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-08-58), please think through the items below in preparation for speaking with an NIDDK program director and/or submitting a written request for permission to submit. It is strongly recommended that you speak with a NIDDK program director prior to submitting your approval request letter.
The Institute will need sufficient time to determine if it will grant an exemption from the U34 requirement and accept the application. Therefore, please allow enough time before your planned receipt date to give the Institute a minimum of six weeks to determine whether it will approve your written request to submit your application.
Your written request for approval must be no longer than 5 pages. 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.
- Primary institution.
- Study objective or objectives.
- Scientific basis for and clinical significance of the proposed clinical trial.
- Potential impact on public health.
- Comparison with competitive therapies and degree of similarity with other clinical trials.
- Study design or flow diagram depicting study.
- Proposed start date, duration, and timeline of the clinical trial.
- Proposed sample size including power calculation.
- Feasibility to successfully undertake the study.
- Confirmed collaborating sites, including the demographics and availability of the study population at those sites.
- General statistical assumptions for the proposed study design and analysis.
- Product/intervention to be evaluated and how it will be obtained, if applicable.
- Industry partner, if applicable.
- Brief summary of risk information, e.g., available safety data, such as the product label, for the product. Also, include a description of regulatory issues that have/need to be resolved, e.g. have IND/need IND.
- Identification and brief description of the Data Coordinating Center.
- Detailed budget by year.
- Evidence that the U34 planning components have been completed.
Page last updated: March 26, 2010