If you are already familiar with SCORES, please go directly to the SCORES Request Form to begin. If you are new to SCORES, please read the information below.
SCORES can assist investigators and trainees in many aspects of their research, including:
- Development of research hypotheses
- Protocol development
- Design of clinical trials or observational studies
- Grant development
- Designing comparative effectiveness/outcomes studies using large administrative, claims, and clinical databases
- Database development
- Data storage and data management
- Planning for statistical analysis, sample size, and statistical power
- Manuscript writing and review response
Start with an Idea
SCORES would like to begin the process with a clear understanding of the objectives of your research idea. We would like you to develop a 1-page proposal presenting background for your research idea and population to be studied, your aim(s), and hypotheses. Please include a preliminary literature review. This will allow us to match you to a SCORES faculty member who can best assist you.
This short proposal will, in turn, help SCORES set you up with a SCORES Mentor who can help you in developing your research and negotiating the research development process. For learners, it is best to vet your research idea through your clinical faculty mentor and collaborators before approaching SCORES.
Collaborating with a Biostatistician
In all cases, we ask that you meet with a biostatistician. They can educate you about the design and statistical analysis of the study, assist in finding data resources, and help with database development. They are collaborators and should be recognized with co-authorship and review any documents for publication before they are submitted. Please submit a request for collaboration with a biostatistician through this website, http://bit.ly/SSD/BiostatsSupport. You should bring your mentor and principal team members to the initial meeting with the SCORES biostatistician. If you are a DCI faculty affiliate, you will likely be connected with a DCI biostatistician.
If the research will involve the collection and/or analysis of data, the protocol must be reviewed and approved by the Duke Health Institutional Review Board (IRB). There are several SCORES mentors who serve in various capacities in Duke’s Human Research Protection Programs. These SCORES faculty and your SCORES mentor can help you navigate the IRB submission process. It is important that you have all your required CITI research training up to date.
Please note that if the investigator has an approved IRB, the statistician must be listed on the IRB to do analysis or access the data. If IRB approval is not needed, the statistician should have confirmation from DOCR or Duke IRB that the study has been deemed to be IRB-exempt. Questions pertaining to IRB requirements can be sent via email to DHTS eIRB.
Finding Funding & Research Development Assistance
The Surgery Research Development (SRD) team provides services to investigators to help ensure the submission of high quality grant applications. The SRD can assist you with pulling your proposal together for submission, finding funding, and finding others in the department with whom to collaborate.
The Surgery Office of Clinical Research (SoCR) was established to provide turn-key clinical trial support for the Department of Surgery principal investigators, trainees, clinical research coordinators, and study sponsors. The SoCR assists with protocol design, budget development, sponsor negotiations, site feasibility assessments, study operations, staffing support, database design and data integrity, regulatory document preparation, submission compliance, research practice training, clinical audit, and serves as a liaison with the contracts and finance offices as well as inter-departmental resources.
You can find additional resources at the Duke Office of Clinical Research (DOCR). DOCR provides support for personnel performing clinical research across the Duke organization. DOCR provides data analysts, programmers, and study coordinators on a percent effort basis. Services include REDCap database/survey build, data management/coding, DEDUCE queries, study coordination, chart abstractions, data entry, regulatory support, etc.
Things to be aware of:
- Please remember that SCORES members are not only here to help you with your research, but also conduct their own research and maintain their own clinical duties. It is important to engage SCORES early and allow for enough time before the deadline to effectively accomplish the work.
- SCORES staff and biostatisticians who spend a significant amount of time and effort supporting your research project should be considered as co-investigator(s) or co-author(s).
- When grants are developed using SCORES resources, staff as well as biostatisticians should be included in the grant’s budget to help support the program, and SCORES should be acknowledged in all manuscripts.
- Please keep SCORES informed of the submission and publication of all abstracts and manuscripts that are developed using SCORES resources.