CTSA-funded resources must cite the Duke CTSA grant number (UL1TR001117) and be submitted to PubMed Central. 

Biobanking / Biorepository

Biobanking / Biorepository

Biobanking resources at Duke include shared resources specializing in biological solid and liquid sample handling, external commercial biobanking services, referral to available biospecimen collections, and biobanking education for researchers. The Duke Biobank provides consultation in:

  • Biobank planning, operations and data management
  • Biobanking best practices
  • Sustainability and specimen use planning
  • Industry sponsored research utilizing biospecimens

Duke Biobank manages a searchable index of biospecimens that may be available for use. The Duke Biobank is leading the implementation of the institution-wide biospecimen information management system.

  • Index of Biospecimens is a catalog of existing clinical research biological samples at Duke that are available for research projects.
  • LabVantage® Biobanking Information Management System will serve as Duke’s biobanking information management system.

Biobanks at Duke

Biofluids Shared Resource — (BSR) The BSR (previously known as the DNA bank) holds approximately 500,000 human biological samples and offers biobanking services, including blood fractionation, DNA and RNA extraction, storage and tracking. Consider a meeting with the BSR Study Implementation Group to consult about how to best serve your biobanking needs.

Kathleen Price Bryan Brain Bank and Biorepository  — The Brain Bank provides Duke researchers and academic and industry collaborators access to a collection of over 1,000 frozen and formalin preserved brains, 400 cerebral spinal fluid biospecimens with accompanying clinical, pathology, and neurocognitive data, and over 6,200 DNA samples.

Duke Human Heart Repository (DHHR) — The DHHR has over 30,000  human heart samples from over 550 donors for research and is a resource for assay development, target identification, and sponsored research.

Biospecimen Repository and Processing Core — (BRPC) is Duke’s central tissue procurement core in the Department of Pathology and is supported by the Duke School of Medicine and the Duke Cancer Institute. BRPC provides services that include patient identification, informed consent, specimen collection, processing and annotation of specimens, storage and specimen distribution.

The MURDOCK Study — This community registry and biorepository in Kannapolis is a longitudinal community-based registry, managed by CTSI, that has banked more than 415,000 biospecimens (including plasma, serum, whole blood, PAXGene® RNA, buffy coat, and urine) from over 12,000 study participants who have contributed self-reported data during enrollment and follow-up timepoints.

Budget Planning and Feasibility

Clinical Trials Resources

Duke Clinical Research Institute (DCRI)

Duke Clinical Research Institute (DCRI) is an academic-based coordinating center for multisite clinical trials, with expert thought leaders across disciplines. The DCRI performs outcomes, comparative effectiveness, and quality of life research. Services include study design, clinical operations, statistics, data management, regulatory support, safety surveillance, and clinical event classification.

Duke Early Phase Clinical Research

The Duke Early Phase Clinical Research Unit is a 30-bed, hospital-based Phase I research unit that conducts early phase studies that require constant patient surveillance. Early Phase  has an embedded anesthesiology suite for pharmacology studies, a registry of more than 4000 normal healthy volunteers and a recruitment service.

Researchers seeking clinical expertise and operational capacity to translate preclinical discoveries, new technologies, or device prototypes to humans can collaborate with Duke Early Phase Clinical Research to conduct a broad range of early phase, proof-of-concept, and first-in-human studies.

We partner with pharmaceutical, biotech, medical device, government agencies, foundations, technology companies, and academic centers to accelerate the availability of therapies, diagnostics, technologies, and medical devices to patients.

Our thought leaders optimize clinical trial design to increase operational efficiencies while maintaining regulatory compliance.

At a Glance:

  • 34-bed unit, one of the largest academic early phase units in the country
  • 50+ personnel experienced in early phase clinical research
  • Data analytics/reporting (including PK/PD modeling) that meets FDA reporting standards 
  • Large healthy and patient volunteer registry 

Collaborate with Early Phase:

Contact Juan Martinez at jaun.martinez@duke.edu or (919) 384-6418 with details about your research question and needs. You will receive a response within 24 hours.

Learn more online

Duke Office of Clinical Research (DOCR)

Duke Office of Clinical Research  (DOCR) supports the clinical research units (CRUs) that provides tools, training, and resources for site-based research at Duke. DOCR coordinates a research management team of research coordinators, project managers, and data analysts available through a fee-for-service model to support research projects that need part-time support.

Office of Research Informatics (ORI)

Office of Research Informatics (ORI) provides services to support academic research including information technology (vended system selection, custom software development, technical and user support, system integration), academic informatics, research faculty and curriculum development, and data stewardship.

ResearchMatch

ResearchMatch is a volunteer registry service that matches researchers nationwide with volunteers interested in participating in clinical research studies. Duke is one of more than 70 institutions participating in ResearchMatch.

ClinicalTrials.gov

Registration in ClinicalTrials.gov is REQUIRED for all “Qualifying Trials”, meaning clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1. A ClinicalTrials.gov NCT# must be provided to DOCR for all “Qualifying Trials” before institutional study approval is granted. For more information regarding qualifying trial determination, please click here or contact DOCR.Help@dm.duke.edu.

Communication and Dissemination

Manuscript Matching

Larger publishing houses often offer manuscript matching using a free algorithm model to identify the journal that might be the most appropriate for your research. Elsevier, Thompson Reuters, and Springer all offer this service.

The Agency for Healthcare Research and Quality also offers guidance through an online dissemination planning tool.

 

* Please remember that research supported by CTSA-funded resources must cite the Duke CTSA grant number (UL1TR001117) and be submitted to PubMed Central. 

General Communications

Communications Resources from the School of Medicine include logos, branding guidelines, and primary communication contacts.

Duke Print Management provides graphic design and printing services.

PhD Posters provides overnight printing of posters, and on-campus delivery.

Duke Learning and Organization Development offers a variety of courses, including PowerPoint®, Introduction to Professional Communication, Essential Presentation Skills, and Effective Written Communication.

Registration in ClinicalTrials.gov (link is external) is REQUIRED for all “Qualifying Trials”, meaning clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1. A ClinicalTrials.gov NCT# must be provided to DOCR for all “Qualifying Trials” before institutional study approval is granted. For more information regarding qualifying trial determination, please click here or contact DOCR.Help@dm.duke.edu (link sends e-mail).

  

 

Data Management Tools

CTSI Biostatistics Group

Biostatistics Group –provides expertise in statistical methodology. The Core includes a team of statistical faculty and staff with diverse and extensive experience conducting a broad range of research projects.

DEDUCE (Duke Enterprise Data Unified Content Explorer)

DEDUCE is a tool available to Duke faculty that enables the quantification of potential study subjects at Duke based on varying inclusion and exclusion criteria available in clinical records. It can be used to estimate potential recruitment.

DEDUCE™ is a self-service, web-based clinical research and quality improvement query tool with an intuitive, user-friendly interface.  It allows for flexible searching of data hierarchies compiled through years of patient care. It allows users with no previous database experience to identify cohorts of patients and extract data while maintaining patient privacy.

The DEDUCE™ data set currently covers over 3.4 million patients, spanning 37 years.  The data are refreshed daily with updates provided from a combination of current Epic Clarity and legacy EDW data elements. The data include more than 1.6 billion lab results crossing over 10,000+ socio-economic data elements based on U.S. census data.

DEDUCE includes clinical information systems serving the Duke University Health System and includes tools for:

  • Real-time tracking of potential research participants (DISCERN)
  • Geographic mapping of patients (DEDUCE Geo)
  • Text analytics search of radiology and pathology reports

NOTE: Users must request a DEDUCE account and be approved by their supervisor.

Click here to learn about requesting a DEDUCE account.

 

REDCap

REDCap is a secure, web-based application for building and managing online surveys and databases. Surveys or databases can be created directly in REDCap through a web-based project designer, or built in Microsoft Excel® and uploaded into REDCap.

The CTSI also supports Retrieve Form for Data Capture (RFD), an open-source standard for REDCap.

Retrieve Form for Data Capture

Retrieve Form for Data Capture - This open-source software, hosted on App Orchard, transfers electronic health data across REDCap and Epic, reduces data collection time, and prevents manual transcription errors, allowing researchers and their teams to conduct more efficient and high-impact clinical research.

Education and Training

MentorDuke Mobile App

  • Mentor Duke
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MasterControl Online Training

MasterControl is a web-based quality management system (QMS). It is typically used as the master repository for all versions of SOPs and other documents, as well as for workflow and training management. MasterControl complies with FDA regulations (such as 21 CFR Part 11) and GMP standards. Use of MasterControl requires a license and ongoing maintenance fees.  Quick reference cards and training resources for Duke uses can be found here. 

Research Professional Network (PRN)

Research Professional Network (RPN) - Duke Office of Clinical Research (DOCR) hosts a 1 hour monthly professional network meetings to provide education and professional development opportunities. All meetings cover at least one pertinent topic and include time for networking with peers.

Graduate Medical Education

Graduate Medical Education (GME) and the Duke Office of Clinical Research (DOCR) offers a seminar series exploring foundational research concepts and practices. The series is comprised of 8 one-hour segments and is offered in September, October and November.

Research Wednesdays

 

The Duke Office of Clinical Research (DOCR) and the Medical Center Library & Archives have partnered to bring the Duke Clinical Research Community the “Research Wednesdays” series featuring important topics presented by subject matter experts in each field.

  • Research Wednesdays are held the 2nd and 4th Wednesdays of the month.
  • Unless otherwise posted, all presentations will take place in Duke North 2002.
  • No registrations is required.  Just bring your badge and sign in at the door.
  • Print your handouts ahead of the session from the Duke LMS.

View the upcoming schedule of presentations and recordings of past presentations (through LMS) on the DOCR website.

Collaborative Institutional Training Initiative (CITI)

All Duke Medicine clinical research personnel who participate in the conduct of research with human subjects (i.e. are responsible for the study design, data, or specimen collection or who contribute to the scientific development or execution of the study in a substantive, measurable way) need to fulfill the Collaborative Institutional Training Initiative (CITI) training requirements. In addition, all Duke Medicine staff involved in the review, approval, or oversight of research involving human subjects also need to complete this training.

Funding

Duke-Coulter Partnership

Duke-Coulter Partnership awards funds to accelerate translational research projects that address unmet clinical needs and lead to improvements in clinical practice. Approximately $700,000 is available per year for awards.

CTSI Pilot Program Funding

CTSI Pilot Program  – awards funding to support the development of novel methods and proof-of-concept evaluation of therapeutic agents, biomedical devices, diagnostics and other initiatives to improve health care. Awards range from vouchers to use shared resources on campus, to $500,000 awards for mature research with potential for commercialization.

MyResearchProposal

 

MyResearchProposal is a web-based tool used for streamlining the management of competitive grant application processes, nominations and other data collection mechanisms used by CTSI, the School of Medicine, School of Nursing and other institutes and departments across Duke. You can log on to the portalhere.

For more information regarding MyResearchProposal, contact Anita Grissom at anita.grissom@duke.edu or 919-668-4774.

Applicant instructions can be found here

Reviewer instructions can be found here.

For technical issues and password resets, contact myresearchproposal@duke.edu.

 

 

NCIDEA

The NCIDEA Grant Program awards grants up to $50,000 to technology-based businesses with the potential to become high-growth companies.

Licensing and Commercialization Services

Office of Licensing and Ventures

Office of Licensing and Ventures (OLV) coordinates patents, licensing and partnerships to advance Duke technologies to market.

Invention Disclosure - Duke investigators should disclose an idea, discovery or process to Duke by completing an Invention Disclosure Form (IDF). The IDF is a confidential, internal memo and will be used by OLV to assess patentability and potential commercial market. An IDF should be submitted to OLV 3 months before disclosing your idea to the public.

Duke Angel Network

Duke Angel Network (DAN) connects, supports and cultivates the Duke entrepreneurial community. In addition to providing capital, DAN actively matches Duke alumni expertise with portfolio companies.

Regulatory, Ethics and Compliance Resources

Animal Care & Use Program

Animal Care & Use Program oversees all research performed on animals at Duke.

Office of Regulatory Affairs and Quality

Office of Regulatory Affairs and Quality  provides regulatory guidance from preclinical requirements to first-in-human studies and beyond. The group serves as a no-cost resource to regulatory strategy development, IND/IDE preparation and maintenance, GCP/GLP/GMP requirements, and interfacing with regulatory authorities, such as the FDA. The regulatory affairs group also offers educational opportunities and internships. This office is part of the School of Medicine and is partially supported by the Duke CTSA grant.

For more information, contact Amanda Parrish, director of regulatory affairs and quality, at (919) 668-8772 or amanda.b.parrish@duke.edu.

Research Costing Compliance (RCC)

Research Costing Compliance (RCC) is a team of people who manage financial research compliance at Duke. RCC provides oversight and guidance to the university research community in the management of sponsored projects funding and the interpretation and communication of policy.

MasterControl

MasterControl is a web-based quality management system (QMS). It is typically used as the master repository for all versions of SOPs and other documents, as well as for workflow and training management. MasterControl complies with FDA regulations (such as 21 CFR Part 11) and GMP standards. Use of MasterControl requires a license and ongoing maintenance fees.  Quick reference cards and training resources for Duke uses can be found here. 

Research Administration Resources

Duke Office of Clinical Research (DOCR)

Duke Office of Clinical Research (DOCR) supports the clinical research units (CRUs) that provide tools, training, and resources for site-based research at Duke. DOCR coordinates a research management team of research coordinators, project managers, and data analysts available through a fee-for-service model to support research projects that need part-time support.

Occupational and Environmental Safety Office (includes biological and radiation safety)

 

Occupational and Environmental Safety Office (OESO) promotes a safe environment for the Duke community by 6 divisions that coordinate safety training and policies:

Office of Research Administration

Office of Research Administration (ORA) supports management of grant applications and award through databases for the administration research performed at Duke.

  • Sponsored Project Systems SPS is used to manage sponsored projects, including:  creating grant proposals, transmitting proposals through the approval process, and tracking general award information
  • Grants.Duke.edu enables electronic submission of grant proposals to federal sponsors, with data populated in SPS
  • Sponsored Effort System SES provides central grant offices the ability to update awarded effort information, and provides departmental users the ability to view active and pending effort for a specific person

Office of Research Support

Office of Research Support (ORS) oversees four areas for research conducted at Duke

Research Costing Compliance

Research Costing Compliance (RCC) is a team of people who manage financial research compliance at Duke. RCC provides oversight and guidance to the university research community in the management of sponsored projects funding and the interpretation and communication of policy.

Scholars@Duke

Scholars@Duke features the research, scholarship and activities of Duke faculty members and academic staff. A research networking system, Scholars@Duke displays web profiles that summarize a person's roles at Duke and displays their connections with colleagues.  

Research Facilities

Mousebase

Mousebase@Duke is a user-populated catalog of research mouse model strains used and maintained by Duke investigators, enabling investigators to access existing models instead of developing for increased research efficiency.

myRESEARCHnavigators

myRESEARCHnavigators is a team that can assist with identifying resources, finding answers to questions, and providing an overview of a process or requirement for research at Duke.

Flow Cytometry Facilities

MyResearchNavigators developed a comprehensive file of core facilities on campus that provide flow cytometry services. This Excel file includes detailed technical information including equipment type, capabilities, lasers, cell types, pricing, and any accreditations. It also includes the facility name and leadership for each unit.  The file is current through May 2015.

To request a copy of this file, please send an email to myresearchnavigators@duke.edu