RFA-AA-18-004: Alcoholic Hepatitis Clinical and Translational Network – Data Coordinating Center (U24)
Internal Deadline: Contact the Office of Research if interested.
LOI: September 23, 2017, 5pm PDT
External Deadline: October 23, 2017, 5pm PDT
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 2
Anticipated Amount: $1.75 million
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI: Standard NIH eligibility requirements.
Through this FOA, applications are sought for establishing a central Data Coordinating Center (DCC) to support the AH Network designed to perform a range of studies including multi-center observational and interventional phase 2b clinical studies, early-phase pilot trials, translational and basic/pre-clinical research projects. The DCC will be integral to the efficient operation of the Network and will have primary responsibility for developing protocols, managing data, devising novel comparative study designs, providing sample size calculations and statistical advice, developing data forms and protocol tools, housing central biorepository, performing data analyses, coordinating and providing logistical support and overall study quality assurance.
The Data Coordinating Center serves as the Network data management center and biorepository, provides biostatistical and logistical support, coordinates various trans-Network activities as well as standardizes approaches, procedures and data formats to minimize resources/effort duplication.
Overall Role. The DCC is responsible for integrating the activities of individual clinical and laboratory study sites. The DCC will serve as the Network data management center and biorepository, provide biostatistical and logistical support, coordinate various trans-Network activities as well as standardize approaches, procedures and data formats to minimize resources/effort duplication.
Clinical studies. An independent DCC is critical to the integrity of the data collection and intervention delivery because of the need for central coordination of these activities in complex multi-site clinical studies. The DCC will contribute to the study design, ensure appropriate adverse event monitoring and reporting, manage data collection and quality, masking of staff to intervention assignment, and randomization, prepare interim data reports for the DSMB, conduct statistical analyses, and help with the dissemination of the results.
Biorepository. The DCC will establish and support a central storage facility for biospecimens including blood, urine, stool, saliva, and liver biopsy partnered with a carefully constructed database of relevant clinical, pathological, diagnostic, and demographic information. The DCC will create a searchable database for identifying and retrieving biospecimens, review requests for biospecimens and circulate these for approval, and also physically retrieve, prepare, and ship approved biospecimens to provide a complete life-cycle of biospecimen management within the AH Network, while ensuring their integrity and regulatory compliance.
Data Management and Analysis. The DCC will provide expert assistance in 1) designing data collection modules, operational procedure manuals and quality control systems of collaborative research projects, and in 2) bioinformatics and biostatistics for the analyses and integration of complex biological data from multiple experimental platforms and other sources.
Communication and Collaborations. The DCC will promote the sharing of the data, biospecimens, other materials, and resources. It will work with the Network site investigators to support collaborative project communications, including, but not limited to an internet-based communication platform/website where the protocols, amendments, manual of procedures, and other study communications are stored. The DCC will work with the Steering Committee to facilitate collaborations and enable the individual sites to integrate their projects/protocols so that the group can conduct joint protocols that provide adequate power for studies that require larger numbers than what is available at the individual participating sites.
Logistical support. The DCC will provide logistical support for daily functioning of the Network as well as for the Steering Committee, External Advisory Board and DSMB teleconferences/meetings; collect and document all Institutional Review Board (IRB) reports and communications; establish an account with clinicaltrials.gov and maintain listings for all Network clinical trials; work together with the Steering Committee on FDA-regulated documents including investigational new drug (IND) applications; create and maintain a public website for the AH Network; develop means to monitor/track research progress of individual projects, and assist the NIAAA project scientist in coordination of the Network.
Standardization. The DCC will provide leadership for identifying common elements in the individual site-specific projects, standardizing definitions, harmonizing data, and developing joint protocols. The DCC will work with the Network research site investigators to ensure that the consent language is appropriate for sharing both data and biospecimens.
Visit our Institutionally Limited Submission webpage for updates and other announcements.