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- How have BERD services changed?
BERD will provide easily-accessible consultations in biostatistics, epidemiology, research design, and analysis. BERD cannot furnish comprehensive statistical support for all translational research projects. For each project, adequate methodological support must be planned for and included in any funding request to a sponsor. The BERD consultations should be limited in scope and intended to help researchers understand the underlying methodological aspects of their research so that they can adequately plan their projects. In addition, BERD consultations are intended to help connect researchers with expert collaborators for additional or ongoing support.
- Am I eligible for services?
- To be eligible for services other than REDCap, you must be:
- a CCTST member
- full-time faculty from CCHMC, UC, or VAMC
- an Assistant, Associate, or Full Professor —or—
- a community member outside of the Academic Health Center
- To be eligible for REDCap, you must:
- For more details, see Eligibility Criteria.
- To be eligible for services other than REDCap, you must be:
- How do I apply for CCTST services?
- Create a Research Central request by clicking the Request Services button on the introduction page.
- For services other than REDCap, a CCTST consultant will contact you to schedule a meeting. If your consultant determines that you are eligible to apply for a voucher, which can offset some of the cost of CCTST services, he or she will provide you with a voucher application after this meeting. For more details, see Description of Voucher System.
- For REDCap, a specialist will contact you about setting-up a database.
- What services require a voucher?
For more details, see Description of Voucher System.
- Biostatistical Support
- Advanced Data Management
- Study Design
- Statistical Analysis
Research Central Policy
Effective April 1, 2015:
Access to biostatistical, study design and biomedical informatics resources within Research Central will be provided by application through a voucher system.
- Services covered by the voucher system: 1) Consultation on matters of study design and coordination with a methodologist exceeding one hour; 2) Consultation with a biostatistician to assist with the development of a statistical analysis plan for a grant application or for the analysis of existing data; 3) Execution of a statistical analysis plan and report writing; 4) Development and execution of a complex data management plan requiring data manipulation and quality assurance beyond the initial setup of a REDCap database, or requiring more advanced Clinical Data Management Systems (e.g., Medidata Rave); 5) Biomedical informatics support beyond the simple identification of patient cohorts in i2b2. Other services may be added to the list in the future, as needed and appropriate.
- Eligibility: Members of CCTST who are full-time (80% or greater FTE) faculty members from CCHMC, UC, or VAMC, including basic scientists, physicians, nurses, other health care faculty with advanced degrees (MD, PhD, MD-PhD or equivalent), and community members outside UC.
- Process: To be eligible for these services, you must be a CCTST member and submit a proposal using the Request for Consultation form in Research Central and include the services requested. Proposals should be in the form of a brief description of the project (1-page maximum) including the following items: a) hypothesis or research question, b) significance, c) background, d) a clear, itemized, but brief (1–2-sentence) description of services requested, and e) whether the request supports the submission of a grant application following an accepted extramural letter of intent, the resubmission of an unfunded grant application, or preliminary work for a future grant application, including agency and date. The CCTST may request additional documentation such as an IRB protocol, a letter of intent, review sheets for a previously unfunded grant application, etc.
- Review criteria: Applications will be reviewed in a timely fashion based on scientific merit, feasibility, and the specific plans for using the proposed project toward the goal of obtaining preliminary data for a grant application or other high-priority CCTST programs such as: 1) support for KL2, BIRCWH K12, K23, K08, and K01 Scholars or equivalent career development awardees focusing on clinical/translational research, and 2) support for projects funded through other CCTST mechanisms, including Methods and Processes Pilots and Community Health Grant programs.
- Vouchers will range in amount but generally will not exceed $2,000; they will be issued with an expiration date consistent with the scope of work. Any unused funds in the voucher will be returned to the pool of voucher funds available to other CCTST members. Investigators who receive a voucher that covers only a portion of the effort needed must provide evidence that they can complete the work (e.g., with matching departmental funds).
The most common reasons that voucher applications would be denied include:
- The applicant is not a CCTST full-time faculty member or CCTST community member
- Low scientific priority
- Absent or inadequate description of planned/future grant application or other “high” priority role for services provided, or
- Lack of departmental support to complete a project that requires more effort than can be covered by a voucher.
Projects that are not awarded a voucher may obtain access to the same resources through fee-for-service mechanisms, and the CCTST staff will facilitate linkage with the appropriate resources if a CCTST member so requests.
Guidelines for Accessing Research Support from CCTST
By submitting a request for support from the Center for Clinical and Translational Science and Training, investigators are able to access an array of personnel, tools and facilities to help with research.
- Biostatistical and study design consulting
- Data management tools, including REDCap and REDCap Survey
- Specialist data analytic tools
- Clinical data warehouse
- Clinical research ethics guidance
- Regulatory compliance assistance
- Pre-submission grant review
- Clinical Translational Research Center (CTRC) resources
- Participant recruitment resources
- Cincinnati Children’s Office for Clinical and Translational Research (OCTR) / UC Health Office of Clinical Research (OCR)
- Community partnerships
- Career development guidance and grant writing assistance
- Intramural funding opportunities
This list is illustrative only. CCTST personnel are experienced in a broad array of research and should be able to advise on the many questions or problems that arise, and identify a source for services that might be needed.
For assistance from the CCTST, complete a support request online at cctst.uc.edu/research. In the event that it is not possible to access the web site, users may email Rachael Shepler or telephone 513-636-9783.
Requirement for consultation
It is expected that all projects supported by CCTST will require a consultation with CCTST faculty. Faculty include specially trained researchers, methodologists, biostatisticians and bioinformaticians who work with investigators to develop a support plan that meets the needs of the individual project. This requirement for a consultation may be waived at the discretion of CCTST personnel.
What to expect at an initial consultation
Investigators should expect to meet with one of our experienced faculty, during which time we will conduct a project review and a comprehensive needs assessment. For faculty without significant research experience, including those who have not previously been a PI on an R01 or similar project, we request that they be accompanied by an experienced researcher who is acting as the mentor. At the end of the initial meeting, a plan of support will be developed. In many cases, support will be provided directly by CCTST personnel. However, in some cases investigators may be referred to a specialist within our extensive network.
After requesting support, CCTST personnel will be contacted within 3 business days. A consultation will usually be arranged within 5 business days.
Because there are always competing demands on support, investigators are expected to work with us to help meet their deadlines. Any timelines set for providing data, providing protocol drafts, or otherwise disseminating necessary information must be strictly adhered to, or a revised timeline will need to be established.
It remains the responsibility of the investigator to ensure that all activities move forward the timeline required for the project. The CCTST will endeavor to satisfy investigators’ needs, but may not be able to satisfy unrealistic deadlines.
Paying for support
The CCTST is able to offer some limited free support to investigators meeting certain criteria. A voucher for up to $2,000 for faculty or staff support per investigator may be provided at no charge for clinical and translational research that is not otherwise funded. After exhausting the voucher amount, investigators may apply for additional support up to a total of $4,000 and will be billed at current rates (for current rates, see cctst.uc.edu) after utilizing the total funded amount. For investigators with funded projects, CCTST staff will request a copy of the budget and budget justification in order to determine availability of support.
Investigators will be informed prior to incurring charges.
Review of projects at the CCTST T1 and T2 (TnT) meeting
Many projects have unique needs that cannot be met simply during consultancy or routine follow up. All projects may be discussed at TnT meetings to ascertain best approaches to meeting investigator needs and to identify additional opportunities for T1 and T2 translation. Projects brought to TnT will be discussed at biweekly meetings in some detail for problem solving. There may be some delay in obtaining feedback from TnT discussions because of the meeting schedule. TnT discussions will be documented in the same way as all project tracking and documentation.
Tracking and review of projects
It is the policy of CCTST to track all research projects through a database maintained by CCTST. Time and activities spent on a project are tracked, as are discussions held at the TnT meetings. On completion of projects, the record is archived.
User surveys and feedback
To meet reporting requirements and to maximize support, all investigators will be asked to provide feedback about the support they received from CCTST during the course of their project, and are expected to do so. For most, this will be a simple web-based survey. Some investigators will be asked to participate in a short interview. These surveys and interviews are conducted by the CCTST Evaluation Core.
In addition to formal evaluation, users are encouraged to provide any feedback, either good or bad. This can be done confidentially by contacting Jack Kues in the CCTST Evaluation Core. Grievances or concerns will initially be addressed by the CCTST Director and, if they remain unresolved, will be addressed by the CCTST Executive Committee.
Acknowledging support of the CCTST
The CCTST is funded in part by the National Institutes of Health Clinical and Translational Science Award (CTSA). All projects supported by CCTST that are being disseminated for public review must include the following text:
The project described was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health, under Award Number UL1TR000077. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
For more information, see NIH Funding Acknowledgment. Activities funded by other grants, such as use of REDCap, should additionally acknowledge the appropriate funding source.
Inclusion of CCTST personnel on publications
It is expected that investigators will follow the International Committee of Medical Journal Editors (ICMJE) guidelines for authorship. Authors should include those who i) generate at least part of the intellectual content (conception or design, data analysis and interpretation), ii) draft, review or critically revise the manuscript for important intellectual content, and iii) approve the final version to be published. Authors should be willing and able to defend the intellectual content, including data and conclusions, concede publicly any errors and, in the case of fraud, state publicly the nature and extent, and account for its occurrence. Personnel supporting projects should be provided an opportunity to participate in publications.
Investigators supported by the CCTST are required to archive all abstracts, posters and manuscripts with the CCTST.
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