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Alcoholic Hepatitis Clinical and Translational Network – Late Phase Clinical Trials and Observational Studies (Collaborative U01)
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to continue support of the previously funded program on “Translational Research in Alcoholic Hepatitis” to accelerate the discovery and validation of new diagnostic and treatment options for patients with Alcoholic Hepatitis (AH). This initiative, via a set of five FOAs, aims to enhance and consolidate the existing program into “AH Clinical and Translational Network”, hereafter termed “AH Network”. This consolidated program will consist of 1) Clinical component, 2) Data Coordinating Center, 3) Translational component, and 4) Basic and pre-clinical component.
Through this FOA, applications are sought to conduct investigator-initiated collaborative late phase clinical trials and observational studies in patients with AH under the U01 Collaborative Cooperative Agreements funding mechanism.
Only one application per institution is allowed.
RFA-AA-18-003, U01 Research Project – Cooperative Agreements
RFA-AA-18-004, U24 Resource-Related Research Projects – Cooperative Agreements (Institutionally Limited)
RFA-AA-18-005, U01 Research Project – Cooperative Agreements (Institutionally Limited)
RFA-AA-18-006, UH2/UH3 Phase Innovation Awards Cooperative Agreement
- Duke Internal Deadline: September 6. 2017
- Letter of Intent (not required) Due Date(s): September 23, 2017
- Application Due Date(s): October 23, 2017
RFA-AA-18-002 Expiration Date October 24, 2017
This FOA supports linked applications. Multiple PDs/PIs are allowed on any single application. Because the FOA already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.
Individuals involved in NIH-funded clinical trials must meet the requirements for documented ICH-Good Clinical Practice (GCP) training. Documented means GCP training that provides a certification/documentation of completion indicating that the training requirement has been successfully completed.
Appropriate personnel are those individuals responsible for the design or conduct of the study, including all personnel of participating consortia and performance sites participating in the clinical trial.
The GCP training of choice must meet the GCP Principles of ICH E6.
Owing to the sponsor's restriction on the number of applications that may be submitted from Duke, anyone wishing to pursue nomination should submit the following materials as one PDF.
* A letter of support from dean or chair - 1 to 1.5 pages
* Project summary - 2 to 4 pages
* CV or Biosketch of project leader
Please submit internal materials through My Research Proposal. (Code ILN) https://www.grantinterface.com/Common/LogOn.aspx?eqs=ApVvmgXCk2Uj7AzWyDEJKQ2
Instructions for setting up your account and uploading internal applications can be found here: https://ors.duke.edu/sites/default/files/Applicant Instructions_FINAL.pdf