(CLOSED) NIDDK Diabetes in Acute Pancreatitis Consortium - Data Coordinating Center RFA

Sponsor Name: 
NIH
Description of the Award: 

National Institute of Diabetes and Digestive and Kidney Diseases

Type 1 Diabetes in Acute Pancreatitis Consortium - Data Coordinating
Center (T1DAPC-DCC)

Internal Letter of Intent Receipt Date: January 30, 2020

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 longterm
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)

Statistical Analyses
◦ 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”)
Regulatory
◦ 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

Administrative
◦ 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

Sponsor LOI Deadline: 
Feb 13, 2020
Sponsor Final Deadline: 
Mar 13, 2020
OVPR Application or NOI Instructions: 

Interested applicants should submit a Letter of Intent which must follow the following format:

Margins: Use standard paper size (8 ½" x 11). Use 1/2 inch margins (top, bottom, left, and right) for all pages. No information should appear in the margins except page numbers.
Font: Use an Arial font size of 11.

Prospective applicants should upload their proposal in a single PDF file containing the following:

1. Descriptive title of proposed activity
2. Names of key personnel
3. Participating Institution(s)
4. Research Strategy (2 page maximum): The application should provide information on the DCC's experience with clinical
studies on complex clinical conditions, on multi-site and longitudinal data collection, and how this experience can be applied to the advanced clinical studies/trials that will be developed to pursue the
goals of the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC).

To be considered as a Penn State institutional nominee, please submit a notice of intent by the date provided directly below.
This limited submission is in downselect: 
Penn State may only submit a specific number of proposals to this funding opportunity. The number of NOIs received require that an internal competition take place, thus, a downselect process has commenced. No Penn State researchers may apply to this opportunity outside of this downselect process. To apply for this limited submission, please use this link:
OVPR Downselect Deadline: 
Thursday, January 30, 2020 - 12:00pm
Notes: 
Vernon Chinchilli (CoM)