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Guidelines for grant applications

QMC Guidelines for Grant Application with Data Coordinating Center (DCC)

If you are proposing a multi-center and/or multi-national study, the funding organization (typically NIH) will expect a Data Coordinating Center (DCC) to organize the study and monitor performance. For these applications, which typically are allowed extra pages (depending on the FOA), we offer the following services to assist in the grant proposal. For any other steps not listed, please contact us.

1.    Assistance in refining specific aims, particularly from statistical analysis perspectives

2.    Involvement in study design development

3.    Power/sample size calculation 

4.    Statistical analysis plans development and write up

5.    Participation in data management plans development

6.    Development of QA/QC plans

7.    Assistance in developing data safety monitoring plans

8.    Involvement in determining necessary personnel and efforts for the proposed works

9.    DCC: randomization process

10.  DCC: study document development process

11.  DCC: integration with PI and clinics and communication approaches  

To enable the QMC to produce a robust and quality application, please adhere to these timelines:

1.    At least 3 months before the submission deadline for new proposals – Proposals that start the planning early and allow time for internal peer review will likely be better quality

2.    At least 1.5 months before the submission deadline for resubmission, renewal, or recycled proposals

Percent efforts guidelines:

1.    The PI (or Director) of the Data Coordinating Center is expected to be a Ph.D.-level biostatistician with experience leading DCCs. A minimum average of 20% per year for the PI/Director and reasonable efforts for other required faculty statisticians

2.    Yearly average of at least 10% for faculty statisticians (in addition to the PI/Director) for projects with intensive statistical analysis (e.g., analysis for longitudinal data, large number of variables, missing data, cluster data, etc.) as specified by the DCC PI/Director 

3.    Efforts for statistical analysts should be included in addition to faculty statisticians; at least 25% effort for analysts for the year when data analysis (including DSMB reports) is conducted

4.    Similar levels for data management must be included to develop the central study database, develop the data entry approach, tailor the interactive voice/web response system (IVRS) system for patient randomization to treatment and, if necessary, monitor study drug inventory at clinical sites, etc.

5.    Typically, the DCC will have a separate budget from the main study, which will be developed by the PQHS financial administrators; there is an implicit understanding that indirects from the DCC budget will be returned to PQHS

6.    Any exceptions should be discussed with the QMC leadership and department chair

Please provide the following to allow the QMC to prepare the application. Other materials may also be required.

1.    Online request at QMC website

2.    Meeting(s) for new proposals to explain your research and proposal ideas and discuss the integration of the DCC with the clinical leadership and sites

3.    Final version of specific aims should be provided before we draft statistical analysis plans; a proposal with analysis plans that do not match specific aims will affect scores from reviewers 

4.    Pilot data that can be used to calculate effect sizes for power calculation; if pilot data are not available then need to provide effect sizes from the literature

5.    Discussions related to the logistics of the study, such as who will be authorized to request a patient treatment randomization and at what point in patient eligibility screening

6.    Work out the percent efforts with the study statistician to be consistent with DCC requirements and to pass on to the financial administration team at PQHS for paperwork and final budget

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