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---+ Policies and Procedures for Grant Proposals

Biostatisticians in the Department of Biostatistics participate in grant development in various ways including:

   * assisting with the formation and operation of a proposal development team
   * assisting the investigators in refining study questions and measurement methods
   * developing study and experimental designs
   * writing statistical analysis plans
   * computing precision, power, and sample sizes necessary to achieve a given precision of estimation or a given power

When an investigator claims to need only a sample size calculation, we usually find that their fundamental study design requires improvement.  Unless we are provided sufficient time to participate in the study design, we do not work on proposals for which the investigator "only needs a sample size calculation."
---++ Investigators Served
We provide grant development assistance for proposals that are:

   * explicitly covered under the auspices of the !CTSA or Cancer Center Biostatistics Core Resources
   * multi-department proposals of major importance to the School that are initiated by the School of Medicine (not by a department of the School) 
   * developed by a research group that is participating in our [[CollaborationProcedures][collaboration cost-sharing plan]]
   * developed by other groups who we will charge by the hour (see ServicesOverview)
   * logical extensions (e.g., competing renewal) of a grant that is already funding a biostatistician who will work on the new proposal
   * research areas of special interest for a <nop>PhD faculty biostatistician


---++ FOR INVESTIGATORS

---++ Requirement of Advance Notice

Grant proposals require input from a number of experts. Teams assembled at least four months before submission generate the strongest grant proposals.  Optimally, team meetings should meet every three weeks to generate at least two major proposal revisions.  From the point of view of the biostatisticians, they will then have sufficient time to do their best work and thus, significantly enhance the likelihood of funding.  

We usually require two or more months advance notice when asked to provide assistance with proposals.  If not, we will provide assistance only if personnel are available and we will charge departments and divisions by the hour for this service.  Exceptions will be granted for cases involving resubmissions, renewals, or submissions of proposals that are substantially similar to previous grants in which the biostatisticians have fully participated.  

When there is insufficient time for one of our <noc>PhD or MS biostatisticians to work with you on a proposal, we will still provide free consultation during our daily [[Clinics][Biostatistics Clinics]]. Although you will not be able to name the consulting statistician as a Key Personnel on the proposal, you will receive valuable advice on how to avoid major design or analysis pitfalls.  On rare occasions, when the design is very simple, we can analyze simple pilot datasets or perform sample size calculations.
---++ Use of Biostatisticians' Names on Proposal
We do not allow an investigator to use the name of a <noc>PhD or MS biostatistician on a grant or contract proposal unless the biostatistician has fully participated in the development of the proposal from its inception and can vouch for the study design and analysis plan.
Donna Bock is grants manager for the Department of Biostatistics; she will work closely with you when preparing your proposal.  
---++ Prohibition of unauthorized change of Biostatistician's Names
We do not allow an investigator to change or to remove a biostatistician's name once it is officially listed on a grant proposal unless special permission is obtained from the Chairman of Biostatistics. 
---++ Percent Efforts
It is departmental policy that the percent efforts of statisticians on grant proposals reflect their anticipated actual efforts. A faculty member may not be on more than 3 projects with less than 7.5% effort each; the minimum percent effort is generally 5%.  Unless the granting agency disallows funding percent efforts, statisticians will not participate on grant applications as internal consultants or be paid a fixed dollar amount or for a fixed number of hours.

We strongly recommend that a grant proposal name both a <nop>PhD and an MS biostatistician as members of the research team, with the ratio of MS:PhD percent efforts being about 2.5:1.

Figuring actual percent efforts on grant proposals is more art than science.  Generally speaking, without sufficient time invested in the proposal, we cannot make accurate estimates of the future effort required for your project.  Factors that necessitate both a !PhD and an MS statistician include:

   1 many variables (measurements) per subject or animal
   1 repeated (serial, longitudinal) measurements per animal or subject
   1 a significant number of subjects dropping out before the planned termination of their follow-up
   1 other types of missing data
   1 plans for sequential monitoring of treatment effects or safety with an eye to possible early termination of the study
   1 data and safety monitoring committees
   1 data from other sources where the data must undergo major transformations or cleaning to be analyzable
   1 data from multiple clinical sites
   1 measurements that are only partially observable (e.g., when concentrations may be below the lower limit of detectabilty)

*Make sure* that in any grant in which you are involved you include the following in the regular budget:
   1 Computer systems analyst support if this support is directly for the aims of the grant, e.g., dealing with large medical databases, web application programming, other data management, programming (especially for simulations).  This would be as a % effort to a named IT member.
   1 Travel to professional meetings if (1) you need to go to a medical/basic science meeting that will give you knowledge to collaborate with the investigators or (2) you need to acquire  methodologic skills that are directly used in the project for which you need to attend a specific session or short course at a statistical meeting.  For (1) funding should be for all costs of the meeting and for (2) funding should be for all or some pro-rated portion of the meeting depending on your % effort on the grant and how directly related the methods are to the grant.
   1 By all means insure that the % effort for the senior + junior biostatistician team are adequate, and the mixture of junior and senior % efforts is appropriate for the expected mixture of Biostat I, II, III, faculty-level tasks involved.


---++[[https://www.mc.vanderbilt.edu/starbrite/research/index.html][StarBrite]]

---++ Other Notes
<!--   
   * Information Technology/Continuing Education Support fee is *%RED%required%ENDCOLOR%*; please see details below
-->
   * Faculty biostatisticians must be designated as Key Personnel
   * Faculty should be designated as a Co-Investigator, when, as a participant in a grant or application he/she contributes substantively to the scientific development or execution of a project or he/she contributes a specified level of time as per NIH guidelines.

<!--
 ---++ Systems Support and Professional Meetings/Continuing Education Costs

 ---+++ Information Technology (IT)
   IT support is mandatory for grant proposals (other than certain K awards) and active projects in order to recoup the following costs:
   * System administration (backup, software installation, system upgrades, security)
   * User support and training

 ---+++ Professional meetings and Continuing Education Costs
   * Ongoing training and education pertinent to research area
   * Modest annual fee for continuing education

*FY 09 Professional Expense and Information Technology Support Fees per Statistician FTE = $10,670* 

The purpose of this fee is to support the Department of Biostatistics computer systems analysts who will be working with the biostatisticians on the proposed research as well as to support continuing education and pertinent professional meetings.

Description of calculation: The "average CSA salary cost per client served" is a calculation of total salary costs of CSA staff broken out between salary costs supported by departmental sources and salary costs supported from outside the department, then divided by the total number of faculty and non-CSA staff to whom they provide IT support within the department.  100% of that portion of the "average CSA salary cost per client served" that is tied to departmental support and 50% of the "average CSA salary cost per client served" that is tied to support from outside the department are summed.  This sum is taken at 50% for system administration and 50% for user support and training. An offset to other costs is added to arrive at the fee per statistician FTE.  Lastly, an annual fee of $2K is added for professional expense.        
-->

---++ Who to contact when considering a new grant proposal
Unless the proposal is a renewal or resubmission (in which case you should contact the biostatisticians currently involved in the project), all requests for assistance on proposals must go to DonnaBock.  If you are unsure about whether the proposal development is covered by an existing relationship with our department, contact FrankHarrell.
-----

---++ eRA Commons User Names
%EDITTABLE{}%
| *Faculty Name* | *eRA Commons <br> User Name* |
| Ayers, Dan | AYERSGD |
| Byrne, Dan | BYRNEDW |
| Chandrasekhar | CHANDRR |
| Chen, Heidi | CHENH5 |
| Chen, Qingxia (Cindy) | CHENQ3 |
| Choi, Leena | CHOILEENA |
| Crimin, Kim | CRIMINKS |
| Dupont, William D | DUPONTTWD |
| Federspiel, Charles | FEDERSCF |
| Fonnesbeck, Chris | !FonnesCJ |
| Gebretsadik, Tebeb | GEBRETT |
| Greevy, Robert | GREEVYRA |
| Harrell, Frank | FHARRELL |
| Koyama, Tatsuki | KOYAMAT |
| Li, Chun | LICHUN3 |
| Li, Ming | LIMING2 |
| Saville, Benjamin | SAVILLBR |
| Schildcrout, Jonathan | SCHILDJS |
| Shepherd, Bryan | SHEPHEB1 |
| Shintani, Ayumi | SHINTAAK |
| Shyr, Yu | SHYRYU |
| Slaughter, Chris | SLAUGHJC |
| Wang, Lily | WANGL8 |
| Wu, Hyiyun (William) | WUWILL |
| Xu, Lei | XULEI5 |
| Yu, Chang | YUCHANG |
| Zhou, Chuan | ZHOUC2 |
| Zhu, Yuwei | ZHUYU1 |


To Administrators:  For instructions to set up an !eRA Commons User Name, [[http://www.vanderbilt.edu/oor/gcm/faq/pi-setup-era-commons.pdf][click here]].

---++Recommended Reading
   * Inouye SK, Fiellin DA. [[http://www.annals.org/cgi/reprint/142/4/274.pdf An evidence-based guide to grant proposals for clinical research]].  Ann Intern Med. 2005;142:274-282. 
   * [[%ATTACHURL%/GrantApplication_Numbers.pdf][Tool for identifying grant ID numbers.]]
   * [[http://ocga.ucsd.edu/Proposals/NIH/Grants/Identification_Numbering_System.htm][eRA Commons Understanding Grant Numbers]]
Topic attachments
I	Attachment	Action	Size	Date	Who	Comment
pdf	GrantApplication_Numbers.pdf	manage	21.7 K	15 Jul 2009 - 09:49	LindaStewart	This helpful tool describes grant ID numbers.
pdf	GrantSubmissionTimeline2008.pdf	manage	19.8 K	13 Nov 2007 - 11:03	DianeKolb	Grant Submission Timeline 2008
pdf	coeus_for_approvers_and_PIs.pdf	manage	710.5 K	05 Jun 2008 - 16:15	DonnaBock	COEUS Premium for PIs and Approvers
Topic revision: r62 - 03 Feb 2014, NanaKwarteng
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