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---+ Biostatistics Research

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---++ Current Federal Awards to Biostatistics Faculty

| *Principal Investigator* | *Grant No.* | *Funding Agency* | *Title* | *Total Project Award* |
| Qingxia CHEN, !PhD | R21 HL097334 | NHLBI | A New Approach to Correct Verification Bias Using Auxiliary Information |  428,277| |
| William DUPONT, !PhD (site PI) | !W81XWH-10-1-0993 | DOD | Mammographic Breast Density in a Cohort of Medically Underserved Women (subaward from MMC) |  389,435 | |
| William DUPONT, !PhD | R01 CA050468 | NCI | Epidemiology of Molecular Risk Factors for Breast Cancer |  3,102,691 | |
| William DUPONT, !PhD (site PI) | | Susan G. Komen Fndn | Development of an Individualized Risk Predictor Model for Women with Atypical Hyperplasia (subaward from Mayo Clinic) |  26,525 | |  
| William DUPONT, !PhD (site PI) | P50 CA116201 | NCI | Mayo Clinic Breast Cancer SPORE (subaward from Mayo Clinic) |  48,893 | |
| Chris FONNESBECK, !PhD (site PI) | R01 GM104247 | EEID | Linking models and policy: Using active adaptive management for optimal control of disease outbreaks |  391,639 | |
| Frank HARRELL, !PhD (site PI) | U01 HL1015462 | NHLBI | The ISCHEMIA Trial - DCC (subaward from Duke) |  1,215,372 | |
| Chun LI, !PhD | R01 HG004517 | NHGRI | Developing Statistical Methods for Disease Gene Discovery |  1,957,020 | |
| Jonathan SCHILDCROUT, !PhD | R01 HL094786 | NHLBI | Outcome Dependent Sampling Studies of Longitudinal Data: Design and Analysis |  794,528 | |
| Bryan SHEPHERD, !PhD | R01 AI093234 | NIAID | Statistical Methods for Ordinal Variables in HIV/AIDS Studies |  1,950,000 | | 
| Lily WANG, !PhD | R21 HG006037 | NHGRI | Integrative statistical models for pathway analysis of GWAS data |  445,160 | |
| Xi Chen, !PhD | R01 CA158472 | NCI | Integrative prediction models for metastasis risk in colon cancer |  2,322,322 | |
| Yu SHYR, !PhD | U01 CA163056 | NCI | Barrett's Esophagus Translational Research Network Coordinating Center |  2,027,070 | |
| | | | *TOTAL PROJECT AWARDS* |  *$15,098,933* | |

---++ Recent (last 6 mos.) Federal Grant Applications submitted by Biostatistics Faculty

| *Principal Investigator* | *Grant No.* | *Institute* | *Project Title* | *Earliest Start Date* | *Length of Project* | *Notes* |
| Fei YE, !PhD | 1R03 CA178680-01 | NCI | Development and Evaluation of Predication Models for Breast Cancer Prognosis |  04/01/2014  |  2 Yrs  | |
| Chun LI, !PhD | | sub from Medical College of Wisconsin |Statistical methods and tools for mutation discovery in cancer sequencing studies |  04/01/2014  |  2 Yrs  | |
| Chris SLAUGHTER, !PhD | 1R21 DK10198-01 | NIDDK | Unconditional tests and latent time series models for symptoms and reflux events |  04/01/2014  |  2 Yrs  | |
| Chun LI, !PhD | | sub from Dartmouth |Cataloguing the Human Atlas of Somatic Mutations-CHASM |  12/01/2013  |  5 Yrs  | |
| Matt SHOTWELL, !PhD | 1R01 HL118392-01A1 | NHLBI | Optimal design of challenge-response experiments in cardiac electrophysiology |  12/01/2013  |  5 Yrs  | |
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---+ PLAN to Submit your Grant Proposal

---++ NIH grant application due dates
   * [[http://grants.nih.gov/grants/funding/submissionschedule.htm][NIH application due dates]]
   * [[http://grants.nih.gov/grants/peer/guidelines_general/scoring_system_and_procedure.pdf][NIH Scoring System and Procedure]]
   * Cycle funding dates (earliest start dates) are at the bottom of this page
   * Vanderbilt requires internal submission to the Office of Sponsored Programs (OSP) *8 business days prior* to NIH deadline

---++ !StarBRITE Tools for Grant Writing (Including Dan Byrne's guidelines entitled, "How to Write A Successful NIH Grant Application)

   * [[https://starbrite.vanderbilt.edu/research/grantwriting.html][StarBrite Tools for Grant Writing]]
The following links may also be useful as you prepare to submit a grant proposal: 
   * [[http://www.vanderbilt.edu/osp][Office of Sponsored Programs]]
   * [[http://www.vanderbilt.edu/oor][Office of Research]]
   * [[http://grants.nih.gov/grants/funding/submissionschedule.htm][NIH Due Dates, Application forms and instructions, Review and Award Cycles]]
   * [[http://grants.nih.gov/grants/frequent_questions.htm][NIH FAQs]] *
   * Other useful sites [[http://era.nih.gov/][eRA Home Page]] [[http://www.grants.gov/][Grants.gov]] [[https://commons.era.nih.gov/commons/][eRA Commons]]
<strong><em>_NOTE: Your grant title cannot exceed 81 characters including spaces! _</em></strong>

---+ Biostatistics Proposal Development
Inform *Donna Bock*, Administrator, when you plan to submit a grant. This is helpful in planning work around NIH grant deadlines and in coordinating with the Vanderbilt Office of Sponsored Programs (OSP). Whether or not your research involves Human Subjects, it is important that you speak with our Research Nurse Specialist, *Peggy Schuyler*, early on in the development of your proposal so that she can begin to work through issues related to de-identified data and the hospital's Institutional Review Board; the final determination of Human vs Non-Human Subjects is to be made only by the IRB. Peggy is also available to review your proposal and offer advice/edits on language and structure.

Amie Stephens is responsible for coordinating *biosketch* submissions for all grant proposals. She will ask that you customize your personal statement to fit the application and to tailor your publications to the new application.

---++ COEUS

COEUS is Vanderbilt's vehicle for proposal development and electronic submission to NIH via grants.gov. You may choose to attend COEUS Lite for PIs and Approvers, especially if you are a new investigator. You may register for COEUS Lite by logging into [[https://www.mc.vanderbilt.edu/gcm/rate/main.php][RATE]]. You will also find the entire COEUS manual and other aids at this site.

*Donna Bock* will work closely with you to assist in the preparation of your proposal through COEUS.

---+ Narrative Sections of a Grant Proposal

Submit the following narratives to Donna, each in a separate word file (to allow for minor edits/corrections) which will be converted to pdf and uploaded into COEUS, or alternatively, you may provide your documents in separate pdfs. The following Research Plan information is taken from the NIH description of Restructured Application changes (effective January 25, 1010). The Business Plan and other narrative descriptions are derived from the COEUS manual and is representative of typical proposals. _Your specific guidelines will trump these guidelines._
---++ THE RESEARCH PLAN - <span style="background-color: pink;">This section does not have to be provided before submission to OSP and may be uploaded/revised up until submission to grants.gov</span>
---+++ 1. Introduction to Application (Resubmission or Revision applications only)
   * May not exceed one page for Resubmission (unless R25 which is three)
   * May not exceed one page for Revision
---+++ 2. Specific Aims
   * Always required
   * One page is recommended
---+++ 3. Research Strategy
   * Start each section with the appropriate section heading.
   * Cite published experimental details in the Research Strategy section and provide the full refernce in the Biobiography
   * cannot exceed <span style="background-color: yellow;">12 pages for an R01 or 6 pages for an R21</span>
---++++ (a) Significance
   * Explain the importance of the problem or critical barrier to progress in the field that the proposal addresses
   * Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more braod fields
   * Describe how the concepts, methods, technologies...that drive this field will be changed if the proposal aims are achieved
---++++ (b) Innovation
   * Explain how the application challenges and seeks to shift current reserach or clinical practice paradigms
   * Describe any novel theoretical concepts, approaches or methodologies..., and any advanage over existing methodologies...
   * Explain any refinements, improvements or new application of theoretical concepts, approaches or methodologies...
---++++ (c) Approach
   * Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project
   * Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims
   * If the project is in early stages of development, describe any strategy to establish feasibility...
   * *Preliminary Studies* for new applications and *Progress Report* for Renewal and Revision Applications should be included within the Approach section of the Research Strategy
---+++ Appendix
   * Maximum of 10 PDF attachments allowed
   * A summary sheet listing all of the items included in the Appendix is encouraged but not required
   * Do Not use the Appendix to circumvent the page limitations of the Research Plan
---+++ Protection of Human Subjects
   * _Always consult Peggy Schuyler, Research Nurse Specialist, who will facilitate IRB review_
   * [[https://irb.mis.vanderbilt.edu/pls/htmldb/f?p=106:20][Discovr-E web site]]
   * If "YES" to Human Subjects, you must include 
      * Inclusion of Women and Minorities
      * Targeted/Planned Enrollment
      * Inclusion of Children
      * Clinical Trials Waiver form where applicable
   * Clinical Trials Billing Compliance [[https://webapp.mis.vanderbilt.edu/factr/home.jsp][FACTr web site]]
---+++ Bibliography
   * Provide a bibliography of references cited in the Research Plan
   * No page limitation
---+++ Letters of Support
---+++ Less commonly used Narratives include:
   * Introduction (for resubmissions and revisions only)
   * Inclusion Enrollment Report (Clinical research, renewals & revisions)
   * Progress Report Publication List (renewals)
   * Vertebrate Animals
   * Select Agent Research
   * Multiple-PI Leadership Plan
   * Consortium/Contractual Arrangements (Financial arrangements with subaward institutions)
   * Data Resource Sharing Plan
---+++ Cover Letter
   * Applicants are encouraged to submit a cover letter (required for resubmissions)
   * May request assignment/referral to a particular Scientific Review Group

---++ THE BUSINESS PLAN - <span style="background-color: pink;">This section is required before submission to OSP for review/approval</span>
---+++ Project Summary, aka Abstract
   * Informative to others working in related fields, understandable to scientific or technically literate lay reader
   * Do not describe past accomplishments
   * Do not use first person
   * This section must be no longer than <span style="background-color: yellow;">30 lines of text</span>
---+++ Narrative (Relevance/Public Health Statement)
   * Describe the relevance of this research to public health
   * No more than <span style="background-color: yellow;">2 or 3 sentences</span>
   * Understandable to the general, lay reader
---+++ Facilities and Other Resources (EnvirResource)
   * Describe how the scientific environment will contribute to the probability of success of the project
   * Unique features of the environment
   * For Early Stage Investigators, the institutional investment in the success of the investigator (e.g. resources, classes, etc.)
---+++ Equipment
   * List major items of equipment available for this project and pertinent capabilities
---+++ Budget Justification
   * Detailed Budget Justification 
      * non-modular budget only
      * Detail all expense, personnel and non-personnel, with the purpose for each category of expense
   * Personnel Justification 
      * modular budget only
      * do not detail non-salary expense
      * Include all personnel, names, number of calendar months devoted to the project
   * Narrative Justification 
      * modular budget only
      * Describe variations from year to year _or changing number of modules_
   * Consortium Justification 
      * subawards only
_Note: Modular Budget submissions require Personnel Justification always and Narrative Justification as needed; there is no need for non-personnel expense justification and should not be included_
---++ Developing Your Budget

TownHallNotes15Sept2017

__MORE TO COME...__ <plugin><setting> :eek:
Topic revision: r71 - 19 Sep 2017, BryanShepherd
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