Nih U01 Cooperative Agreement Mechanism

Since cooperation agreements are generally used for complex or targeted projects requiring close coordination of several grants or resources, you need to go through the FOA in depth and take into account the experience, intensity and degree of cooperation required to manage the cooperation agreement. NIAID U01 cooperation agreements for the implementation of clinical trials will not support high-risk clinical trials. Investigators seeking support for high-risk, safe clinical trials should contact the NIAID Clinical Trial Implementation (R01) Grant FOA (PAR-10-184). Note that the management of cooperation agreements may also differ slightly from the prices of the R-Series; for example, the transfer of funds not financed in cooperation agreements is not automatic and must be requested and justified. Cooperation agreements are generally awarded in response to applications (FRGs) that define the scope of scientific application, the activities required under the grant, specific peer evaluations, the nature of NIH staff`s participation in the awarding of the contract, as well as the specific responsibilities of NIH staff and the project manager/principal auditor (PD/PI) during the project period. No no. NiDDK does not need U34 if all planning activities can be completed by another mechanism. If you think you have completed all the planning necessary to carry out the clinical trial, you can apply for U01. However, the U01 application requires you to document that all necessary planning has been completed before submitting the U01 application. Recruitment of participants should be ready to begin as soon as a U01 award is awarded. Planning activities are not permitted under U01. The NIDDK experience shows that clinical trials require comprehensive administrative planning (for example. B, protocol closure, development manual, draft case report form, data management and study monitoring, etc.) before the recruitment of participants can begin.

These activities require considerable resources and staff; As a result, the administrative planning process usually begins after the study has been verified and funded by experts, and requires valuable time to complete the study. The mechanism for implementing national cooperation agreements for the implementation of U34 clinical trials will provide sufficient time and resources to complete the clinical activities and documentation required to meet NIDDK and regulatory requirements.