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PILOT STUDY AWARD APPLICATIONIrving Institute for Clinical and Translational ResearchandThe Clinical Trials Office2012

Irving Institute/Clinical Trials Office 2012 Pilot Study Award ApplicationApplications are being accepted for one-year, one-time only, individual clinical and translational PILOT grantsof $50,000 each. These Irving Institute/CTO pilot funds are intended primarily for JUNIOR INVESTIGATORSwho have not previously received funding through this mechanism. At award time, qualified applicants musthave an appointment as an Instructor, Assistant Professor (clinical or tenure track) or Associate ResearchScientist at the College of Physicians & Surgeons. U.S. citizenship or permanent residency status is notrequired. Focus of the application should be on PILOT STUDIES which will lead to independent, externalfunding. These awards are not meant to supplement on-going funded research.Departmental Matching Funds ($25,000) Required. Applicants to this program must first contact theirdepartment chair to determine the level of interest in co-sponsorship. NOTE: We cannot accept anyapplication that does not have the prior, written approval of the department chairperson. Departments maywish to conduct their own, intra-departmental competition before approving submission of proposals to thisprogram. Alternatively, departments may be willing to cost-share funds for more than one applicant.Moreover, more than one award recipient may come from the same department, providing departmentalfunds are available and pre-approved.DEFINITION OF CLINICAL AND TRANSLATIONAL RESEARCHRESEARCH DIRECTED TOWARD HUMAN DISEASESRESEARCH SHOULD INVOLVE ONE OR MORE OF THE FOLLOWING: DIRECT CONTACT WITH HUMAN SUBJECTS, INCLUDING THERAPEUTIC TRIALS, STUDIESOF GROUPS OF PATIENTS OR CLINICAL OUTCOMES; LABORATORY STUDIES OF HUMAN BODY FLUIDS, TISSUES, CELLS OR DEVICES; STUDIES IN ANIMAL MODELS OF A DISEASE IN WHICH A THERAPEUTIC APPROACHAND/OR MECHANISM OF DISEASE IS BEING INVESTIGATED.DIRECTIONS:NOTE: Applications with an interdisciplinary and collaborative approachwith other departments or schools are favorably viewed.1. APPLICATIONS MUST INCLUDE A LETTER FROM THE HOME DEPARTMENT CHAIR AGREEING TO THEMATCHING FUNDS MECHANISM TO ASSIST IN SUPPORT OF THIS PROPOSAL.2. Prepare all parts of this application (contact information, abstract, current funding sources, submittedapplications, 12-month budget, budget justification, signature page). Obtain the required departmentalsignatures of approval; attach the Study Protocol and NIH-style biosketches for yourself and any coinvestigators,including eRA Commons usernames.3. Convert the entire packet into a single PDF file that must be submitted electronically no later than5:00pm, WEDNESDAY, February 15, 2012, to:Michelle McClaveCommunications CoordinatorIrving Institute for Clinical and Translational ResearchEmail: mm3098@columbia.edu

Irving Institute/Clinical Trials Office 2012 Pilot Study Award Application4. The Study Protocol may not exceed five (5) single-spaced, typed pages (11 or 12 point font required; Arialtypeface preferred), excluding references. The Protocol should include:A) Goals: What are you planning to do?B) Rationale: Why is it worth doing? What prior studies will the proposed research build upon? How isthe proposed work interdisciplinary?C) Methods: How will the study be conducted? Include a discussion on statistical analysis, e.g., size, power, controls, analysis of data. We strongly encourage applicants to seek consultation with relevant Irving Institute Resourcesprior to submission of this proposal (e.g., Design & Biostatistics, Regulatory and Ethics, CommunityEngagement, Biomedical Informatics). Note that requests for Irving Institute Resources to helpwith grant submissions MUST be submitted at least 4 weeks prior to the proposal due date;otherwise, a request for consultation could be delayed or possibly denied. Requests must be madeonline at the following URL: http://irvinginstitute.columbia.edu/. Our Service Request form maybe found by clicking any one of three buttons on our Web site – RESOURCES, RESEARCH or LINKS,and then selecting SERVICE REQUESTS. To access these services and log in your request, aColumbia UNI, password and eRA Commons Username are required. Will services of Irving Institute Resources be requested/used/needed for carrying out theproposed work?D) Future Plans: What is the next step after receiving pilot funding? What specific grant application(s) do you plan to submit and when? Provide a detailed plan andtimeline for grant applications to the NIH, private foundations, or other external funding sources.This response will be heavily weighted.E) References: No more than fifteen (15).F) NIH-style biosketch for each investigator: Maximum of 4 pages per investigator (including OtherSupport).5. Budget: This one-time award is in the sum of $50,000 ($25,000 from the Irving Institute and $25,000 fromyour home Department). Your detailed budget should directly support your protocol. Each item must bejustified in the budget justification section of the application. Expenses may include salary, equipment,computer costs, etc., but the justification must be clearly stated.6. IRB approval is not required at the time of application.7. Reviewers will use a scoring system based on a 5-point scale and judge each application on the basis ofscientific merit, multidisciplinarity, potential impact of the pilot findings and potential of the juniorinvestigator for independent research career.8. For any questions about the application content, please contact the Director of the Irving Institute’s Pilotand Collaborative Studies Resource, Dr. Nancy Reame, at nr2188@columbia.edu or (212) 305-6761.

Irving Institute/Clinical Trials Office 2012 Pilot Study Award ApplicationFAILURE TO FOLLOW THESE DIRECTIONS WILL RESULT IN THE PROPOSAL BEING RETURNED TOYOU, WITHOUT REVIEW.WHILE NEW, JUNIOR INVESTIGATORS ARE STRONGLY ADVISED TO REVIEW APPLICATIONSWITH SENIOR FACULTY MEMBERS PRIOR TO SUBMISSION, A LETTER FROM HIS/HERDEPARTMENT CHAIR AGREEING TO MATCHING FUNDS MUST ALSO BE INCLUDED.DO NOT INCLUDE APPENDICES.PILOT AWARD WINNERS WILL BE ANNOUNCED IN MAY 2012.FUNDING WILL BE AVAILABLE ON JULY 1, 2012.

Irving Institute/Clinical Trials Office 2012 Pilot Study Award ApplicationNAME:TITLE:HOME DEPARTMENT:LOCAL ADDRESS:EMAIL ADDRESS:NIH eRA Commons user name:TELEPHONE NUMBER:CO-INVESTIGATOR(S) AND CONTACT INFORMATION:(NAME, TITLE, DEPARTMENT, EMAIL ADDRESS, NIH eRA Commons user name)Page 1 of 5

Irving Institute/Clinical Trials Office 2012 Pilot Study Award ApplicationPROJECT TITLE:SYNOPSIS OF PROPOSAL: (use only space provided below – minimum 11 point font)ALL CURRENT SOURCES OF RESEARCH FUNDING (include begin/end dates and total direct costs)Page 2 of 5

Irving Institute/Clinical Trials Office 2012 Pilot Study Award ApplicationPENDING APPLICATIONS FOR RESEARCH FUNDING (include proposed begin/end dates and totaldirect costs)12-MONTH BUDGET (July 1, 2012 to June 30, 2013)SALARIES with FRINGE:EQUIPMENT:SUB-TOTAL $PATIENT CARE COSTS:SUB-TOTAL $ALL OTHER EXPENSES:SUB-TOTAL $SUB-TOTAL $TOTAL PROPOSED BUDGET $Page 3 of 5

Irving Institute/Clinical Trials Office 2012 Pilot Study Award ApplicationDETAILED BUDGET JUSTIFICATION: (use only space provided – minimum 11 point)Page 4 of 5

Irving Institute/Clinical Trials Office 2012 Pilot Study Award ApplicationSIGNATURES OF APPROVALA. I certify that the information presented in this proposal is, to the best of my knowledge, complete,accurate, and developed according to practices commonly accepted within the scientific community._____________________________________________________________________________Signature of Principal InvestigatorDateB. I have reviewed this application and agree to provide matching funds. Furthermore, I hereby takeresponsibility for ensuring that the necessary space, personnel, and facilities which are mentioned inthe application pertaining to my Department will be available for this project should it be funded. Irecommend that this application be submitted._____________________________________________________________________________Signature of Department ChairmanDateREMINDERSPLEASE REVIEW APPLICATION WITH DEPARTMENT CHAIR AND OBTAIN LETTER OF APPROVAL.Page 5 of 5