RFA-DK-19-023: Type 1 Diabetes in Acute Pancreatitis Consortium – Data Coordinating Center (T1DAPC-DCC) (U01 Clinical Trial Optional)
Internal Deadline: Contact Office of Research if interested.
LOI: February 13, 2020
External Deadline: March 13, 2020
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Amount: $2.3 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: The applicant for the Data Coordinating Center (DCC) must have experience serving as the DCC for studies on complex, clinical conditions, like the occurrence of diabetes mellitus (DM) after or as a consequence of one or more episodes of acute pancreatitis.
The overriding objective of this research program is to undertake a prospective longitudinal observational clinical study to investigate the incidence, etiology and pathophysiology of diabetes following acute pancreatitis with a particular emphasis on the auto-immune processes that result in T1D. The incidence, time course, and relationship to pancreatitis severity, the roles of pancreatitis etiology, genetic and genomic risk factors, environmental and biological factors and potential biomarkers for the development of T1D are subjects of interest.
Through the acquisition of a cohort of well characterized patients monitored over time for diabetes onset and T1D-associated autoantibodies, and collected biospecimens (blood, saliva, urine, pancreatic and duodenal juice, stools and when feasible pancreatic tissue), the proposed clinical research consortium will provide the resources and collaborative opportunities necessary to identify the interrelationship between the exocrine and the endocrine pancreas in the development of post Pancreatitis Diabetes.
Role of the Data Coordinating Center
A DCC applicant must have experience serving as the DCC for studies on complex, clinical conditions and be able to perform the following tasks. Planning will occur and be completed during the first year, see NIDDK-Guidance for DCCs.
Document Development and Management
- Collaborate on the development of study documents such as protocol, informed consent form, and operating procedures manuals
- Develop regulatory required documents
- Develop statistical analysis plan
- Maintain version control of all study documents.
- Maintain a Trial Master File for all relevant documents to fulfill expectations/requirements of the Food and Drug Administration and/or corresponding regulatory agency, including required long-term storage of regulatory documents.
Data Management and Website Requirements
- Develop data collection forms
- Develop and implement a data management system that is fully regulatory compliant
- Be responsible for protecting patient confidentiality at all steps in the submission and analysis of the data and ensuring the technical integrity and security of the data management systems
- Develop and maintain a multifunctional website for electronic case report forms (CRFs) and trial management functions of the coordinating center and clinical sites that is fully regulatory compliant
- Implement processes for the receipt, storage, and validation of device data
- Develop internet-based on-line procedures for patient enrollment and randomization
- Implement a system for adverse event reporting and medical monitoring
- Implement a quality assurance program that includes training and certification of clinical site staff; monitoring protocol adherence; monitoring patient recruitment, enrollment, retention and visit completion; site visits; reporting of quality control data; validation of collected data; and assessment of central laboratory
- Develop a centralized biospecimen tracking and management system that integrates with operation of a central biobank or testing lab (as necessary), to oversee collection and transfer of biospecimens between CCs, central testing labs, and biobank
- Be responsible for ensuring the transfer of all data to the NIDDK central repositories in a standardized format and according to a timeline developed with the NIDDK
- Implement a system for supplies distribution and accountability. Implement a system for drug distribution and accountability (if applicable)
- Conduct statistical analyses for monitoring, manuscripts, abstracts, and ancillary studies
- Prepare reports of the results of the studies and coordinate manuscript preparation/publication and other means of study results dissemination for presentations and publications
- In accordance with the Consortia’s Ancillary Study policy, engage a broader set of investigators external to the immediate study group to provide opportunities to analyze the data and participate in the parent study by means of ancillary studies
- As approved by the Consortia’s Steering Committee, develop opportunities for local analysis of data by study investigators and other qualified researchers at their institutions, and investigators outside the study group (“disseminated data analysis”)
- Provide a central IRB for clinical sites and provide assistance to sites in obtaining and maintaining IRB coverage
- Be qualified by NIDDK to hold IDE/IND for investigational device/drug studies or provide regulatory guidance to the IDE/IND holder
- Prepare safety and other reports for regulatory submissions
- Develop procedures to require study investigators and others associated with the study to identify financial and other conflicts of interest on a routine basis, at least annually, and share this information with the NIDDK program staff
- Collaborate with NIDDK in the management of the Data and Safety Monitoring Board (DSMB)
- Prepare reports for DSMB review
- Conduct administrative and logistical support services for the Consortium Steering Committee and DSMB and also participate in all study committees and preparation of agendas/summaries for conference calls and meetings, including Consortium Steering Committee meetings expected to occur in person 2 times a year in the Washington DC/Baltimore metropolitan area or other suitable venue.
- Administer on behalf of the Consortia funds for the support of patient enrollment cost, study biobank, central laboratories and other Consortia activities approved by NIDDK
- Identify fixed and variable costs and establish procedures for negotiation of third party agreements or selection of subcontractors (i.e. clinical sites, clinical/investigational pharmacies, clinical/research laboratories, drug distribution centers, biospecimen repositories, etc.), and develop processes to efficiently administer and manage same throughout the project
- Contract with companies and suppliers to obtain supplies and services required for a study
Budgetary Requirements: The application budget for DCC operating costs must not exceed $750,000 in direct costs per year, and should accurately reflect needs. Additional budget can be requested as indicated in section IV.2, R&R or Modular Budget.
Visit our Institutionally Limited Submission webpage for updates and other announcements.