DOCR Services
The Duke Office of Clinical Research provides a wide range of services to the research community that cover the entire range of the study life cycle from study planning and start-up to study close-out. DOCR has a team of research professionals available to facilitate the research process to improve patient care. Information about these services including contact information can be found below.
Clinical Research System Support: DOCR provides support for major research systems at Duke, including Maestro Care/Epic, iRIS, OnCore, and Advarra eReg. Our Epic analyst team supports research-related functionality, while our study initiation team builds study calendars in OnCore. We also provide web-based training and at-the-elbow support for iRIS and Advarra eReg.
Central Administration for Clinical Research Units: DOCR manages 24 distinct Clinical Research Units (CRUs) across DUHS. All principal investigators and research staff work within a CRU or Oversight Organization, responsible for the integrity, financial accountability, regulatory compliance, quality, and academic productivity of clinical research studies. DOCR develops institutional policies to assist the review and approval process for clinical research projects and provides clinical research education for the research community.
To request DOCR services, please complete a request form.
Content from the Duke Office of Clinical Research is now live on myRESEARCHpath! Please look there for the most up-to-date information, as content related to clinical research will soon be removed from our website.
The central charge reviewers (QA and Regulatory Compliance Associates) review both professional and technical charges in Maestro Care to ensure that charges for research patients are routed correctly. Charge reviewers work closely with the study startup to keep billing grids current and with the clinical trials billing office at the PRMO to get bills sent out accurately and in a timely manner
Currently, over 50% of all Duke clinical research protocols that require charge adjudication are being reviewed by the central charge review team. Areas currently include Oncology, investigational device studies, and federally-funded studies.
Contact central charge review at docr-chargereview@dm.duke.edu for assistance or questions.
The DOCR Service Core supports two clinical research sites available for study teams to utilize for participant visits: the Duke Early Phase Research Unit and Research at Pickett Road. For more information, please contact us at ResearchatPickett_Requests@dm.duke.edu.
ClinicalTrials.gov is an online database of clinical research studies conducted in the US and around the world. Registering and reporting study results on ClinicalTrials.gov is encouraged to promote research transparency.
DOCR is the ClinicalTrials.gov system administrator for Duke. DOCR helps maintain compliance with federal regulations and policies and assists study teams with understanding requirements and entering information into the database.
Contact the DOCR ClinicalTrials.gov team at DOCR-CTgov@dm.duke.edu
Tip sheets are available here.
DOCR’s Data team is comprised of staff members who are trained in REDCap, data management, honest broker, and data entry, etc.
Look here for information about:
- REDCap: DOCR REDCap Website | REDCap database build and/or maintenance, survey build and distribution, support for REDCap database and/or survey built by the study team
- Data Management: Data cleaning, coding, merging, prepare data for analysis
- Honest Broker: Data management, De-identification of data, cleaning, de-identification, and validation services to investigators and teams working in, or outside of, PACE
- Data Entry: Assistance with entering data collected on paper
The DOCR Service Center is comprised of staff members who are CITI-trained and skilled in study conduct at Duke. Services include study coordination, chart abstractions, data entry, regulatory support, etc.
If you are interested in getting an estimate or requesting services, please email us at ResearchatPickett_Requests@dm.duke.edu or visit the DOCR Service Centers page.
Advarra eRegulatory Management System (eReg) is an electronic regulatory binder used to manage essential protocol and staff documentation. eReg features include:
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Part 11-compliant electronic signatures
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Remote monitoring
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Central, shared storage for common staff documents (CVs, CITI training)
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Participant-level document storage
DOCR provides support to maintain Part 11 system compliance and provides online training and at-the-elbow support for the system.
For more information, please visit the OnCore and eReg Support Page or contact oncore@duke.edu to submit a service now ticket to the support team.
DOCR's Grant Planning team offers a free one-hour operational review of grant proposal elements to help ensure efficient implementation at Duke and ease downstream processes such as protocol development.
DOCR Advisors will bring in a team of subject matter experts to review your plans for participant recruitment and enrollment, study staffing and budget requirements, data collection, storage, and analysis with an eye toward building your budget and human subjects sections.
A general review of significance, innovation, and research strategy sections is also provided to optimize the clarity and flow of the application. Recommendations for additional resources are also provided.
This review can occur at any grant planning stage and will be tailored to the resources and recommendations that are most useful to you. Any mechanisms of *research or career development grants are appropriate for this service.
To request grant planning services, email docr-grants@dm.duke.edu.
* For support in writing School of Medicine Center or Program grants, please contact the Duke Office of Research Development.
In addition to at-the-elbow support for users in iRIS, DOCR also partners with OASIS to maintain tipsheets, user training modules, CITI and iRIS training validation issues, and other support for clinical research staff.
The DOCR Maestro Care Research Analyst team is responsible for the creation and maintenance of Maestro Care tools utilized for research. An all-inclusive approach is taken to provide comprehensive Maestro Care support to the research community. Initial study builds such as research medications, Smart Sets, and Research Beacon Treatment Plans are among the services provided. Our team works closely with research end-users to troubleshoot system issues and optimize research workflows within Maestro Care.
A variety of recruitment-enhancing tools are also available through DOCR’s Maestro Care Research Analyst team. These recruitment tools include silent alerts, custom schedule or patient list columns, Reporting Workbench Reports, and MyChart Recruitment. Maestro Care recruitment consults can be scheduled to review recruitment goals and develop a customized plan to optimize recruitment via the electronic health record.
If you are interested in receiving an estimate for a customized Maestro Care recruitment plan, please fill out this REDCap form. You can also explore our offerings via the Maestro Care for Research flyer to explain more about our available services.
OnCore is a clinical trial management system used by the Duke Office of Clinical Research. It provides tools and support for managing clinical trials, including tracking subject visits, managing study status, and handling financials. The Duke Office of Clinical Research offers training and support for the use and administration of OnCore, helping researchers to effectively manage their clinical trials.
Duke University School of Medicine, in partnership with the Duke Clinical and Translational Science Institute (CTSI) and the Duke Office of Clinical Research (DOCR), has launched a new community-facing website about clinical research.
My Duke Research serves as a searchable directory of clinical studies and trials at Duke, offering a variety of filters to quickly find enrolling studies by location, health condition, keyword, and more. The new site also provides helpful information about clinical research, shares updates about current studies and research results, and highlights the connection between health research and community health.
For information about how to post your study to this website, please contact studyrecruitment@duke.edu.
The DOCR Research Program Leader Resource provides assistance with program- or project-level management and support. Individual RPLs can be enlisted to support program leadership and individual teams by working to develop plans and processes, facilitate communications, and coordinate stakeholders both internal and external. They will ensure that your project stays on schedule, within budget, and that goals are met.
Services available also include regulatory planning and support; large collaborative event planning for research projects, colloquiums, symposiums, and consortiums; digital communications support for research programs; strategic planning; and SOP development. Please contact docr.help@dm.duke.edu for more information.
DOCR provides Spanish translation services for research-related documents for a fee. We can also provide in-person Spanish interpretation for research visits. For more information, please contact us at: ResearchatPickett_Requests@dm.duke.edu.
This free consultation service is open to all researchers and study teams who are beginning a new study or planning to conduct clinical research at Duke.
During this one-hour meeting, your DOCR Advisor will review with you the operational aspects of your research plan and provide recommendations and resource connections to increase the efficiency of study approval, start-up, and implementation.
A review of study documentation in advance of the meeting helps our expert staff identify potential pitfalls and opportunities.
Conversations are tailored to the needs of your study and your team, but typically cover:
- Study design
- Staffing needs
- Management of regulatory requirements
- Study implementation
- Data accrual, management, and analysis plans
To request a Study Planning meeting email docr-studyplanning@dm.duke.edu.
The Study Startup team is responsible for ensuring that all new studies have what they need in OnCore and Maestro Care prior to receiving institutional approval. They review all studies submitted to the DUHS IRB, build calendars in OnCore, perform coverage analysis for studies with DUHS billing, conduct study initiation meetings with study teams to review the calendar/coverage analysis content, and coordinate the Maestro Care build process. They also handle calendar amendment requests and provide end-user support.
For more information about our study initiation meetings, please contact docr-startup@dm.duke.edu.
DOCR training and communication services are intended to keep clinical research staff informed and provide opportunities to grow clinical research skills. The DOCR team has experienced instructional designers, website administrators, trainers, and communications professionals who provide these services. We provide instructor-led and eLearning courses, support and management of required training for clinical research teams, website administration, and communications about relevant changes and issues in clinical research.
Services include:
- Development and management of instructor-led and eLearning courses
- Bi-Weekly Research Wednesday training sessions
- The Research Professionals Network (RPN)
- Bi-Weekly Clinical Research Update Newsletter
- Support for CITI Good Clinical Practice training requirements
- DOCR and RPN listserv management
Contact docr-training@dm.duke.edu with questions.
The Workforce Engagement and Resilience team created and manages the competency-based framework for clinical research jobs at Duke. This framework is used as a foundation to help managers select titles for new positions, onboard new employees, set goals for professional development, and provide career advancement opportunities.
Services/Initiatives Include:
- Title Picker for hiring into clinical research job codes
- Onboarding Learning Plan templates for clinical research roles
- Onboarding consultations for managers of clinical research staff
- RPN+ New Hire Cohort Mentoring Program and Foundational Topic Series
- Training organized by competency for clinical research personnel
- Engagement, Recruitment, and Retention Certificate Program
- Tier Advancement processes administration
- Guidance, tools, and training for Tier Advancement
Workforce Engagement and Resilience (WE-R) Page
Contact wer-jobs@dm.duke.edu with questions.
Free services are provided through the Participant and Clinical Interactions Core, which is run by DOCR, with support from the Duke CTSA grant [UL1TR002553], an initiative led by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health. Please be sure to cite this valuable resource in your publications.