The Duke Office of Clinical Research (DOCR), housed within the Duke University School of Medicine, provides navigation, tools, and training to support the conduct of clinical research in which Duke serves as an investigative site. These services and tools are available for faculty, staff, students and trainees at Duke.
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 process of research with the ultimate goal of improving patient care. Information about these services including contact information can be found below.
To request DOCR services, please complete a request form.
Budget Development and Negotiations/Contracts
DOCR provides free consultation on budget development and negotiation, SPS entry, and fund code set up or closeout. In addition, if your study team or unit requires additional assistance above and beyond a brief consultation, our staff can provide support on a percent effort basis. DOCR also provides assistance in helping the research community navigate the contract process at Duke. If you have a contract that appears to be “stuck” in the process (whether with sponsor or Duke), we will be happy to help facilitate moving it through the system.
If you are interested in having DOCR personnel assist with your budget development and negotiation, please complete a request form. For general inquiries and consultation, please contact email@example.com.
Centralized Charge Review
The centralized charge reviewers (QA and Regulatory Compliance Associates) review both professional and technical encounters to ensure that charges route correctly. Charge reviewers work closely with the study initiation team keeping the grids current and correct and with the clinical trials billing office at the PRMO to get bills sent out accurately and timely.
Currently over 50% of all Duke clinical research protocols that require charge adjudication are being reviewed by the centralized charge review team with the goal of 100% review of all research protocols in the future. Units currently being reviewed by centralized charge review include: Adult Bone Marrow, Thoracic, Sarcoma, GI, Phase 1, Breast, GYN-Onc, Endocrine Melanoma, Brain Tumor, Urology, Rad Oncology and Cardio-Thoracic devices.
Contact centralized charge review at firstname.lastname@example.org for assistance or with questions.
ClinicalTrials.gov is a web registry of publicly and privately supported research studies conducted in the US and around the world. 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.
If you have questions, contact the DOCR ClinicalTrials.gov team DOCR-CTgov@dm.duke.edu
Look here for instructions on:
- How to Register a Study
- How to Maintain a Study Registration
- Reporting Results in ClinicalTrials.gov
- Frequently Asked Questions
DOCR’s Research Management Team is comprised of staff members who are CITI-trained and skilled in study conduct at Duke. We provide data analysts, programmers, and study coordinators on a percent effort basis. Services include REDCap database/survey build, data management/coding, study coordination, qualitative services, educational design, chart abstractions, data entry, regulatory support, etc. This is a great option for projects or departments that require a short-term commitment, less than 1 FTE for support, or a range of skills not usually found in a single job description.
If you are interested in getting an estimate or requesting services, please complete a request form. For questions or more information about the Research Management Team, please contact us at email@example.com.
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 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
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 with you 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 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 firstname.lastname@example.org.
* For support in writing School of Medicine Center or Program grants, please contact the Duke Office of Research Development.
Maestro Care for Research
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 build 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, and Reporting Workbench Reports. 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 email email@example.com. You can also view our Maestro Care for Research flyer to explain more about our available services.
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 firstname.lastname@example.org for more information.
Study Operations Planning
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 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 email@example.com.
A study initiation meeting may be held for those studies that require a Maestro Care billing calendar and order set, or Beacon build. In this meeting, we discuss appropriate billing designations and Maestro Care build needs. If a meeting is required, representatives from DOCR’s Start-up and MaestroCare Build teams will meet with study team members to discuss the protocol and identify needs for Maestro Care, including order set/Beacon build and a billing calendar to direct charges and aid with charge review. The study initiation meeting also provides a forum to discuss alignment with Duke and national clinical research policy, as well as educational and clinical research services within Duke. For more information about our study initiation meetings, please contact us at firstname.lastname@example.org.
Training and Communications
DOCR Training and Communications works to help you improve your clinical research skills and work performance. This group is comprised of an experienced staff of instructional designers, website administrators, trainers, and communications professionals. We provide instructor-led and web-based training courses, support and management of required training for researchers, website administration, and communications of changes and issues in research.
Look here for Information about:
- Upcoming training classes, both instructor led and web based, including Maestro Care and OnCore
- Research Wednesdays
- The Research Professionals Network (RPN)
- Current and Past Editions of Newsletters
- Signing up for the DOCR and RPN listservs
The Duke Office of Clinical Research initiatives and projects can be found here.
Workforce Resilience and Engagement
The Workforce Resilience and Engagement is tasked with simplifying the number of job classifications utilized in Clinical Research and developing a competency-based approach to professionalize the clinical research professionals working environment.
Look here for information about:
- Project overview
- Directions to create a Job
- Tier advancement processes and tools