The CTSI Research Design and Analysis Program offers study design services for all proposed clinical and translational work, including grant applications. This is primarily a joint effort of the Department of Health Outcomes and Policy and the Department of Biostatistics, in association with the CTSI and the Departments of Epidemiology and Statistics.
We can help you set up your study in terms of refining your objectives into testable hypotheses, choosing a study design, providing you with a data analysis plan, and completing a sample size/power analysis. Although we do not get directly involved in data management, we work closely with you to ensure that your data will be compatible with the analytic needs of the study.
The primary goal of the CTSI Research Design and Analysis Program is research collaboration, not merely technical consultation. We welcome the opportunity to forge long-term collaborative arrangements with clinical and translational researchers where ultimately, we can contribute to research questions and develop new methodologies in your field. We are especially interested in helping promote research careers for young investigators.
- For grant submissions involving the CTSI, be sure to contact Dr. Shuster at least four weeks before your planned internal submission to the Division of Sponsored Research (usually six weeks before the due date at the agency). In exceptional circumstances, where this deadline cannot be met, we shall evaluate our participation on a case by case basis.
- Unless your project has faculty support from one of the following – Department of Biostatistics, Department of Epidemiology, Department of Statistics, or Department of Health Outcomes and Policy – you must contact Dr. Shuster prior to submitting your protocol to the CTSI for review and ultimate submission to the Scientific Advisory Committee. In some situations, this might be as simple as providing a biosketch and contact information for the individual who wrote the analytic research plan.
Charges for Study Design
With the exception of analyzing data from preliminary studies (which is charged under the rubric of Data Analysis), there are no upfront charges for study design.
If there is a substantial analytical component to the grant that involves biostatistical or epidemiological work, the PI’s grant must include appropriate funding for the data monitoring and analytical work. If the assigned analyst is not in one of the four participating departments, an NIH biosketch of the person assigned to do this work needs to be forwarded to Dr. Shuster. Where RDAP members are listed investigators on a grant, a support letter to the granting agency is available on request.
Role Assignment by FTE on the grant
- 30%+ PI or Co-PI
- 10%-29.9% Key Investigator or Co-PI
- 5%-9.9% Co-Investigator
- <5% Consultant
Budget Note: There are modest surcharges that apply to participation in grants that vary from department to department. Contact the analytic investigator for more details.
Dr. Jonathan Shuster
PO Box 100177