Information on Submitting a Multi-Center Clinical Study Cooperative Agreement (U01)
If you are seeking an exemption from the U34 requirement and wish to submit a multi-center clinical study cooperative agreement (U01) application (PAR-11-157), you should send a written request for permission to submit to the appropriate program director. Program staff will determine whether all the components of the U34 planning period have been accomplished and whether an exemption from the U34 is appropriate. Staff will also help the investigator understand whether the proposed clinical study addresses a high priority research area and meets programmatic needs including balance across research areas, whether it is appropriate to conduct using this mechanism, and whether funds might be available for the full clinical study.
You should contact the appropriate Program Director at least 6 weeks before the desired receipt date. However, to take the best advantage of the prior consultation process, contact should be initiated as soon as possible. Since this is a cooperative agreement, NIDDK will have substantive scientific involvement with the proposed project. NIDDK will need sufficient time to thoroughly consider the proposed study. It is the Institute’s experience that applications for multi-center clinical studies may be scientifically meritorious but often need further work before they are ready for submission. Allotting more than 6 weeks for the consultation process will allow time for revisions, should they need to be made.
Your written request for approval should be as succinct as possible. The details included in your letter may vary depending on the type of study planned (e.g., epidemiology study, drug trial, behavior intervention). Generally, the letter should include all of the following items:
- Date of Proposed Submission.
- Study title.
- Study PI, and other key investigators (attach biosketch(es))
- Primary institution.
- Specific aims
- Summary of study protocol, including flow diagram depicting study
- Summary of safety/risk issues
- Proposed start date, duration, and timeline of the clinical trial
- Proposed sample size including power calculation
- General statistical assumptions for the proposed study design and analysis
- Confirmed collaborating sites, including the demographics and availability of the study population at those sites. Include identification and a brief description of the Data Coordinating Center.
- Discussion of product/intervention to be evaluated and how it will be obtained, if applicable, including industry partner(s) and regulatory issues that have/need to be resolved.
- Detailed budget by year.
- Evidence that the U34 planning components have been completed.
Page last updated: April 05, 2013