CROHN S & COLITIS FOUNDATION OF AMERICA INSTRUCTIONS. Effective November 2009

Transcription

1 CROHN S & COLITIS FOUNDATION OF AMERICA R ESEARCH I NITIATIVE A WARD INSTRUCTIONS Effective November 2009 Crohn s & Colitis Foundation of America National Office Research & Scientific Programs Department 386 Park Ave South 17 th Floor New York, NY Voice: Ext Web site: grants@ccfa.org MISSION: To cure Crohn s disease and ulcerative colitis, and to improve the quality of life of children and adults affected by these diseases. CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 1

2 RESEARCH INITIATIVE AWARD INSTRUCTIONS CONTENTS General Information 3 Preparing the Application 4-8 Research Plan 9 Evidential Enclosures 10 Curriculum Vitae 10 Optional Appendix 10 Special Instructions for Foreign Applicants 11 Special Instructions for Clinical Trials Authorized Signatures 12 Submission of Electronic Version of Letter of Intent 13 Submission of Electronic Version full Application Assembly and Submission of Paper Copy 17 CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 2

3 GENERAL INFORMATION APPLICATION SUBMISSION AND REQUIRED SIGNATURES Applications must be submitted in two formats: an electronic version and paper copy. The electronic version is submitted using links provided in the Crohn s & Colitis Foundation web site & professionals. The paper (master) copy of the application must have the signatures (see forms section of our web site). The electronic application must be submitted by close of business (5:00 PM Eastern time) on the specified deadline date. If the deadline date falls on a weekend or holiday, applications will be accepted the following business day. Paper copy must be post marked on the deadline date. ACCESSING THE CCFA GRANT APPLICATION SYSTEM NOTE: Adobe Acrobat Reader 5.0 or above is required to use the electronic grant submission system. Access the Crohn s & Colitis Foundation Research site at Select Funding Opportunities followed by Index of Grants. Select the grant for which you are applying. You are now able to access the electronic grant application process. Contact CCFA at Ext.7501 or , grants@ccfa.org to address any problems with preparation or submission of the electronic version of the application. FORMATTING THE APPLICATION Applicants must adhere to the following instructions in completing the proposal sections that make up the electronic version of the application. Failure to observe font size specifications and/or page limits will result in the return of the application without review: Please remember to insert your name in the header on each form in the attachment section. Font size: Use 12 point Times New Roman or 11-point Arial as the minimum font size for the text of the application. A 10-point Times New Roman or 10-point Arial font type may be used for figures, legends, and tables. Single-spaced text is acceptable, and space between paragraphs is recommended. Margins: The margins of your text should be at least 1 inch all around, unless a form with different margins is supplied in the Application Templates or Forms. Fill in all required fields (*) Page numbering: The electronic version is numbered independently. The attachments should be numbered in the lower right hand corner and each section should be numbered independently. CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 3

4 PREPARING THE APPLICATION Some (or all) of the required information will have been automatically filled in from your Letter of Intent submission. Project Title: The title should not exceed 75 characters in length (including spaces). Do not use abbreviations unless absolutely necessary. General Area of Research: Indicate the scientific area(s) of your project (3 max). Challenges Priority: Donors frequently have an interest in funding particular types of IBD research. Please check one Priority Area that is addressed by your project. Principal Investigator: Only one (1) principal investigator will be accepted on a proposal; coinvestigator designations are not allowed. Anyone other than the PI should be listed as: Collaborator - defined as an investigator who is actively involved on a regular basis and shares in the performing of the actual tests or experiments of the research project; Consultant - defined as someone who provides materials or advice but is not actively involved on a regular basis or involved in the actual tests or experiments of the research project; Support personnel - defined as technical support staff. Percentage of effort should be indicated for ALL collaborators and support personnel (See Detailed Budget for Year 1-3). It is the responsibility of the applicant to justify the role of each collaborator and/or consultant. (See also instructions for: Justification of Personnel Budget" and "Evidential Enclosures") Organization Information: Where the PI is currently employed. Fill in all required fields. Resubmissions: Applications that are not funded may be revised and resubmitted no more that 2 times. All resubmissions are competitively reviewed. Any resubmission of a previously submitted proposal should carry the same title as the previous application. Resubmission must include: Reply to Previous Review, letter not to exceed 3 pages. The letter should clearly and succinctly address the points raised in the previous review and direct the reviewer to the specific sections of the Research Protocol where revisions have been made. Revised portions of the text changed in response to the reviewers comments should be highlighted (e.g.: bold type, line in the margin, underlined, etc.). Critiques (Summary Statement) of the original application Budget pages of previous application Overall objectives and specific aims of previous application CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 4

5 Upload all of the above in the Resubmission Section on the attachment section provided. Scientific and Lay Summary of the Project: Scientific Summary of Project: The Scientific Summary should provide a clear, concise overview of the proposed work, including the background, objective, or hypothesis and its supporting rationale; specific aims of the study for general scientific audience. Type the scientific summary into the text box on the e-form. This should be no more than one-half page. Description of Project in Lay Terms: CCFA has instituted a Stakeholder Reviewer Program, in which selected lay people participate as full voting members of the various review committees. Your lay summary should be a clear, concise overview in simplified language, appropriate for non-scientific reviewers. You need to provide enough essential information that the Stakeholder Reviewers will be able to evaluate your application. The lay summary should be no more than 1-2 pages and include the following information: What question will this project attempt to answer? Why is this question important to IBD? What is the study design? How do the hypothesis and specific aims fit with CCFA s scientific priorities? Will this research, if successful, further the CCFA s mission to find the causes and cures of IBD and/or to improve quality of life for IBD patients? If so, how will this project do so? Also include a brief glossary of any scientific terms included in your lay summary. This statement will be evaluated as part of your application as well as used to inform the Foundation s National Board of Trustees and the general public of the natures of this work; therefore, do not include proprietary or confidential information. Pointers: This section must be written in language that is easily understandable to a 6 th -7 th grade reader. Define all scientific terms; Words like pathogenesis or cytokines might be common words to you, but not necessarily to lay persons. TEMPLATE FOR WRITING THE LAY SUMMARY Investigator: Project: Type of Award: Francis Crick, Ph.D. Salk Institute, San Diego, CA The Essential Role of IFN Consensus Sequence-Binding Protein in the Development of Colitis Research Initiative Award Description: In most people, the cells of the immune system fight harmful bacteria and viruses efficiently. They re able to tell the difference between disease-causing pathogens and the harmless, often helpful bacteria that live in the intestine. A key question in IBD is why the immune CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 5

6 system responds aggressively to these harmless, ever-present bacteria, releasing a complex mix of proteins and other substances that cause inflammation in the intestine. Interferon Consensus Sequence-Binding Protein (ICSBP) is one of the substances produced by immune cells in response to bacteria. ICSBP helps determine the amount and type of inflammation that occurs, but the exact role of the protein in inflammation and chronic inflammatory disease is not clear. People with Crohn s disease have higher levels of ICSBP than people without the disease. This is also true for mice with IBD-like disease, and when these mice are engineered without the gene that produces ICSBP, they do not develop colitis, suggesting an essential role for the protein in the development of inflammation. This project determines how ICSBP activity can be manipulated with drugs in mice, and how these manipulations can be used as a strategy for treatment of IBD disease activity. Type the lay summary into the text box on the e-form Significance\Relevance: If successful, this project will establish how to effectively manipulate levels of ICSBP, and whether this type of treatment is an effective treatment for IBD-like diseases in mice. If so, this may lead to the development of therapeutic treatments for IBD based on this strategy. Type the significance into the text box on the e-form. Relevance of the Project to IBD: Use our Challenges Comparison Worksheet on our website at to find out which CCFA scientific priority listed is addressed by your project (choose one only). Human/Animal Studies Approval: All activities involving human subjects or vertebrate animals must be approved by an appropriate institutional review board (IRB) or equivalent prior to the start date of award. Copies of the IRB approval to the CCFA National Office should be sent by mail. If approval is not available at the time of application, provide a date of anticipated approval. This approval must be received before the start date of the approved grant. Grant Administration Information Name and address of the person at the grantee institution who will administer the grant in the event an award is made. Detailed Budget For First Year, Second Year, Third Year Download the budget forms from the form section of our web site and save to your hard drive. Before completing this form, carefully read the instructions for Budget Justification and Budget Policies and Restrictions in the Policy section. Fill in the totals for each year on the e-form. The Detailed Budget forms must also be uploaded on the attachment section provided. Costs must be indicated in U.S. dollars - we will NOT convert. Personnel List all personnel, both salaried and non-salaried. Also note that for every collaborator or consultant listed, there should be an accompanying letter of intent to collaborate in the Evidential Enclosure section. (See Evidential Enclosures). Complete Justification of Personnel Budget CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 6

7 form(s) and add totals to Detailed Budget for year 1; year 2 and Year 3. The Justification of Personnel Budget form(s) must also be uploaded on the attachment section provided. Percentage of Effort Indicate the percent of time each person will devote to this proposed project calculated from his/her total professional work hours based on a 40-hour work week on Justification of Personnel Budget form(s). Salary/Fee Enter dollar amount for any fees or salary requested. Salary support is not considered for students, fellows or trainees. List Salary/Fee on Justification of Personnel Budget form(s). Fringe Benefits Enter the amount of fringe benefits requested. List Fringe Benefits on Justification of Personnel Budget form(s). Totals Total the amount requested for each person. Total the columns to calculate the total salary/fees requested, total fringe benefits requested, and total amount requested for personnel. Transfer the total amount for personnel to the appropriate space in far right column of the Detailed Budget for year 1; year 2; and year 3. Supplies Enter itemized supplies by category and total on the Detailed Budget for year 1; year 2; and year 3. Equipment Enter any requests for equipment on the Detailed Budget for year 1; year 2; and year 3. Note the equipment policy in the Budget section of the Policies. Miscellaneous List miscellaneous items (i.e., subcontracts, patient costs, etc.) and total on the Detailed Budget for year 1; year 2; and year 3. Subcontracts If any portion of the proposed research is to be carried out at another institution, enter the total costs and provide a categorical breakdown of costs using duplicate copy(ies) of the grant application Detailed Budget for the First Year (Form C) and Justification of Personnel Budget pages. A letter of Agreement pertaining to the subcontract should be included in the Appendix. Note: indirect costs for the subcontract budget may be claimed by either the primary or secondary institution, but not by both. CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 7

8 Travel Enter travel expenses and total on the Detailed Budget for year 1; year 2; and year 3. Total Direct Costs Total direct costs per year for Research Initiative Awards may not exceed $130,000. Total Indirect Costs You may calculate up to 10% of total direct costs. This should be according to your institutional policy, but not exceeding 10% of the total direct costs (a maximum of $13,000). Total Budgetary Request for Year 1; Year 2; & Year 3 List total direct and indirect costs. BUDGET FOR ALL YEARS OF REQUESTED SUPPORT 1. Total the direct costs for Salaries, Fringe Benefits, Equipment, Supplies, Travel and Miscellaneous Expenses and enter on the electronic form. 2. Calculate Total Indirect Costs for each year. Enter the percentage for all years on the electronic form. JUSTIFICATIONS OF THE BUDGET Justification of Personnel Budget Download the budget template from the form section of our web site and save to your hard drive. Complete budget page(s) then fill in the total budget for years one to three for PI and all other personnel on the e-form. The budget page(s) will need to be uploaded as an attachment in the attachment section provided Budget Justification: Supplies Itemize and justify (in text box of e-form) the need for any equipment requested for the proposed project, as well as why the equipment is being requested through funds from the CCFA instead of institutional funds. (Note the equipment policy in the Budget section of the Policies.) Budget Justification: Equipment Itemize supplies by category (in text box of e-form) (i.e., glassware, chemical, etc.). Justify the request for supplies, including the quantity. Budget Justification: Miscellaneous Expenses Itemize and justify any miscellaneous expenses (in text box of the e-form). These are any expenses that do not fit clearly into any other category (i.e., patient costs, subcontracting, etc.). If you are subcontracting, upload a detailed budget for that contract arrangement on the attachment section. CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 8

9 Budget Justification: Travel Itemize and justify any travel expenses (in text box of the e-form). State the purpose of travel, the number of persons involved, the number of trips and destinations (i.e., the meeting name), and the significance of the travel to the proposed project. RESEARCH SUPPORT These form(s) need to be completed and uploaded on the attachment section provided. Provide supporting documents after each completed form. The forms can be found in the form section of the CCFA web site. 1. Include all research support (current and pending) for the principal investigator and key collaborators. Collaborator s are exempt from providing research support information if they are not drawing salary from this application. 2. List all public and/or private support, whether or not it is related to this project. 3. You should include the cover face page, specific aims, and budget pages of each current and pending grant proposal. FAILURE TO FULLY DISCLOSE THIS INFORMATION WILL RESULT IN YOUR APPLICATION BEING REJECTED. RESEARCH PLAN (PROTOCOL) 1) Pages can be single spaced and should be numbered starting at Overall Objectives (page 1) and continued through Pertinent References. 2) The Principal Investigator's name should be in the upper right-hand corner of each page. 3) The Research Plan should follow the outline below. SPECIFIC REQUIREMENTS Your Research Plan section of the application should not exceed 20 pages and should include enough information to communicate the necessary information with clarity. A. Overall Objectives: Briefly outline the general scientific objectives in one or two paragraphs. (Should not exceed 1 page) B. Specific Aims: Describe concisely and realistically what the specific research described in this application is intended to accomplish. Specifically outline Aims for year 1, year 2 or year 3, goals, deliverables and timelines. State any hypotheses to be tested. (Should not exceed 1 page) C. Background: Outline the previous work in the area by others, and the preliminary data or previous studies by the investigator(s). Enough preliminary data should be included in the application to demonstrate that the project is feasible and that the investigator is likely to complete the project CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 9

10 successfully in the two years duration of the grant. (Should not exceed 6 pages) If this is a renewal application, include a copy of your most recent progress report here. D. Methods of Procedure and Materials: Provide a detailed discussion of the experimental design, procedures, and materials to be used to accomplish the Specific Aims. Describe protocols, including methods for new techniques, and explain the advantages over existing methodologies. Discuss the kinds of data expected to be obtained and the means by which data will be analyzed and interpreted. Justify the use of any animal models (i.e., choice of species, number used, etc.). Discuss potential difficulties and/or limitations of the proposed procedures and alternative approaches to achieve aims. (Should not exceed 10 pages) E. Significance and Relevance to Inflammatory Bowel Disease: Justify the significance of the results of this project to the understanding of the etiology, pathogenesis, therapy, and prevention of IBD. Specifically identify the gaps this project is intended to fill. (Should not exceed 1 page) F. Facilities Available to Carry out the Proposed Studies: Describe the facilities available, including square footage, equipment, animal care facilities, and other environmental factors. Pay particular attention to those items required for successful completion of this proposal. Include a description for each facility to be involved. (Should not exceed 1 page) G. Pertinent References: Literature citations should be listed in this section, at the end of the Research Plan. These are not counted as part of the 20 page limit. (Should not exceed 3 pages) Number the Research Protocol (pages 1-20) and upload in the attachment section provided EVIDENTIAL ENCLOSURES A. All activities involving human subjects or vertebrate animals must be approved by an appropriate institutional review board (IRB) or equivalent prior to the start date of award. A copy of the actual signed or stamped approval is required. A letter stating that the approval is on file is not adequate. If evidence is unavailable at the time of submission, include a letter from the principal investigator stating intent to forward the evidence upon approval, and an approximate date the foundation will receive that evidence. Multi-center studies require consent from all participating centers. See Human\Animal Experiments Approval. This can also be uploaded if available at the time of application. B. Upload informed consent forms that will be used; if applicable. C. Upload evidence of FDA approval for any experimental drugs. D. Upload letters of intent to collaborate from all professionals and/or institutions outside the principal investigator s laboratory that will be committing time and expertise or donating materials. Upload all that applies in the attachment section provided CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 10

11 CURRICULUM VITAE Curriculum vitae (C.V.) are required for the principal investigator, collaborators, and/or key personnel. This should be in a two-page biosketch format. Included in each C.V. should be: 1. Name 2. Address 3. Academic and Institutional Titles 4. Education (year of degree, degree awarded, institution) 5. Chronological listing of Professional Experience and Positions 6. Publications (past 5 years only) 7. Explain any time lapses in work history (i.e.: maternity leave; military service, etc). Principal investigator only. Upload all pertinent Biosketch s in the attachment section provided OPTIONAL APPENDIX 1. Pertinent published material of the applicant should be included in this section. 2. Include original photographs, etc. Upload all that applies in the attachment section provided Applicants falling into any of the following categories should read the "Special Instructions" section pertaining to them before attempting to complete the application: Foreign Applicants Clinical Trials SPECIAL INSTRUCTIONS FOR FOREIGN APPLICANTS ALL MATERIALS AND REPORTS MUST BE IN ENGLISH. FAILURE TO DO SO WILL RESULT IN A REJECTED APPLICATION. Complete budget request must be in U.S. dollars - We will NOT convert. Please be aware that you should give more details than you might be accustomed, especially in the areas of background material and preliminary data, experimental design, and available facilities, budgetary items (particularly percent of effort and salary requests for key personnel). CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 11

12 SPECIAL INSTRUCTIONS FOR CLINICAL TRIALS The Research Plan will need to include everything required in the Application Preparation section, plus the following information: Specific Aims: These should include a delineation of the primary and secondary end points to be measured with an appropriate explanation of the relative importance of the various end points. Significance: The application should clearly state the need for the study and how the results would impact on the prevailing practice in this area. Experimental Design and Method: The inclusion and exclusion criteria should be listed, and the procedure(s) to be utilized for assignment of patients to experimental groups should be described. The study design for the interventions to be used should be presented in detail including the rationale for the particular design chosen and procedures to assure compliance with and implementation of the proposed protocol. Potential biases in the proposed protocol and how they will be addressed should be presented. Clinical, laboratory, and physiological tests should be described including methods of randomization. Finally, assumptions and calculations to arrive at the proposed sample size should be included. The availability of patients for the proposed study, including the specific characteristics that are required for the group should be presented. Approaches should be outlined that will be used for the recruitment, retention, and follow-up of the required number of patients. Data should be presented supporting recruitment and retention estimates. Plans should be described for patient protection, including informed consent, monitoring of data for safety, and early termination as required. Appropriate informed consent forms from all participating groups (centers) should be included. Certification of approval from the Human Studies Committee (or its equivalent) for each participating institution should also be included. Projected rates of patient enrollment should be included. If enrollment falls behind projected levels, funding may be delayed or terminated. The organization of the study and how the trial will be managed should be described, including the function of any internal or external advisory committees and any data and safety monitoring groups. In multicenter trials, you should provide a description of the responsibility and role of a data coordinating center, and policies and methods concerning blinding of study results. Accordingly, a plan should be submitted describing the procedure for the coordination of all participating centers. The Crohn s & Colitis Foundation does not assume responsibility for the conduct of the activities that the grant supports or the acts of the grant recipient as both are under the direction and control of the grantee institution and subject to the institution s medical and scientific policies. Grantee institutions must safeguard the rights and welfare of individuals who participate as subjects in research activities by reviewing proposed activities through an Institutional Review Board (IRB), as specified by the National Institutes of Health Office for Human Research Protections, US Department of Health and Human Services. Furthermore, grantee institutions must adhere to DHHS guidelines regarding financial conflicts of interest, recombinant DNA, CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 12

13 research misconduct, and vertebrate animals. These policies apply to applicants and applicant institutions as well. Finally, a timetable for completion of the various phases of the trial should be presented. A procedure or plan for data management should be described, including data collection forms, if available. Data analysis methodology linking the analyses to the hypotheses to be tested should also be included. Primary and secondary end points should be clearly defined, justified, and related to the power calculations. Evidential Enclosures: Enclose letters of commitment from each participating center, signed by the cooperating investigator and business official. In addition, informed consent forms and evidence of Human Studies approval from all participating centers should be included in this section. Curriculum Vitae: Biographical sketches of all key investigators, center directors, and multidisciplinary team members should be included (2 PAGES ONLY). Facilities: Clinical, data management, and laboratory facilities should be described in detail for all participating institutions, where applicable. Budget: A total overall budget and a complete justified budget for each year of support should be presented. If the trial is designed for more than the three-year period, complete justified budgets for the future years and a plan for securing funding for additional year(s) must be included. If the study involves multiple centers, a composite matrix should be submitted, where applicable. If part of the costs of the total trial are to be provided by sources other than CCFA, these contributions should be presented in detail along with supporting letters from appropriate and responsible individuals. (Additional budget information will need to be submitted as attachment(s). These forms need to completed and uploaded on the attachment section provided. The forms can be found in the form section of the CCFA web site. Authorized Signatures: Download the signature template from the form section of our web site and save to your hard drive. The original signatures must be included in the paper (master) copy of the application sent to CCFA. Be sure to include the name and title of the institutional authority signatory, who should be the head of the department or a financial officer authorized to commit the applicant institution to sponsoring the project supported by the award. This person may not be the principal investigator. CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 13

14 SUBMISSION OF ELECTRONIC VERSION of Letter of Intent AND Full Application The electronic version is submitted using links provided in the Crohn s & Colitis Foundation web site You will need to create a user ID and password to access the forms. All attachments must be uploaded as.pdf documents. The maximum size for all attachments combined is 10MB. Please note that files with certain extensions such as exe, vbs, or bat, cannot be uploaded. If you need assistance please call the Research Department at LETTER OF INTENT (stage 1 of the application process) Each applicant must submit a letter of intent prior to sending a full application. The Letter of Intent is mandatory. The letter of intent is due on either of the following deadlines: October 1 or May 1. Access to the electronic version will be closed by 5:00pmET on either deadline. Click on the link above to complete the Eligibility Quiz Click Submit (If you have met the eligibility criteria) you can now access the Letter of Intent Forms Fill in all the fields on page 1 Fill in all the fields on page 2 Upload the following attachments on page 3 NIH Biosketch 2 page limit Reference (optional) Then click on Review and Submit Submit your Letter of Intent Application **NOTE: Paper copy of your Letter of Intent is not required. CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 14

15 Below you will find detailed instructions on completing these various sections. You will also find instructions on compiling the paper copy of your application for submission. All application attachments must be uploaded as.pdf documents. FULL APPLICATION (Stage 2 of the application process) The full application is due on either of the following deadlines: July 1 or January 14. Access to the electronic version will be closed by 5:00pmET on either deadline. Complete the electronic version of your application as follows: Application Forms Complete online the electronic version of the forms Fill in all required fields (*) GENERAL AREA OF RESEARCH Select 3 categories from the drop down box TITLE OF PROJECT Fill in project title (If this is a resubmission, the title should be the same as the original application.) PRINCIPAL INVESTIGATOR Fill in the name PI s name PI is defined as the one person responsible to the foundation for scientific and technical direction of the project. FILL IN TEXT BOXES FOR ALL OF THE FOLLOWING: Name: FIRST name, MIDDLE name, LAST name Suffix: (e.g., M.D., Ph.D.) Academic Title: Gender: Country of Citizenship: Address: Complete mailing address for correspondence to the applicant City, State, Zip: Telephone: The phone number at which you are most likely to be reached during the day. Foreign applicants enter country code in parentheses. CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 15

16 Fax and ORGANIZATION INFORMATION (fill in the text boxes for all of the following) Organization Name: Address: City, State, Zip: Fax and Phone: Tax ID Website (www) URL: RESUBMISSION (Leave this section blank if application is new) Please see page 4 of the Instructions for preparing this section. Previous Submission date (Leave this section blank if application is new) Enter here month, day and year of previous submission Previous Submission Score (Leave this section blank if application is new) Enter score received for previous submission SCIENTIFIC \LAY SUMMARY OF THE PROJECT (Type in text (See template on page 5 of Instructions for writing this section) Lay Summary Type in text (See template on page 5 of Instructions for writing this section) Significance of the Project Type in text (See template on page 5 of Instructions for writing this section) Relevance of the Project to IBD Type in text (See template on page 5 of Instructions for writing this section) CHALLENGES COMPARISON Check one only from the drop down HUMAN & ANIMAL EXPERIMENTS APPROVAL (IRB s, IAACUC, etc.) Can be uploaded or sent by standard mail to our National Office GRANT ADMINISTRATION INFORMATION Fill in this section in the event an award is made CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 16

17 BUDGET YEAR 1, YEAR 2, YEAR 3 Download the budget template from the form section of our web site and save to your hard drive. Complete budget page(s) then fill in the total budget for years one to three for PI and all other personnel on the e-form. Note the total budget request per year may not exceed $143,000 ($130,000 direct and $13,000 for indirects). The budget pages will also need to be uploaded as an attachment in the attachment section provided. (See budget instructions on pages 6-8) JUSTIFICATION OF PERSONNEL BUDGET Download the budget template from the form section of our web site and save to your hard drive. Complete budget page(s) then fill in the total budget for years one to three for PI and all other personnel on the e-form. The budget pages will need to be uploaded as an attachment in the attachment section provided. (See budget instructions on pages 6-8) Supply Justification Fill in text box Equipment Justification Fill in text box Travel Justification Fill in text box Miscellaneous Expenses Justification Fill in text box RESEARCH SUPPORT (Form G) Download the Research Support template from the form section of our web site and save to your hard drive. This form need to be completed and uploaded on the attachment section provided. Provide supporting documents after each completed form. ATTACHMENTS For all other attachments complete and upload per instructions. The Principal Investigator's name should appear in the upper right-hand corner of each uploaded.pdf page. Research Protocol should be no more than 20 pages (number pages 1-20) see instructions for completing this section. Upload in attachment section provided. Research Protocol: Overall Objectives Specific Aims Background Methods of Procedure & Materials Significance Facilities Pertinent References (not part of the protocol) CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 17

18 Other attachments: o NIH Biosketch (2 page limit) for PI and Key Personnel o Letters of Collaboration o Informed Consent Forms and FDA Experimental Drug(s) approval o Human & Animal Experiments o Resubmission o Progress Report (is applying for a 3 rd year of funding) o Research Support (Form G) o Evidential Enclosures o Detailed Budget Pages o Appendices (optional) When saving and uploading attachments, please name the files as indicated below: Last name, First name Research Protocol Last name, First name - NIH Biosketch (indicate name of persons biosketch) Last name, First name - Letters of Collaboration Last name, First name - Informed Consent Forms and FDA Experimental Drug(s) approval Last name, First name - Resubmission Materials (if this is a resubmission) Last name, First name - Progress Report (if applying for a 3 rd year of funding) Last name, First name Research Support (Form G) (if more than one Form G page with supporting documents indicate as Form G 1, Form G 2, etc ) Last name, First name Detailed Budget Pages Last name, First name Human & Animal Experiments Last name, First name Appendices Last name, First name Signature page Please make sure all required documents are uploaded and attached to your application, missing documents and data will not be reviewed. Upload all of the above in attachment section provided. CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 18

19 ASSEMBLY AND SUBMISSION OF PAPER COPY The paper copy (master) of the full application must be postmarked on the deadline date (July 1 or January 14) to the Crohn s & Colitis Foundation National Office. The paper (master) copy of the full application must contain assembled in this order: Application Forms (electronic-forms) Budget (all pages) Justification of Personnel Budget (all pages) Research Support (Form G) (all completed forms plus supporting documents) Research Plan (Protocol) Letters of Collaboration NIH Biosketch (2 page limit) for PI and Key Personnel Human & Animal Experiments Informed Consent Forms and FDA Experimental Drug(s) approval Resubmission Evidential Enclosures Signature page Appendices (optional) Mail to: Crohn s & Colitis Foundation of America National Office Research & Scientific Programs Department 386 Park Ave South 17FL New York, NY APPLICATIONS WHICH DO NOT MEET THE REQUIREMENTS, IN CONTENT OR FORMAT WILL NOT BE REVIEWED CCFA RESEARCH INITIATIVE AWARD INSTRUCTIONS 19