FIFTH YEAR CLINICAL FELLOWSHIP AWARD POLICIES AND GUIDELINES

Transcription

1 FIFTH YEAR CLINICAL FELLOWSHIP AWARD POLICIES AND GUIDELINES TABLE OF CONTENTS AWARD OVERVIEW & ELIGIBILITY...2 SUBMISSION INFORMATION & GENERAL TIMELINE...2 AWARD DETAILS CFF PAYBACK AGREEMENT APPLICATION REVIEW... 3 ONLINE REGISTRATION & INSTRUCTIONS...4 FACE PAGE BUDGET SUMMARY, DETAIL & JUSTIFICATION...5 LETTERS OF SUPPORT & REFERENCE NAMES & ADDRESSES OF SPONSORS...6 SPONSORS: LIST OF PREVIOUS FELLOWS...6 SPONSORS: OUTCOMES OF PAST & CURRENT CFF/CFFT SUPPORT....6 PREVIOUS TRAINING & FUTURE PLANS...7 PROPOSED TRAINING PLAN RESEARCH PLAN DATA SAFETY-MONITORING PLAN... 9 FACILITIES AVAILABLE.. 10 BIOGRAPHICAL SKETCHES. 10 OTHER SUPPORT PROOF OF CITIZENSHIP/PERMANENT RESIDENCY APPENDICES FINAL STEPS...11 CONTACT INFORMATION...11 CHECKLIST

2 AWARD OVERVIEW & ELIGIBILITY The mission of the Cystic Fibrosis Foundation (CFF) is to cure cystic fibrosis and to provide all people with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualized treatment, and ensuring access to high-quality, specialized care. To meet this mission, various types of grants are offered to support meritorious research ranging from basic laboratory investigation to clinical management of cystic fibrosis (CF). For all awards, proposals are encouraged that involve collaboration between an approved CFF Care Center and an institution with basic and/or clinical research programs. The Fifth Year Clinical Fellowship award offers support for physicians who have completed four years of CF-related fellowship training (generally Pulmonology or Gastroenterology) and seek support for a fifth year. In most circumstances, this year will be devoted to clinical or basic research related to CF. The research potential of the applicant, the scientific merit of the proposed study, the research environment of the training program, and the fellow's commitment to continued involvement with CF research and/or clinical care in an academic setting will be among the major criteria considered in selection. Preference will be given to applicants whose prior training was previously supported by CFF. Applicants who plan to conduct clinical research during this year should pay special attention to Section C (Clinical Research only) of the Research Plan guidelines and to the completion of the Data Safety Monitoring Plan. Eligibility Applications are open only to those in the fourth year of training at an institution. Adult caregivers in CF are encouraged to apply. U.S. citizenship or permanent resident status is required. SUBMISSION INFORMATION Application Deadline: September 2, 2015 at 5:00pm (Eastern Time) Applications must be submitted online at ProposalCENTRAL: The signed Face Page must be scanned and ed to CFF on the same date. General Timeline Review by Research and Research Training Committee December 2015 Review by Medical Advisory Council.January 2016 Review by Board of Trustees.. February 2016 Applicant Notified February 2016 Earliest Start date March 1, 2016 AWARD DETAILS REQUIREMENTS Training must take place in one of the CFF's accredited CF Care Centers or a Center-affiliated adult CF program. The applicant must describe career goals related to a long-term commitment to CF research and/or care. Each fellow must have a Sponsor who will be responsible for the fellow's training and research activities, if applicable. All CFF-supported Clinical Fellows in internal medicine, pulmonology, gastroenterology, family practice, and other specialties must submit a case study to be presented at the annual North American Cystic Fibrosis Conference (NACFC), at either the 2

3 Pediatric Clinical Fellows session or the Adult care Clinical Fellows session. This involves submitting a one-page description of the case, including clearly defined discussion points prior to the conference. Please check the NACFC website at for further details and specific deadlines. Fellowships are not transferable either with respect to the trainee or the trainer, as they are awarded on the basis of individual and institutional merit. AWARD AMOUNT The maximum award amount is $100,000 in direct costs. No indirect costs will be paid to the institution. Base stipend: $80,000. Up to $20,000 for research expenses (supplies, travel, minor equipment, etc) may be requested. In addition to the fellowship itself, the CF Foundation will underwrite the interest payments of the grantee for educational loans for up to $7,000 per year. This requires a separate application after the fellowship is awarded. Payments are made to the sponsoring institution on a quarterly basis in arrears, with each of the first three payments made at the end of each grant quarter. The final payment is made only after the final progress report and the final expense report is received from the sponsoring institution. CFF PAYBACK AGREEMENT The applicant is required to sign the payback agreement provided online, and upload it as a PDF into the application. CFF expects that upon completion of a CFF fellowship, the recipient will engage in biomedical research, teaching, and patient care, or a combination of these activities, in an academic environment. Failure to commence these activities or sustain them for a period equal to that of CFF support will incur payback obligations for every fellowship year beyond the first. The payback amounts are $23,500 for the second year of support, and $33,000 additional for each year beyond. Length of Support Payback Amount 1 year N/A 2 years $23,500 3 years $56,500 4 years $89,500 5 years $122,500 APPLICATION REVIEW Basic science projects are reviewed by the Research and Research Training (RRT), and clinically-based projects by the Clinical Research Committee (CRC). The committees recommendations are reviewed by the Medical Advisory Council (MAC) and the Board of Trustees for final approval and funding. Funding decisions are based on the priority score awarded each application and the recommendations of the RRT or CRC, and the MAC. All fellowships awarded are subject to the observance of the regulations, policies and objectives of CFF related to that category of research support, and are contingent upon the availability of funds. Chief causes for low priority scores include the following: 1. Insufficient information or documentation. 2. Inadequate statement of hypothesis, experimental design or methods. 3. Failure of the applicant to demonstrate awareness of and plans for coping with key problems and pitfalls associated with the proposed research. Such pitfalls may include insufficient numbers of potential study subjects, insufficient project duration to accomplish aims, or lack of documentation of access to necessary databases. 3

4 4. Insufficient or improper controls, especially in human clinical studies. 5. Failure to describe potential relevance of the proposed study to issues in CF. 6. Failure to document the necessary skills/training to accomplish the proposal s goals. 7. Failure to meet all of the criteria described in the policy statement for a given award. 8. Failure to describe career development goals as they may be related to a long-term commitment to CF research. 9. Insufficient evidence of Sponsor s involvement in the development of the research plan. ONLINE REGISTRATION & INSTRUCTIONS Application Deadline: September 2, 2015, 5:00pm (Eastern) Submit online at ProposalCENTRAL: Register at ProposalCENTRAL if you are a first time user. If you have registered before, and cannot remember your password, click on the Forgot Password button. Grant opportunities, including this, are listed on the opening screen, but you must log in first, then click on the gray tab labeled GRANT OPPORTUNITIES in order to see the APPLY NOW button appear next to the program name. Click on that button to begin. Application Sections are listed in the gray menu box to the left of the screen. The sections need not be complete sequentially. Click the red SAVE button after completing each section. You may stop at any point in the application, each time remembering to SAVE your entries, and return to continue, revise, and upload until you have actually hit the SUBMIT button. When you log in to continue, click on the blue tab, MANAGE PROPOSALS, and then the Edit button next to your application s title. Do not start a new application. Download the templates and instructions in Section 2 of the application. Complete the forms offline and upload in Section 10. The applicant or designee must upload the documents. Complete Section 3 online if you wish to designate access to another individual, such as an assistant who has registered on ProposalCENTRAL. Enter the full name and address and in the Permissions column, then use the pulldown menu to select the type of access you wish to give. FACE PAGE The Face Page will be populated automatically with the data (applicant s name, institution, title of application, etc.) entered into different sections in the online. It must be downloaded as one of the final steps. The Applicant (or Principal Investigator), the applicant s Sponsor(s), and the official authorized to sign on behalf of the Sponsoring Institution are each required to sign where indicated on the application Face Page. Scan the signed Face Page and the PDF to grants@cff.org by the same date as the deadline. No hardcopy is required. ABSTRACTS, SUMMARY OF RELEVANCE, & KEYWORDS Provide the following information in the boxes online, either typing in directly or cutting and pasting in plain text (no formatting, e.g. bold or underline; or scientific symbols.) 4

5 Lay Abstract Provide a statement of no more than 250 words (up to 2,000 characters max, including spaces) on the research subject and its relationship to CF, writing to an informed lay readership. This abstract will be used to inform the non-scientific departments of CFF and the general public of the proposed research. Do not include proprietary information. Scientific Abstract This abstract will be used to inform the scientific community of the proposed research. Provide a statement of no more than 250 words (up to 2,000 characters max, including spaces) describing the research subject and its relationship to CF. Do not include proprietary information. Summary of Relevance All applications are reviewed and scored not only on scientific merit but also on relevance to CFF s mission. The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualized treatment, and ensuring access to high- quality, specialized care. Provide a statement of no more than 250 words (up to 2,000 characters max, including spaces) summarizing the relevance of the proposed research to the health and well being of CF patients, for a scientific audience who may or may not have a background in the subspecialty of the proposed research. Keywords From the lists of options in the pull-down menus, select all applicable research topics, keywords, and relevant areas of CF research for the proposed project. A minimum of one option must be selected per category. BUDGET SUMMARY, DETAIL, & JUSTIFICATION Budget Summary (Online form). Complete the budget form for one year of support. Detailed Budget The maximum level of support is $100,000, direct costs only. CFF does not provide indirect costs on fellowship grants. Only one year of support should be requested. Personnel Enter the name and title of the applicant. Indicate dollar amounts separately for salary and fringe benefits. Fringe benefits may be requested if they are treated consistently by the applicant institution as a direct cost to all grant sponsors. The total salary and benefits cannot exceed $80,000. Equipment - List all items of minor equipment requested, their cost and a brief justification. If funds are requested to purchase equipment that is equivalent to items listed under Facilities Available, justify the duplication. Computers, laptops, and/or other computer equipment are not allowable expenses on fellowship grants. Supplies - Itemize supplies, such as glassware, chemicals, animals, etc., in separate categories and give the estimated cost of each category. If animals are involved, state the number, unit purchase cost, and unit care cost. Travel - Describe the purpose of any travel. Funds for travel outside the North American continent are not permitted. Requests for travel funds should be limited to $1,250. Other Expenses - Itemize other expenses by major categories, such as duplication costs, publication costs, etc. Justify all items. Budget Justification Use this page to describe the costs listed in the Detailed Budget, by major categories, e.g. Personnel, Supplies. 5

6 LETTERS OF SUPPORT & REFERENCE Letters of Support and Reference are weighted heavily during the review. At least five (5) Letters of Support/Reference must be provided and submitted electronically through the ProposalCENTRAL website before the application is submitted. Invite Sponsors and Referees to Submit Letters through ProposalCENTRAL Please start this process early as this involves a multi-step process. Letters of Support/Reference must be submitted electronically by each Sponsor/Referee through ProposalCENTRAL. Go to Section 6. Letters of Support/Reference of the online application, and enter their names and addresses. Automated s (with instructions) will be sent to each Sponsor/Referee through the ProposalCENTRAL website. Letters of Support The Sponsor(s) should describe the types of CF learning experiences to which the applicant will be exposed. If the application includes a research project, the letter should detail how the Sponsor(s) will provide the applicantwith the tools and resources necessary for her/him to develop into a CF-focused independent investigator. The CF Center Director(s) at the sponsoring (or nearby) institution (if s/he is not a Sponsor.) See above. The Applicant s Division or Section Chief, if s/he is not the Center Director should detail career and faculty development plans and opportunities, as well as institutional resources available and relevant to the applicant. Letters of Reference The Sponsor(s) of the first three years of the clinical fellowship training should address what the applicant has achieved in his/her prior fellowship training. At least one other individual familiar with the applicant s scientific interests and abilities should attest to the candidate's academic qualifications, motivation, research potential and commitment to CF research and care. Use the form provided, and upload a PDF copy. NAMES AND ADDRESSES OF SPONSOR(S)/REFERENCES SPONSORS: LIST OF PREVIOUS FELLOWS (For Sponsors to complete, and the applicant to upload.) Using the template provided, the current Sponsor(s) must provide a list of all previous fellows under his/her supervision over the past 10 years, including the fellows source(s) of support. SPONSORS: OUTCOMES OF PAST & CURRENT CFF/CFFT SUPPORT (For Sponsors to complete, and the applicant to upload.) Sponsors are requested to identify the outcomes of past and current CFF/CFFT funding they have received in the past three to five years. (e.g. subsequent funding from other sources, journal articles, and invited presentations). A form is provided on ProposalCENTRAL to be downloaded for the Sponsor(s) to complete. The completed form should be uploaded by the applicant. Note: If a Sponsor has never received CFF/CFFT support, please indicate that on the form, and upload as instructed. For each CFF/CFFT research project listed by the sponsor(s), the following information is required: CFF/CFFT Account # Principal Investigator (PI) CFF/CFFT Project Title 6

7 Role on Project (e.g., PI, Co-PI) Project Start/End Dates Total CFF/CFFT Award Amount Outcomes of Support PREVIOUS TRAINING AND FUTURE PLANS A template is provided for a brief description of the first four years of the applicant s clinical fellowship and a summary of future plans in CF-related research and/or clinical care. There is no page limit, but please be concise. PROPOSED TRAINING PLAN A template is provided, to be completed in conjunction with the Sponsor(s), for an outline of a training plan for the applicant. The anticipated clinic and rounds schedule should be included, as well as information on participation in supplemental course work and special seminars. Estimates of time dedicated to research/scholarly pursuits and clinical care should be delineated. Maximum five (5) pages. RESEARCH PLAN The research plan should include sufficient information in the research plan to permit effective review without reference to previous applications. Key figures and legends must be included within the Research Plan, and not uploaded in an attachment. The Literature Cited is not included in the page limit of seven (7). If this application is a resubmission, the changes should be clearly indicated by a change in the font, underlining, or italics. If the revisions are not apparent, the resubmission will not be reviewed. A. Hypothesis and Specific Aims. (Maximum length: one page). State concisely and realistically the intent of the proposed research and the hypothesis to be tested. Note the relevance of these aims to CFF s mission. (See page 1.) B. Background and Significance. Critically evaluate existing knowledge and specifically identify the gaps that the project is intended to fill. Concisely state the importance and rationale of this research by relating the specific aims to longer-term objectives. Demonstrate the potential importance of the proposed work to CF. Describe the relationship of the proposed work to long-term career goals. Preference will be given to those applicants who have expressed an interest in a long-term career in CF-related research. C. Preliminary Results. If applicable, provide a detailed discussion of any preliminary results. If the application is a competitive renewal of a previously funded CFF Clinical Fellowship, a specific discussion of progress made during the previous funding period should be included. D. Experimental Design and Methods. Provide a detailed discussion of the experimental design and methods to be used to accomplish the specific aims. Describe the protocols, including methods for new techniques, and explain potential advantages over existing methodologies. Discuss the data expected to be obtained and the means by which data will be analyzed and interpreted. If clinical studies are involved, provide details of the methods for patient selection and care. Discuss potential difficulties and/or limitations of the proposed procedures and alternative approaches to achieve aims. Point out any procedures, situations or materials that may be hazardous to personnel or patients, and the precautions to be exercised. Experimental Design and Methods (for applicants proposing to carry out Clinical Research through this support mechanism). Provide a detailed discussion of the experimental design and procedures to be used to accomplish specific aims. Discuss study hypothesis; primary and secondary outcome measures; study design; study sample- inclusion and exclusion criteria; sample size estimates;* subject enrollment including age range; puberty status; gender distribution; randomization 7

8 scheme if applicable; description of experimental procedures and schedule including a study time-line; drugs and dosage; measures of compliance; follow- up schedule including a time-line; drugs and dosage; measures of compliance; follow-up schedule including a time-line for full project up to three years; ascertainment of response variables: efficacy and safety, training, data collection, data monitoring and quality control; and a description of your proposed data analysis and statistical procedures for your hypothesis testing. Although no page limit is specified for this section, make every attempt to be concise and succinct. *For sample size estimates, provide all estimates of means, standard deviations, rates or proportions used to calculate each of your sample size or power estimates. Include in the statistical section whether you will use a one or two-tailed test, the power selected for such a test (if making a sample size calculation), and the reference for your sample size or power calculation. In instances of pilot studies where some of these parameters are unknown, we will accept your best estimates of the unknown parameters if preliminary data are not available, and if your calculation is a preliminary estimate before formal sample size can be calculated for a larger study. Identify if you are making estimates from data or from personal estimates. Document access to adequate numbers of subjects. Specify the number of CF patients in the participating CF Center(s), as well as the number in relevant control groups. Discuss the potential difficulties and limitations of the proposed procedures and alternative strategies for achieving the aims. Provide a copy of your institution s IRB approval and/or protocol with proposed patient consent forms. E. Literature Cited. References should be numbered in the sequence that they appear in the text and listed at the end of the Research Plan. Each citation must include the names of authors, the name of the journal or book, volume number, page number and year of publication (titles are optional). DATA SAFETY MONITORING PLAN For Clinical Research Projects In compliance with Federal regulations, all applicants must submit a general description of the Data Safety Monitoring Plan (DSMP) for any proposed study that places human subjects at more than minimal risk.(template provided online). A DSMP helps to ensure subject safety, as well the validity and integrity of the data. Furthermore, a DSMP allows for the monitoring of study data to assess whether or not an early termination is necessary for safety or efficacy reasons. The extent of monitoring required for a study is dependent on the level of risk involved for the subjects, as well as the size and complexity of the study. CFFT-funded Phase III clinical trials must utilize a Data Safety and Monitory Board (DSMB). In addition, CFFT recommends that investigators utilize a DSMB for any Phase I or II clinical trials that are: multi- center, blinded to the investigator; conducted in an emergency setting; use high-risk interventions, such as gene therapy or gene transfer; or include particularly vulnerable study populations, such as pediatric patients. Address the following areas in the DSMP: Assessment of Risk (see the following Assessment of Risk Table ) Describe the level of risk the proposed research presents to subject participants and provide a detailed justification for the level of risk. Discuss who will monitor the study. Anticipated Adverse Events and Grading Scale Describe anticipated adverse events (AEs), including expected frequency and the grading scale to be used. Discuss plans for addressing AEs. Reporting of AEs Detail the plan for reporting AEs, including who shall be notified in the event an AE should occur. Safety Monitoring Plan Describe all tests, evaluations, and exclusion criteria that will be implemented to ensure and monitor the safety of human subjects. Discuss plans for stopping the study if necessary. Safety Reviews Describe the process for monitoring and reviewing subject safety data, including the frequency of such reviews. Include details as to who will perform the monitoring and plans for reporting. If utilizing a DSMB, provide a composition of the board, the functions of the board, the frequency of meetings, the reporting requirements, including AEs, and the procedure for interim reporting as necessary. 8

9 ASSESSMENT OF RISK TABLE Minimal Risk Low Risk Moderate Risk High Risk Study poses no more risk than expected in daily life (blood draw, physical exam, etc.) Behavioral studies Nutritional studies Observational studies MRI studies Survey or questionnaire studies Studies of normal Subjects treated with volunteers using well- placebo for a recognized described research disease; procedures (IV Involves subjects with infusion, euglycemic HIV/AIDS, hepatitis, or clamp, etc.) cancer on a treatment Studies which might study meet requirements Substantial risk (>5%) of a for minimal review Serious Adverse Event but include special originating from the populations or underlying condition of invasive the enrolled subject procedures Phase I or II study with Post-marketing available safety data in study Phase IV drug humans or device, as Industry sponsored defined by FDA Phase III clinical trial Involves an intervention or invasive procedure with substantial risk An investigator-initiated IND trial Implantation of device with an IDE Involves the use of a new chemical or drug for which there is little or no toxicology data in humans A gene therapy study or research involving recombinant DNA molecules (gene transfer); Investigator-initiated multi- center trial Investigator-initiated Phase III clinical trial Involves the manufacturing of agents on campus Study has provisions to waive consent in emergency circumstances Involves vulnerable populations (e.g. pediatric, pregnant, etc.) Blinded Phase I & II trials ORGANIZATION ASSURANCES & CERTIFICATIONS Research Involving Human Subjects CFF policy pertaining to the protection of individuals as research subjects requires that for each proposal submitted, the applicant institution certify in writing that an Institutional Review Board (IRB) has reviewed and approved the procedures for the use of human subjects, or human organs, tissues and body fluids, in the proposed research, in accordance with Department of Health and Human Services policies. This certification should accompany the application and must be received before activation of any grant. If approval does not accompany the application, there should be a statement in the application indicating that such approval is pending and the date when such approval is expected. The IRB application must be submitted to the applicant institution before the CFF application deadline. The approved certification should be submitted upon award. Research Involving Recombinant DNA All research involving recombinant deoxyribonucleic acid (DNA) techniques and human gene transfer supported by CFF must meet the requirements contained in the document NIH Guidelines for Research Involving Recombinant DNA Molecules (revised October 2011). This publication and announcements of modifications and changes to the NIH Guidelines are available from the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC7985, Bethesda, MD, or accessed online at The purpose of the NIH Guidelines is to specify practices for the construction and handling of: (i) recombinant deoxyribonucleic acid (DNA) molecules, and (ii) organisms and viruses containing recombinant DNA molecules. As defined by the NIH Guidelines, recombinant DNA molecules are either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or (ii) molecules that result from the replication of those described in (i) above. Many types of studies involving recombinant DNA are exempt from the NIH Guidelines while others are prohibited. The applicant organization is required to establish and implement policies that provide for the safe conduct of the research in full conformity with the NIH Guidelines. This responsibility includes establishing an Institutional Biosafety Committee to review all recombinant DNA research to be conducted at or sponsored by the applicant organization, and to approve those projects it finds are in conformity with the Guidelines. CFF policy pertaining to recombinant DNA research requires that the applicant institution certify in writing that an institutional committee has reviewed and approved the procedures involving recombinant DNA in accordance with the NIH Guidelines. Applicants that do not have institutional committee approval must submit a recombinant DNA application to the applicant institution BEFORE the CFF application deadline. Certifications do not need to accompany the application; however, applicants must provide copies of all required certifications upon CFF s request. 9

10 Research Involving Animals Grant applications submitted to CFF involving the use of animals must meet the guidelines of the National Institutes of Health, U.S. Public Health Service, which require that all proposed studies be reviewed and approved by an Institutional Animal Care and Use Committee (IACUC). In addition, CFF grantee institutions and laboratories must be accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC) and/or have other verifiable assurances that the institution and laboratory meet appropriate standards. If not, applicants must submit an IACUC application to the institution BEFORE the CFF application deadline. Certifications need not be submitted with the application, but must be provided upon CFF s request. FACILITIES AVAILABLE A template is provided. There is no page limit. Use continuation pages if necessary. Describe the institution s facilities and equipment that will be used for this project, their pertinent capabilities, proximity and anticipated extent of use. Describe facilities in terms of relevant areas, such as laboratory, clinical, animal, computer, office, etc. Provide any additional information about the environment, including any support services available that will be utilized for this project. If facilities or equipment at a consultant s or collaborative site will be used, those should be identified and clearly described. BIOGRAPHICAL SKETCHES An NIH Biographical Sketch (either the previous or current version) should be completed for all key project personnel, beginning with the Applicant/Principal Investigator (fellow), and the Sponsor(s). CFF defines key project personnel as any individual with an advanced degree who will play an instrumental role in the accomplishment of the research project. A Sample NIH Biographical Sketch is provided for download. Combine and upload all biosketches as one PDF in Section 10. OTHER SUPPORT NIH Other Support Format Pages should be completed for all key project personnel, i.e. any individual with an advanced degree that will play an instrumental role in the accomplishment of the research project. There is no page limitation for Other Support. A Sample NIH Other Support Format Page is available for download on ProposalCENTRAL. The completed documents should be uploaded together in one PDF. PROOF OF CITIZENSHIP CFF fellowships are restricted to individuals who are United States citizens or Permanent Residents. Proof of Citizenship or Permanent Residency must be provided (e.g., copy of passport, birth certificate, or green card). A legible, PDF copy of the Applicant/Principal Investigator s Proof of Citizenship or Permanent Residency should be uploaded in Section 10. CRITIQUE RESPONSE(S) For resubmissions only. If the application is a resubmission or a competitive renewal of a previously awarded Clinical Fellowship, please provide a point-by-point response to the prior reviews, to address their concerns, and highlight how the research plan has been modified to incorporate their feedback. There is no page limit but please be concise. 10

11 Appendices are restricted to the following three (3) categories: APPENDICES 1. For clinical research, certification of IRB approval, or a statement that it is pending approval and the approximate date available. 2. PDFs may be uploaded of up to three (3) items of the applicant s work related to the proposed research. 3. Other materials pertinent to the grant proposal, not already described. Applications containing Appendices outside of the above-listed categories will be administratively declined, and applicants may be asked to re-submit. Figures and/or legends uploaded as Appendices will NOT be accepted. FINAL STEPS 1. Validate: Upon completing your application, click on the blue VALIDATE button on the main screen. Attend to any omissions/errors as prompted onscreen, if prompted, and VALIDATE again. 2. Print face page: After validation, follow the prompts to print the system-generated face page. 3. Submit: Click on the gray button with blue lettering. CFF will not receive your application until and unless you have submitted it. You will receive an confirmation from proposalcentral (not from CFF) that your application has been successfully uploaded. This will be your only acknowledgment. If you do not receive it, please contact ProposalCENTRAL immediately to ensure that the application is properly submitted. 4. Sign, scan and the face page to grants@cff.org by the deadline date. The Applicant (Principal Investigator), the applicant s Sponsor, and the official authorized to sign on behalf of the institution are all required to sign. CONTACT INFORMATION For all technical questions concerning the online application, contact ProposalCENTRAL: pcsupport@altum.com Mon.-Fri., 8:30 a.m. 5:00p.m. (Eastern). (Or click Customer Service on the upper right of each screen.) For program questions, contact CFF Grants and Contracts: or grants@cff.org Please write Application Inquiry in the Subject line. 11

12 APPLICATION CHECKLIST Application Deadline: September 2, 2015 at 5:00pm (Eastern Time) Submit online at ProposalCENTRAL: the signed face page to by the same date. Face Page (System-generated) Signatures Principal Investigator(PI)/Fellow Sponsor(s) The Official authorized to sign on behalf of the Sponsoring Institution Applicant/PI Professional Profile (online) Names and Addresses of: Lead Institution, Signing Official, and Sponsor(s) Organization Assurances (online) Human Subjects Certification Recombinant DNA Biosafety information Research Involving Animals information Research Plan, Supporting Documents and Appendices Abstracts, Summary of Relevance, Keywords Budget and Budget Justification Facilities Available Biosketches for all key personnel (NIH Format) Other Support for all key personnel (NIH Format) Proof of Citizenship Letters of Support/Reference Names and Addresses of Sponsor(s)/References Letters uploaded online by each Sponsor/Referee at ProposalCENTRAL at least one (1) week prior to application deadline. Sponsors: List of Previous Fellows Sponsors: Outcomes of Past and Current CFF/CFFT Support Description of Previous Training/Future Plans Training Plan Research Plan Hypothesis and Specific Aims Background and Significance Preliminary Results Experimental Design and Methods Literature Cited (not included in Research Plan page limitation) Data Safety Monitoring Plan (For Clinical Research projects with Low/Moderate/High patient risk) CFF Payback Agreement with Signature Appendices Certification of IRB approval, or statement indicating that such approval is pending with the date when such approval is expected (if applicable) Up to three (3) items of the applicant s work relating to the general area of research in the grant proposal Other materials pertinent to the grant proposal, not already described